Trial Outcomes & Findings for This Study Observes the Usage of Non-vitamin K Antagonist Oral Anticoagulants (NOACs) in Elderly Patients With a Heart Rhythm Disorder in Spain (NCT NCT03993119)
NCT ID: NCT03993119
Last Updated: 2021-09-29
Results Overview
Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to sex is reported.
Recruitment status
COMPLETED
Target enrollment
500 participants
Primary outcome timeframe
At the single study visit (Day 1).
Results posted on
2021-09-29
Participant Flow
This was a non-Interventional, cross-sectional study to describe NOACs management in elderly patients with non-valvular atrial fibrillation (NVAF) in Spain. RE-BELD Study.
All subjects were screened for eligibility prior to participation in the study. Study visit was a routine visit, one of those visits already scheduled in order to follow up the patients' NVAF (Non-Valvular Atrial Fibrillation). Patients were considered included when they agreed to participate in the study and signed the informed consent form.
Participant milestones
| Measure |
Dabigatran
Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
Rivaroxaban
Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
Apixaban
Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
192
|
76
|
166
|
66
|
|
Overall Study
COMPLETED
|
192
|
76
|
166
|
66
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dabigatran
n=192 Participants
Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
Rivaroxaban
n=76 Participants
Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
Apixaban
n=166 Participants
Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
Edoxaban
n=66 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
80.83 Years
STANDARD_DEVIATION 4.50 • n=192 Participants
|
80.89 Years
STANDARD_DEVIATION 4.64 • n=76 Participants
|
82.29 Years
STANDARD_DEVIATION 4.90 • n=166 Participants
|
82.02 Years
STANDARD_DEVIATION 4.80 • n=66 Participants
|
81.48 Years
STANDARD_DEVIATION 4.73 • n=500 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=192 Participants
|
46 Participants
n=76 Participants
|
94 Participants
n=166 Participants
|
33 Participants
n=66 Participants
|
250 Participants
n=500 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=192 Participants
|
30 Participants
n=76 Participants
|
72 Participants
n=166 Participants
|
33 Participants
n=66 Participants
|
250 Participants
n=500 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Weight (Kg)
|
76.33 Kilogram (kg)
STANDARD_DEVIATION 11.53 • n=143 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
73.23 Kilogram (kg)
STANDARD_DEVIATION 13.57 • n=70 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
74.63 Kilogram (kg)
STANDARD_DEVIATION 13.40 • n=155 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
71.59 Kilogram (kg)
STANDARD_DEVIATION 12.41 • n=63 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
74.52 Kilogram (kg)
STANDARD_DEVIATION 12.75 • n=431 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Weight categorical
≤60 kg
|
13 Participants
n=143 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
12 Participants
n=70 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
23 Participants
n=155 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
14 Participants
n=63 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
62 Participants
n=431 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Weight categorical
>60 kg
|
130 Participants
n=143 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
58 Participants
n=70 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
132 Participants
n=155 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
49 Participants
n=63 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
369 Participants
n=431 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Height
|
163.86 centimeter (cm)
STANDARD_DEVIATION 8.28 • n=128 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
160.88 centimeter (cm)
STANDARD_DEVIATION 8.88 • n=68 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
162.64 centimeter (cm)
STANDARD_DEVIATION 9.61 • n=138 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
162.93 centimeter (cm)
STANDARD_DEVIATION 7.75 • n=45 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
162.77 centimeter (cm)
STANDARD_DEVIATION 8.86 • n=379 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Body Mass Index
|
28.58 kilogram/meter^2 (kg/m^2)
STANDARD_DEVIATION 4.06 • n=127 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
28.13 kilogram/meter^2 (kg/m^2)
STANDARD_DEVIATION 4.77 • n=67 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
28.32 kilogram/meter^2 (kg/m^2)
STANDARD_DEVIATION 4.71 • n=136 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
27.46 kilogram/meter^2 (kg/m^2)
STANDARD_DEVIATION 3.88 • n=44 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
28.27 kilogram/meter^2 (kg/m^2)
STANDARD_DEVIATION 4.42 • n=374 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Body mass index categorical (BMI cat)
Underweight: BMI< 18.5 kg/m2
|
0 Participants
n=127 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
0 Participants
n=67 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
0 Participants
n=136 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
0 Participants
n=44 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
0 Participants
n=374 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Body mass index categorical (BMI cat)
Normal weight: 18.5 kg m2≤ BMI≤ 25 kg/m2
|
25 Participants
n=127 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
16 Participants
n=67 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
36 Participants
n=136 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
12 Participants
n=44 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
89 Participants
n=374 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Body mass index categorical (BMI cat)
Overweight: 25 kg/m2< BMI≤ 30 kg/m2
|
61 Participants
n=127 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
31 Participants
n=67 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
55 Participants
n=136 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
21 Participants
n=44 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
168 Participants
n=374 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Body mass index categorical (BMI cat)
Obese: 30 kg/m2<BMI≤ 35 kg/m2
|
33 Participants
n=127 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
17 Participants
n=67 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
33 Participants
n=136 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
9 Participants
n=44 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
92 Participants
n=374 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Body mass index categorical (BMI cat)
Severely Obese: BMI> 35 kg/m2
|
8 Participants
n=127 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
3 Participants
n=67 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
12 Participants
n=136 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
2 Participants
n=44 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
25 Participants
n=374 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Caregiver
No
|
93 Participants
n=169 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
41 Participants
n=71 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
78 Participants
n=160 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
39 Participants
n=63 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
251 Participants
n=463 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Caregiver
Yes
|
76 Participants
n=169 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
30 Participants
n=71 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
82 Participants
n=160 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
24 Participants
n=63 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
212 Participants
n=463 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Place where patient is living
Home alone
|
17 Participants
n=187 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
19 Participants
n=72 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
23 Participants
n=164 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
10 Participants
n=66 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
69 Participants
n=489 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Place where patient is living
At home with partner/other family member/a friend
|
147 Participants
n=187 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
52 Participants
n=72 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
119 Participants
n=164 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
45 Participants
n=66 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
363 Participants
n=489 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Place where patient is living
Other's home (e.g. family member's)
|
15 Participants
n=187 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
1 Participants
n=72 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
17 Participants
n=164 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
9 Participants
n=66 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
42 Participants
n=489 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Place where patient is living
Nursing home
|
8 Participants
n=187 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
0 Participants
n=72 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
5 Participants
n=164 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
2 Participants
n=66 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
15 Participants
n=489 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Smoking habit
Ex-smoker
|
66 Participants
n=183 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
17 Participants
n=75 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
43 Participants
n=163 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
19 Participants
n=65 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
145 Participants
n=486 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Smoking habit
Smoker
|
6 Participants
n=183 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
1 Participants
n=75 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
4 Participants
n=163 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
1 Participants
n=65 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
12 Participants
n=486 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Smoking habit
Non-smoker
|
111 Participants
n=183 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
57 Participants
n=75 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
116 Participants
n=163 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
45 Participants
n=65 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
329 Participants
n=486 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Alcohol consumption
Casual or non-consumer
|
149 Participants
n=168 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
66 Participants
n=72 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
134 Participants
n=148 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
56 Participants
n=60 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
405 Participants
n=448 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Alcohol consumption
Habitual
|
19 Participants
n=168 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
6 Participants
n=72 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
13 Participants
n=148 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
3 Participants
n=60 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
41 Participants
n=448 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Alcohol consumption
Abuse
|
0 Participants
n=168 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
0 Participants
n=72 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
1 Participants
n=148 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
1 Participants
n=60 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
2 Participants
n=448 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
|
Alcohol consumption
Dependence
|
0 Participants
n=168 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
0 Participants
n=72 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
0 Participants
n=148 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
0 Participants
n=60 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
0 Participants
n=448 Participants • Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
|
PRIMARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to sex is reported.
Outcome measures
| Measure |
Sex: Male
n=250 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=250 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex
Current NOAC: Dabigatran (110 mg BID and 150 mg BID patients)
|
115 Participants
|
77 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex
Current NOAC: Rivaroxaban (15 mg QD and 20 mg QD patients)
|
30 Participants
|
46 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex
Current NOAC: Apixaban (2.5 mg BID and 5 mg BID patients)
|
72 Participants
|
94 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex
Current NOAC: Edoxaban (30 mg QD and 60 mg QD patients)
|
33 Participants
|
33 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex
Dabigatran 110 mg BID
|
56 Participants
|
41 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex
Dabigatran 150 mg BID
|
59 Participants
|
36 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex
Rivaroxaban 15 mg QD
|
8 Participants
|
23 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex
Rivaroxaban 20 mg QD
|
22 Participants
|
23 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex
Apixaban 2.5 mg BID
|
31 Participants
|
43 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex
Apixaban 5 mg BID
|
41 Participants
|
51 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex
Edoxaban 30 mg QD
|
13 Participants
|
18 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex
Edoxaban 60 mg QD
|
20 Participants
|
15 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to sex is reported.
Outcome measures
| Measure |
Sex: Male
n=250 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=250 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Sex
|
2.43 Years
Standard Deviation 2.19
|
2.22 Years
Standard Deviation 1.83
|
—
|
—
|
PRIMARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' age is reported.
Outcome measures
| Measure |
Sex: Male
n=210 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=152 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=138 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical)
Current NOAC: Dabigatran (110 mg BID and 150 mg BID patients)
|
93 Participants
|
59 Participants
|
40 Participants
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical)
Current NOAC: Rivaroxaban (15 mg QD and 20 mg QD patients)
|
34 Participants
|
23 Participants
|
19 Participants
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical)
Current NOAC: Apixaban (2.5 mg BID and 5 mg BID patients)
|
59 Participants
|
48 Participants
|
59 Participants
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical)
Current NOAC: Edoxaban (30 mg QD and 60 mg QD patients)
|
24 Participants
|
22 Participants
|
20 Participants
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical)
Dabigatran 110 mg BID
|
22 Participants
|
39 Participants
|
36 Participants
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical)
Dabigatran 150 mg BID
|
71 Participants
|
20 Participants
|
4 Participants
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical)
Rivaroxaban 15 mg QD
|
10 Participants
|
9 Participants
|
12 Participants
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical)
Rivaroxaban 20 mg QD
|
24 Participants
|
14 Participants
|
7 Participants
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical)
Apixaban 2.5 mg BID
|
16 Participants
|
21 Participants
|
37 Participants
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical)
Apixaban 5 mg BID
|
43 Participants
|
27 Participants
|
22 Participants
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical)
Edoxaban 30 mg QD
|
7 Participants
|
11 Participants
|
13 Participants
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical)
Edoxaban 60 mg QD
|
17 Participants
|
11 Participants
|
7 Participants
|
—
|
PRIMARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patient's age (categorical) is reported.
Outcome measures
| Measure |
Sex: Male
n=210 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=152 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=138 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Patient's Age (Categorical)
|
2.33 Years
Standard Deviation 2.07
|
2.32 Years
Standard Deviation 1.93
|
2.32 Years
Standard Deviation 2.05
|
—
|
PRIMARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to a prior diagnosis of heart failure is reported.
Outcome measures
| Measure |
Sex: Male
n=316 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=184 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure
Current NOAC: Dabigatran (110 mg BID and 150 mg BID patients)
|
129 Participants
|
63 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure
Current NOAC: Rivaroxaban (15 mg QD and 20 mg QD patients)
|
54 Participants
|
22 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure
Current NOAC: Apixaban (2.5 mg BID and 5 mg patients)
|
96 Participants
|
70 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure
Current NOAC: Edoxaban (30 mg QD and 60 mg QD patients)
|
37 Participants
|
29 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure
Dabigatran 110 mg BID
|
63 Participants
|
34 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure
Dabigatran 150 mg BID
|
66 Participants
|
29 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure
Rivaroxaban 15 mg QD
|
21 Participants
|
10 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure
Rivaroxaban 20 mg QD
|
33 Participants
|
12 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure
Apixaban 2.5 mg BID
|
31 Participants
|
43 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure
Apixaban 5 mg BID
|
65 Participants
|
27 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure
Edoxaban 30 mg QD
|
16 Participants
|
15 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure
Edoxaban 60 mg QD
|
21 Participants
|
14 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to a prior diagnosis of heart failure is reported.
Outcome measures
| Measure |
Sex: Male
n=316 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=184 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to a Prior Diagnosis of Heart Failure
|
2.27 Years
Standard Deviation 2.02
|
2.41 Years
Standard Deviation 2.02
|
—
|
—
|
PRIMARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the study visit according to patients' coronary artery disease is reported.
Outcome measures
| Measure |
Sex: Male
n=414 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=82 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease
Current NOAC: Dabigatran (110 mg BID and 150 mg BID patients)
|
156 Participants
|
35 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease
Current NOAC: Rivaroxaban (15 mg QD and 20 mg QD patients)
|
63 Participants
|
13 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease
Current NOAC: Apixaban (2.5 mg BID and 5 mg BID patients)
|
142 Participants
|
21 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease
Current NOAC: Edoxaban (30 mg QD and 60 mg QD patients)
|
53 Participants
|
13 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease
Dabigatran 110 mg BID
|
78 Participants
|
19 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease
Dabigatran 150 mg BID
|
78 Participants
|
16 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease
Rivaroxaban 15 mg QD
|
23 Participants
|
8 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease
Rivaroxaban 20 mg QD
|
40 Participants
|
5 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease
Apixaban 2.5 mg BID
|
62 Participants
|
10 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease
Apixaban 5 mg BID
|
80 Participants
|
11 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease
Edoxaban 30 mg QD
|
23 Participants
|
8 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease
Edoxaban 60 mg QD
|
30 Participants
|
5 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' coronary artery disease is reported.
Outcome measures
| Measure |
Sex: Male
n=414 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=82 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Coronary Artery Disease
|
2.38 Years
Standard Deviation 2.02
|
2.04 Years
Standard Deviation 1.99
|
—
|
—
|
PRIMARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' diabetes is reported.
Outcome measures
| Measure |
Sex: Male
n=346 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=154 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes
Current NOAC: Dabigatran (110 mg BID and 150 mg BID patients)
|
135 Participants
|
57 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes
Current NOAC: Rivaroxaban (15 mg QD and 20 mg QD patients)
|
51 Participants
|
25 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes
Current NOAC: Apixaban (2.5 mg BID and 5 mg BID patients)
|
113 Participants
|
53 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes
Current NOAC: Edoxaban (30 mg QD and 60 mg QD patients)
|
47 Participants
|
19 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes
Dabigatran 110 mg BID
|
68 Participants
|
29 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes
Dabigatran 150 mg BID
|
67 Participants
|
28 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes
Rivaroxaban 15 mg QD
|
22 Participants
|
9 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes
Rivaroxaban 20 mg QD
|
29 Participants
|
16 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes
Apixaban 2.5 mg BID
|
51 Participants
|
23 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes
Apixaban 5 mg BID
|
62 Participants
|
30 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes
Edoxaban 30 mg QD
|
21 Participants
|
10 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes
Edoxaban 60 mg QD
|
26 Participants
|
9 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' diabetes is reported.
Outcome measures
| Measure |
Sex: Male
n=346 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=154 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Diabetes
|
2.39 Years
Standard Deviation 2.00
|
2.17 Years
Standard Deviation 2.07
|
—
|
—
|
PRIMARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' chronic kidney disease is reported.
Outcome measures
| Measure |
Sex: Male
n=408 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=92 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease
Current NOAC: Dabigatran (110 mg BID and 150 mg BID patients)
|
166 Participants
|
26 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease
Current NOAC: Rivaroxaban (15 mg QD and 20 mg QD patients)
|
64 Participants
|
12 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease
Current NOAC: Apixaban (2.5 mg BID and 5 mg BID patients)
|
130 Participants
|
36 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease
Current NOAC: Edoxaban (30 mg QD and 60 mg QD patients)
|
48 Participants
|
18 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease
Dabigatran 110 mg BID
|
76 Participants
|
21 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease
Dabigatran 150 mg BID
|
90 Participants
|
5 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease
Rivaroxaban 15 mg QD
|
19 Participants
|
12 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease
Rivaroxaban 20mg QD
|
45 Participants
|
0 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease
Apixaban 2.5 mg BID
|
43 Participants
|
31 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease
Apixaban 5 mg BID
|
87 Participants
|
5 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease
Edoxaban 30 mg QD
|
17 Participants
|
14 Participants
|
—
|
—
|
|
Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease
Edoxaban 60 mg QD
|
31 Participants
|
4 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' chronic kidney disease is reported.
Outcome measures
| Measure |
Sex: Male
n=408 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=92 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Chronic Kidney Disease
|
2.34 Years
Standard Deviation 2.05
|
2.25 Years
Standard Deviation 1.89
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Serum creatinine concentration from the last available blood sample analysis was retrieved from patients' medical records. Serum creatinine concentration from the last available blood sample analysis according to current NOAC type is reported.
Outcome measures
| Measure |
Sex: Male
n=159 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=63 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=122 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=47 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Serum Creatinine Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
|
1.00 milligram/deciliter (mg/dl)
Standard Deviation 0.23
|
1.05 milligram/deciliter (mg/dl)
Standard Deviation 0.29
|
1.15 milligram/deciliter (mg/dl)
Standard Deviation 0.41
|
1.14 milligram/deciliter (mg/dl)
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Results from the last available blood sample analysis from patients' medical records were used to retrieve the creatinine clearance (CrCl). These results were directly collected in the Electronic Case Report Form (eCRF). In cases where CrCl was not available in patients's medical record but serum creatinine was available, CrCl was estimated using Cockcroft-Gault formula: CrCl = (140 - Age(years)) x Weight (kilogram) x \[0.85 if female\] / 72 x \[Serum Creatinine (milligram/deciliterL)\] Reported are Crcl values which are calculated according to: * Cockcroft-Gault formula and CrCl values directly collected in the eCRF * Cockcroft-Gault formula only * Directly collected in the eCRF
Outcome measures
| Measure |
Sex: Male
n=141 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=71 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=156 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=46 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Creatinine Clearance From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
CrCl calculated by Cockcroft-Gault formula and CrCl values directly collected in the eCRF
|
63.50 milliliter/minute (ml/min)
Standard Deviation 18.49
|
55.42 milliliter/minute (ml/min)
Standard Deviation 17.59
|
54.45 milliliter/minute (ml/min)
Standard Deviation 18.65
|
53.04 milliliter/minute (ml/min)
Standard Deviation 18.40
|
|
Creatinine Clearance From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Calculated by Cockcroft-Gault formula only
|
62.72 milliliter/minute (ml/min)
Standard Deviation 18.82
|
54.59 milliliter/minute (ml/min)
Standard Deviation 17.79
|
53.77 milliliter/minute (ml/min)
Standard Deviation 19.35
|
52.83 milliliter/minute (ml/min)
Standard Deviation 18.84
|
|
Creatinine Clearance From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Directly collected in the eCRF
|
66.27 milliliter/minute (ml/min)
Standard Deviation 17.27
|
59.98 milliliter/minute (ml/min)
Standard Deviation 16.47
|
56.30 milliliter/minute (ml/min)
Standard Deviation 16.69
|
53.59 milliliter/minute (ml/min)
Standard Deviation 17.69
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Results from the last available blood sample analysis from patients' medical records were used to retrieve the creatinine clearance (CrCl). These results were directly collected in the Electronic Case Report Form (eCRF). In cases where CrCl was not available in patients' medical record but serum creatinine was available, CrCl was estimated using Cockcroft-Gault formula: CrCl = (140 - Age(years)) x Weight (kilogram) x \[0.85 if female\] / 72 x \[Serum Creatinine (milligram/deciliterL)\] The number of participants for each of the following creatinine clearance (CrCl) ranges is reported: * CrCl ≥90: Kidney damage with normal or increased glomerular filtration rate (GFR) * CrCl 60-89: Kidney damage with mild decreased GFR * CrCl 30-59: Moderate decrease in GFR * CrCl 15-29: Severe decrease in GFR * CrCl \<15: Kidney failure
Outcome measures
| Measure |
Sex: Male
n=141 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=71 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=156 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=63 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Participants in Each Category of Creatinine Clearance Range From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
<15 ml/min/1.73m^2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Each Category of Creatinine Clearance Range From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
15-29 ml/min/1.73m^2
|
0 Participants
|
3 Participants
|
10 Participants
|
7 Participants
|
|
Number of Participants in Each Category of Creatinine Clearance Range From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
30-59 ml/min/1.73m^2
|
72 Participants
|
41 Participants
|
92 Participants
|
37 Participants
|
|
Number of Participants in Each Category of Creatinine Clearance Range From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
60-89 ml/min/1.73m^2
|
55 Participants
|
25 Participants
|
46 Participants
|
18 Participants
|
|
Number of Participants in Each Category of Creatinine Clearance Range From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
≥90 ml/min/1.73m^2
|
14 Participants
|
2 Participants
|
8 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Results from the last available blood sample analysis from patients' medical records were used to retrieve AST concentration. AST concentration from the last available blood sample according to non-vitamin K antagonist oral anticoagulant (NOAC) type is reported.
Outcome measures
| Measure |
Sex: Male
n=128 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=62 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=138 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=59 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Aspartate Aminotransferase (AST) Concentration From the Last Available Blood Sample According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
|
24.13 international units per liter (IU/L)
Standard Deviation 11.34
|
21.60 international units per liter (IU/L)
Standard Deviation 7.43
|
25.57 international units per liter (IU/L)
Standard Deviation 16.01
|
20.81 international units per liter (IU/L)
Standard Deviation 8.58
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Results from the last available blood sample analysis from patients's medical records were used to retrieve ALT concentration. ALT concentration from the last available blood sample according to NOAC type is reported.
Outcome measures
| Measure |
Sex: Male
n=127 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=66 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=143 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=62 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Alanine Aminotransferase (ALT) From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
|
22.38 units per liter (UI/L)
Standard Deviation 13.66
|
18.28 units per liter (UI/L)
Standard Deviation 8.95
|
21.52 units per liter (UI/L)
Standard Deviation 17.81
|
20.15 units per liter (UI/L)
Standard Deviation 20.76
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Results from the last available blood sample analysis from patients's medical records were used to retrieve bilirubin concentration. Bilirubin concentration from the last available blood sample according to NOAC type is reported.Results from the last available blood sample analysis from patients' medical records were used to retrieve bilirubin concentration. Bilirubin concentration from the last available blood sample according to NOAC type is reported.
Outcome measures
| Measure |
Sex: Male
n=103 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=53 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=119 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=45 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Bilirubin Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
|
0.83 milligram/deciliter (mg/dl)
Standard Deviation 0.47
|
0.79 milligram/deciliter (mg/dl)
Standard Deviation 0.51
|
0.74 milligram/deciliter (mg/dl)
Standard Deviation 0.47
|
0.75 milligram/deciliter (mg/dl)
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Results from the last available blood sample analysis from patients' medical records were used to retrieve haemoglobin concentration. Haemoglobin concentration from the last available blood sample according to NOAC type is reported.
Outcome measures
| Measure |
Sex: Male
n=181 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=75 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=165 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=64 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Haemoglobin Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
|
13.23 gram/deciliter (g/dl)
Standard Deviation 1.66
|
13.37 gram/deciliter (g/dl)
Standard Deviation 1.61
|
12.99 gram/deciliter (g/dl)
Standard Deviation 1.90
|
13.17 gram/deciliter (g/dl)
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Results from the last available blood sample analysis from patients's medical records were used to retrieve platelet levels. Platelet levels from the last available blood sample according to NOAC type is reported.
Outcome measures
| Measure |
Sex: Male
n=174 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=73 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=160 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=64 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Platelet Levels From the Last Available Blood Sample According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
|
203.37 x 10^3/microliter (μL)
Standard Deviation 60.50
|
222.07 x 10^3/microliter (μL)
Standard Deviation 77.13
|
215.59 x 10^3/microliter (μL)
Standard Deviation 81.48
|
189.45 x 10^3/microliter (μL)
Standard Deviation 68.80
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Results from the last available blood sample analysis from patients' medical records were used to retrieve serum creatinine, ALT, AST, bilirubin, hemoglobin concentration and platelet levels. For each reported laboratory parameter the values were categorized in two categories: Serum creatinine: * Normal value : 0.6-1.2 mg/dl in males and 0.5-1.1 mg/dl in females * High/low value ALT: * Normal values: 7-55 units per liter (UI/L) * High/low values AST: * Normal values: 8-48 UI/L * High/low values Bilirubin: * Normal values: 0.2-1.2 milligram per deciliter (mg/dl) * High/low values Haemoglobin: * Normal values: 12-18 gram/deciliter (g/dL) * High/low values Platelets: * Normal values: 150-450 x10\^3/µL * High/low values
Outcome measures
| Measure |
Sex: Male
n=192 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=76 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=166 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=66 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients in Each Category of Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Hemoglobin and Platelet Levels According to Current Non-vitamin K Antagonist Oral (NOAC) Type
Serum creatinine · Normal levels
|
132 Participants
|
44 Participants
|
72 Participants
|
32 Participants
|
|
Number of Patients in Each Category of Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Hemoglobin and Platelet Levels According to Current Non-vitamin K Antagonist Oral (NOAC) Type
Serum creatinine · High/low levels
|
27 Participants
|
19 Participants
|
50 Participants
|
15 Participants
|
|
Number of Patients in Each Category of Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Hemoglobin and Platelet Levels According to Current Non-vitamin K Antagonist Oral (NOAC) Type
AST · Normal levels
|
122 Participants
|
61 Participants
|
127 Participants
|
59 Participants
|
|
Number of Patients in Each Category of Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Hemoglobin and Platelet Levels According to Current Non-vitamin K Antagonist Oral (NOAC) Type
AST · High/low levels
|
6 Participants
|
1 Participants
|
11 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Hemoglobin and Platelet Levels According to Current Non-vitamin K Antagonist Oral (NOAC) Type
ALT · Normal levels
|
121 Participants
|
65 Participants
|
133 Participants
|
59 Participants
|
|
Number of Patients in Each Category of Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Hemoglobin and Platelet Levels According to Current Non-vitamin K Antagonist Oral (NOAC) Type
ALT · High/low levels
|
6 Participants
|
1 Participants
|
10 Participants
|
3 Participants
|
|
Number of Patients in Each Category of Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Hemoglobin and Platelet Levels According to Current Non-vitamin K Antagonist Oral (NOAC) Type
Total bilirubin · Normal levels
|
91 Participants
|
46 Participants
|
109 Participants
|
41 Participants
|
|
Number of Patients in Each Category of Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Hemoglobin and Platelet Levels According to Current Non-vitamin K Antagonist Oral (NOAC) Type
Total bilirubin · High/low levels
|
12 Participants
|
7 Participants
|
10 Participants
|
4 Participants
|
|
Number of Patients in Each Category of Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Hemoglobin and Platelet Levels According to Current Non-vitamin K Antagonist Oral (NOAC) Type
Hemoglobin · Normal levels
|
143 Participants
|
63 Participants
|
121 Participants
|
50 Participants
|
|
Number of Patients in Each Category of Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Hemoglobin and Platelet Levels According to Current Non-vitamin K Antagonist Oral (NOAC) Type
Hemoglobin · High/low levels
|
38 Participants
|
12 Participants
|
44 Participants
|
14 Participants
|
|
Number of Patients in Each Category of Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Hemoglobin and Platelet Levels According to Current Non-vitamin K Antagonist Oral (NOAC) Type
Platelet · Normal levels
|
140 Participants
|
65 Participants
|
128 Participants
|
48 Participants
|
|
Number of Patients in Each Category of Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Hemoglobin and Platelet Levels According to Current Non-vitamin K Antagonist Oral (NOAC) Type
Platelet · High/low levels
|
34 Participants
|
8 Participants
|
32 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: At the single study visit (day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
The number of years since NVAF diagnosis was obtained from number of years between date of NVAF diagnosis and date of study visit. The date of NVAF diagnosis was retrieved from patient's medical records. The number of years since NVAF diagnosis and date of study visit is reported for: * All patients; * Patients treated previously with vitamin K antagonists (VKA); * Patients treated with NOAC as first anticoagulant .
Outcome measures
| Measure |
Sex: Male
n=192 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=76 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=165 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=66 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Years Since NVAF Diagnosis According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
All patients
|
4.78 Years
Standard Deviation 4.26
|
5.85 Years
Standard Deviation 4.70
|
6.01 Years
Standard Deviation 6.54
|
5.63 Years
Standard Deviation 4.99
|
|
Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Years Since NVAF Diagnosis According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Patients treated previously with VKA
|
6.30 Years
Standard Deviation 4.59
|
7.95 Years
Standard Deviation 4.87
|
7.60 Years
Standard Deviation 5.43
|
7.59 Years
Standard Deviation 4.94
|
|
Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Years Since NVAF Diagnosis According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Patients treated with NOAC as first anticoagulant
|
2.79 Years
Standard Deviation 2.71
|
3.52 Years
Standard Deviation 3.21
|
3.95 Years
Standard Deviation 7.28
|
1.72 Years
Standard Deviation 1.74
|
SECONDARY outcome
Timeframe: At the single study visit (day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
NVAF was categorized in four categories: * Persistent; * Long standing persistent; * Permanent; * Paroxysmal.
Outcome measures
| Measure |
Sex: Male
n=189 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=71 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=160 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=63 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of NVAF Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Persistent
|
32 Participants
|
11 Participants
|
31 Participants
|
12 Participants
|
|
Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of NVAF Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Long standing persistent
|
21 Participants
|
3 Participants
|
10 Participants
|
5 Participants
|
|
Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of NVAF Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Permanent
|
99 Participants
|
26 Participants
|
66 Participants
|
36 Participants
|
|
Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of NVAF Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Paroxysmal
|
37 Participants
|
31 Participants
|
53 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: At the single study visit (day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
The European Heart Rhythm Association (EHRA) score of atrial fibrillation is a classification system for the extent of atrial fibrillation. It places patients in one of five categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. The EHRA categories are the following: 1-no symptoms 2a-mild symptoms; normal daily activity not affected. 2b-moderate symptoms; normal daily activity not affected. 3-severe symptoms; normal daily activity affected. 4-disabling; normal daily activity discontinued.
Outcome measures
| Measure |
Sex: Male
n=188 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=69 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=157 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=62 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of EHRA Scale for Atrial Fibrillation (AF) Related Symptoms According to Current NOAC Type
2a-mild
|
83 Participants
|
30 Participants
|
70 Participants
|
31 Participants
|
|
Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of EHRA Scale for Atrial Fibrillation (AF) Related Symptoms According to Current NOAC Type
2b-moderate
|
45 Participants
|
11 Participants
|
28 Participants
|
11 Participants
|
|
Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of EHRA Scale for Atrial Fibrillation (AF) Related Symptoms According to Current NOAC Type
3-severe
|
10 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
|
Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of EHRA Scale for Atrial Fibrillation (AF) Related Symptoms According to Current NOAC Type
4-disabling
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of EHRA Scale for Atrial Fibrillation (AF) Related Symptoms According to Current NOAC Type
1-none
|
47 Participants
|
25 Participants
|
52 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Number of patients with (category Yes) and without (category No) cardioversion, ablation, coronary interventions and pacemaker carrier according to current NOAC type is reported.
Outcome measures
| Measure |
Sex: Male
n=192 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=76 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=166 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=66 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients in Each Category of Cardioversion, Ablation, Coronary Interventions and Pacemaker Carrier According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Cardioversion · No
|
171 Participants
|
70 Participants
|
151 Participants
|
57 Participants
|
|
Number of Patients in Each Category of Cardioversion, Ablation, Coronary Interventions and Pacemaker Carrier According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Cardioversion · Yes
|
16 Participants
|
6 Participants
|
14 Participants
|
9 Participants
|
|
Number of Patients in Each Category of Cardioversion, Ablation, Coronary Interventions and Pacemaker Carrier According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Ablation · No
|
178 Participants
|
75 Participants
|
160 Participants
|
64 Participants
|
|
Number of Patients in Each Category of Cardioversion, Ablation, Coronary Interventions and Pacemaker Carrier According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Ablation · Yes
|
11 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
|
Number of Patients in Each Category of Cardioversion, Ablation, Coronary Interventions and Pacemaker Carrier According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Coronary interventions · No
|
167 Participants
|
65 Participants
|
148 Participants
|
60 Participants
|
|
Number of Patients in Each Category of Cardioversion, Ablation, Coronary Interventions and Pacemaker Carrier According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Coronary interventions · Yes
|
22 Participants
|
11 Participants
|
17 Participants
|
5 Participants
|
|
Number of Patients in Each Category of Cardioversion, Ablation, Coronary Interventions and Pacemaker Carrier According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Pacemaker carrier · No
|
166 Participants
|
67 Participants
|
151 Participants
|
58 Participants
|
|
Number of Patients in Each Category of Cardioversion, Ablation, Coronary Interventions and Pacemaker Carrier According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Pacemaker carrier · Yes
|
23 Participants
|
9 Participants
|
15 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Participants of FAS who underwent coronary interventions.
Number of patients in each category of coronary interventions according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. Coronary interventions were categorized in: * Percutaneous coronary intervention and * Coronary artery bypass grafting.
Outcome measures
| Measure |
Sex: Male
n=22 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=11 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=17 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=5 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients in Each Category of Coronary Interventions According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Percutaneous coronary intervention
|
19 Participants
|
9 Participants
|
14 Participants
|
4 Participants
|
|
Number of Patients in Each Category of Coronary Interventions According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Coronary artery bypass grafting
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Number of patients in each category of heart failure, coronary artery disease, sleep apnoea-hypopnoea syndrome, hypertension and hyperlipidaemia according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. Heart failure, coronary artery disease, sleep apnoea-hypopnoea syndrome, hypertension and hyperlipidaemia were categorized in the following two categories: * No; * Yes.
Outcome measures
| Measure |
Sex: Male
n=192 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=76 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=166 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=66 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Clinical Risk Factors: Number of Patients in Each Category of Heart Failure, Coronary Artery Disease, Sleep Apnoea-hypopnoea Syndrome, Hypertension and Hyperlipidaemia According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Heart failure · No
|
129 Participants
|
54 Participants
|
96 Participants
|
37 Participants
|
|
Clinical Risk Factors: Number of Patients in Each Category of Heart Failure, Coronary Artery Disease, Sleep Apnoea-hypopnoea Syndrome, Hypertension and Hyperlipidaemia According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Heart failure · Yes
|
63 Participants
|
22 Participants
|
70 Participants
|
29 Participants
|
|
Clinical Risk Factors: Number of Patients in Each Category of Heart Failure, Coronary Artery Disease, Sleep Apnoea-hypopnoea Syndrome, Hypertension and Hyperlipidaemia According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Coronary artery disease · No
|
156 Participants
|
63 Participants
|
142 Participants
|
53 Participants
|
|
Clinical Risk Factors: Number of Patients in Each Category of Heart Failure, Coronary Artery Disease, Sleep Apnoea-hypopnoea Syndrome, Hypertension and Hyperlipidaemia According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Coronary artery disease · Yes
|
35 Participants
|
13 Participants
|
21 Participants
|
13 Participants
|
|
Clinical Risk Factors: Number of Patients in Each Category of Heart Failure, Coronary Artery Disease, Sleep Apnoea-hypopnoea Syndrome, Hypertension and Hyperlipidaemia According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Sleep apnoea-hypopnoea syndrome · No
|
170 Participants
|
70 Participants
|
152 Participants
|
57 Participants
|
|
Clinical Risk Factors: Number of Patients in Each Category of Heart Failure, Coronary Artery Disease, Sleep Apnoea-hypopnoea Syndrome, Hypertension and Hyperlipidaemia According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Sleep apnoea-hypopnoea syndrome · Yes
|
19 Participants
|
6 Participants
|
11 Participants
|
9 Participants
|
|
Clinical Risk Factors: Number of Patients in Each Category of Heart Failure, Coronary Artery Disease, Sleep Apnoea-hypopnoea Syndrome, Hypertension and Hyperlipidaemia According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Hypertension · No
|
46 Participants
|
13 Participants
|
22 Participants
|
7 Participants
|
|
Clinical Risk Factors: Number of Patients in Each Category of Heart Failure, Coronary Artery Disease, Sleep Apnoea-hypopnoea Syndrome, Hypertension and Hyperlipidaemia According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Hypertension · Yes
|
146 Participants
|
63 Participants
|
144 Participants
|
59 Participants
|
|
Clinical Risk Factors: Number of Patients in Each Category of Heart Failure, Coronary Artery Disease, Sleep Apnoea-hypopnoea Syndrome, Hypertension and Hyperlipidaemia According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Hyperlipidaemia · No
|
76 Participants
|
28 Participants
|
68 Participants
|
17 Participants
|
|
Clinical Risk Factors: Number of Patients in Each Category of Heart Failure, Coronary Artery Disease, Sleep Apnoea-hypopnoea Syndrome, Hypertension and Hyperlipidaemia According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Hyperlipidaemia · Yes
|
116 Participants
|
48 Participants
|
97 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Participants of FAS with heart failure. NYHA classification for heart failure patients is missing.
The NYHA provides a simple way of classifying the extent of heart failure and it has 4 categories: * A - No objective evidence of cardiovascular disease * B - Objective evidence of minimal cardiovascular disease * C - Objective evidence of moderately severe cardiovascular disease * D - Objective evidence of severe cardiovascular disease Number of heart failure patients in each category of New York Heart Association (NYHA) classification according to current NOAC type is reported.
Outcome measures
| Measure |
Sex: Male
n=61 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=20 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=61 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=22 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Clinical Risk Factors: Number of Heart Failure Patients in Each Category of New York Heart Association (NYHA) Classification According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
A - No objective evidence of cardiovascular disease
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Clinical Risk Factors: Number of Heart Failure Patients in Each Category of New York Heart Association (NYHA) Classification According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
B - Objective evidence of minimal cardiovascular disease
|
39 Participants
|
12 Participants
|
25 Participants
|
8 Participants
|
|
Clinical Risk Factors: Number of Heart Failure Patients in Each Category of New York Heart Association (NYHA) Classification According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
C - Objective evidence of moderately severe cardiovascular disease
|
18 Participants
|
6 Participants
|
29 Participants
|
12 Participants
|
|
Clinical Risk Factors: Number of Heart Failure Patients in Each Category of New York Heart Association (NYHA) Classification According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
D - Objective evidence of severe cardiovascular disease
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Left ventricular ejection fraction (LVEF) according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. LVEF was obtained from the patients' medical records.
Outcome measures
| Measure |
Sex: Male
n=181 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=58 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=130 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=57 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Clinical Risk Factors: Left Ventricular Ejection Fraction According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
|
59.47 percent ejection fraction (%)
Standard Deviation 9.66
|
59.43 percent ejection fraction (%)
Standard Deviation 10.45
|
58.85 percent ejection fraction (%)
Standard Deviation 12.27
|
57.91 percent ejection fraction (%)
Standard Deviation 12.57
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Up to 12 comorbidities with various weightings can result in a maximum score of 24. The minimum score is zero.
Outcome measures
| Measure |
Sex: Male
n=192 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=75 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=165 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=66 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Age-adjusted Charlson Comorbidity Index Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
|
5.26 Score on a scale
Standard Deviation 1.74
|
5.39 Score on a scale
Standard Deviation 1.63
|
5.99 Score on a scale
Standard Deviation 2.04
|
6.27 Score on a scale
Standard Deviation 2.41
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Number of patients with (Yes) and without (No) the comorbidities which were included in the Charlson Comorbidity Index according to current NOAC type is reported. The comorbidities which were included in the Charlson Comorbidity Index were the following: * Myocardial infarction * Congestive heart failure * Peripheral vascular disease * Cerebrovascular disease * Dementia * Chronic Obstructive Pulmonary Disease (COPD) * Connective tissue disease * Peptic ulcer disease * Liver disease (No/Mild/Moderate to severe) * Diabetes mellitus (No/Uncomplicated/End-organ damage) * Hemiplegia * Moderate to severe renal disease * Solid Tumor (No/Localized/Metastatic) * Leukaemia * Lymphoma * Acquired Immune Deficiency Syndrome (AIDS).
Outcome measures
| Measure |
Sex: Male
n=192 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=76 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=166 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=66 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Diabetes mellitus: Uncomplicated
|
48 Participants
|
18 Participants
|
36 Participants
|
11 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Myocardial infarction; No
|
176 Participants
|
65 Participants
|
147 Participants
|
55 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Myocardial infarction; Yes
|
16 Participants
|
11 Participants
|
18 Participants
|
11 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Congestive heart failure: No
|
129 Participants
|
55 Participants
|
96 Participants
|
38 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Congestive heart failure: Yes
|
63 Participants
|
21 Participants
|
70 Participants
|
28 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Peripheral vascular disease: No
|
172 Participants
|
70 Participants
|
151 Participants
|
59 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Peripheral vascular disease: Yes
|
20 Participants
|
5 Participants
|
15 Participants
|
7 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Cerebrovascular disease: No
|
153 Participants
|
63 Participants
|
133 Participants
|
57 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Cerebrovascular disease: Yes
|
39 Participants
|
13 Participants
|
33 Participants
|
9 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Dementia: No
|
188 Participants
|
72 Participants
|
153 Participants
|
60 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Dementia: Yes
|
4 Participants
|
4 Participants
|
13 Participants
|
6 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
COPD: No
|
161 Participants
|
66 Participants
|
141 Participants
|
54 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
COPD: Yes
|
31 Participants
|
10 Participants
|
24 Participants
|
12 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Connective tissue disease: No
|
189 Participants
|
76 Participants
|
164 Participants
|
66 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Connective tissue disease: Yes
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Peptic ulcer disease: No
|
187 Participants
|
74 Participants
|
156 Participants
|
65 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Peptic ulcer disease: Yes
|
5 Participants
|
2 Participants
|
10 Participants
|
1 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Liver disease: No
|
190 Participants
|
74 Participants
|
161 Participants
|
65 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Liver disease: Mild
|
2 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Liver disease: Moderate to severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Diabetes mellitus: No
|
135 Participants
|
51 Participants
|
113 Participants
|
47 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Diabetes mellitus: End-organ damage
|
9 Participants
|
7 Participants
|
17 Participants
|
8 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Hemiplegia: No
|
191 Participants
|
76 Participants
|
164 Participants
|
62 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Hemiplegia: Yes
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Moderate to severe renal disease: No
|
166 Participants
|
64 Participants
|
130 Participants
|
48 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Moderate to severe renal disease: Yes
|
26 Participants
|
12 Participants
|
36 Participants
|
18 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Solid tumor: No
|
178 Participants
|
69 Participants
|
148 Participants
|
57 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Solid tumor: Localized
|
13 Participants
|
7 Participants
|
16 Participants
|
7 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Solid tumor: Metastatic
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Leukaemia: No
|
192 Participants
|
76 Participants
|
166 Participants
|
66 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Leukaemia: Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Lymphoma: No
|
192 Participants
|
74 Participants
|
165 Participants
|
65 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Lymphoma: Yes
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
AIDS: No
|
192 Participants
|
76 Participants
|
165 Participants
|
66 Participants
|
|
Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
AIDS: Yes
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Reported is the number of patients in each category of: * Any history of thromboembolic events * Transient Ischemic Attack (TIA) * Ischemic stroke * Haemorrhagic stroke * Embolism systemic * Deep vein thrombosis * Pulmonary embolism. Any history of thromboembolic events, Transient Ischemic Attack (TIA), ischemic stroke, haemorrhagic stroke, embolism systemic, deep vein thrombosis and pulmonary embolism were categorized in the following two categories: * No * Yes.
Outcome measures
| Measure |
Sex: Male
n=192 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=76 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=166 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=66 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Any history of thromboembolic events · No
|
153 Participants
|
53 Participants
|
120 Participants
|
48 Participants
|
|
Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Any history of thromboembolic events · Yes
|
39 Participants
|
23 Participants
|
46 Participants
|
18 Participants
|
|
Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Transient Ischemic Attack (TIA) · No
|
180 Participants
|
66 Participants
|
155 Participants
|
64 Participants
|
|
Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Transient Ischemic Attack (TIA) · Yes
|
10 Participants
|
9 Participants
|
8 Participants
|
2 Participants
|
|
Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Ischemic stroke · No
|
173 Participants
|
65 Participants
|
146 Participants
|
60 Participants
|
|
Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Ischemic stroke · Yes
|
19 Participants
|
7 Participants
|
20 Participants
|
5 Participants
|
|
Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Haemorrhagic stroke · No
|
189 Participants
|
73 Participants
|
163 Participants
|
65 Participants
|
|
Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Haemorrhagic stroke · Yes
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Embolism systemic · No
|
191 Participants
|
73 Participants
|
164 Participants
|
63 Participants
|
|
Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Embolism systemic · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Deep vein thrombosis · No
|
190 Participants
|
71 Participants
|
162 Participants
|
65 Participants
|
|
Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Deep vein thrombosis · Yes
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Pulmonary embolism · No
|
190 Participants
|
73 Participants
|
161 Participants
|
64 Participants
|
|
Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Pulmonary embolism · Yes
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Number of patients in each category of stable angina, unstable angina, myocardial infarction with ST segment elevation and myocardial infarction without ST segment elevation according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. Stable angina, unstable angina, myocardial infarction with ST segment elevation myocardial infarction without ST segment elevation were categorized in the following 2 categories: * Yes; * No.
Outcome measures
| Measure |
Sex: Male
n=192 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=76 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=166 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=66 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients in Each Category of Stable Angina, Unstable Angina, Myocardial Infarction With ST Segment Elevation and Myocardial Infarction Without ST Segment Elevation According to Current NOAC Type
Unstable angina · Yes
|
1 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
|
Number of Patients in Each Category of Stable Angina, Unstable Angina, Myocardial Infarction With ST Segment Elevation and Myocardial Infarction Without ST Segment Elevation According to Current NOAC Type
Myocardial infarction with ST segment elevation · No
|
183 Participants
|
65 Participants
|
153 Participants
|
62 Participants
|
|
Number of Patients in Each Category of Stable Angina, Unstable Angina, Myocardial Infarction With ST Segment Elevation and Myocardial Infarction Without ST Segment Elevation According to Current NOAC Type
Stable angina · No
|
187 Participants
|
73 Participants
|
161 Participants
|
64 Participants
|
|
Number of Patients in Each Category of Stable Angina, Unstable Angina, Myocardial Infarction With ST Segment Elevation and Myocardial Infarction Without ST Segment Elevation According to Current NOAC Type
Stable angina · Yes
|
4 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Patients in Each Category of Stable Angina, Unstable Angina, Myocardial Infarction With ST Segment Elevation and Myocardial Infarction Without ST Segment Elevation According to Current NOAC Type
Unstable angina · No
|
190 Participants
|
72 Participants
|
158 Participants
|
64 Participants
|
|
Number of Patients in Each Category of Stable Angina, Unstable Angina, Myocardial Infarction With ST Segment Elevation and Myocardial Infarction Without ST Segment Elevation According to Current NOAC Type
Myocardial infarction with ST segment elevation · Yes
|
8 Participants
|
8 Participants
|
11 Participants
|
3 Participants
|
|
Number of Patients in Each Category of Stable Angina, Unstable Angina, Myocardial Infarction With ST Segment Elevation and Myocardial Infarction Without ST Segment Elevation According to Current NOAC Type
Myocardial infarction without ST segment elevation · No
|
183 Participants
|
69 Participants
|
156 Participants
|
57 Participants
|
|
Number of Patients in Each Category of Stable Angina, Unstable Angina, Myocardial Infarction With ST Segment Elevation and Myocardial Infarction Without ST Segment Elevation According to Current NOAC Type
Myocardial infarction without ST segment elevation · Yes
|
8 Participants
|
4 Participants
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Total number of thromboembolic events, number of each type of thromboembolic events, number of stable and unstable anginas, and number of ST and non-ST myocardial infarction according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported.
Outcome measures
| Measure |
Sex: Male
n=192 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=76 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=166 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=66 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Total Number of Thromboembolic Events, Number of Each Type of Thromboembolic Events, Number of Stable and Unstable Anginas, and Number of ST and Non-ST Myocardial Infarction According to Current NOAC Type
Total number of thromboembolic events
|
0.29 events
Standard Deviation 0.66
|
0.54 events
Standard Deviation 1.24
|
0.49 events
Standard Deviation 1.19
|
0.36 events
Standard Deviation 0.69
|
|
Total Number of Thromboembolic Events, Number of Each Type of Thromboembolic Events, Number of Stable and Unstable Anginas, and Number of ST and Non-ST Myocardial Infarction According to Current NOAC Type
Number of Transient Ischemic Attack (TIA)
|
0.05 events
Standard Deviation 0.22
|
0.19 events
Standard Deviation 0.63
|
0.06 events
Standard Deviation 0.25
|
0.03 events
Standard Deviation 0.17
|
|
Total Number of Thromboembolic Events, Number of Each Type of Thromboembolic Events, Number of Stable and Unstable Anginas, and Number of ST and Non-ST Myocardial Infarction According to Current NOAC Type
Number of ischemic strokes
|
0.10 events
Standard Deviation 0.30
|
0.10 events
Standard Deviation 0.30
|
0.13 events
Standard Deviation 0.35
|
0.09 events
Standard Deviation 0.34
|
|
Total Number of Thromboembolic Events, Number of Each Type of Thromboembolic Events, Number of Stable and Unstable Anginas, and Number of ST and Non-ST Myocardial Infarction According to Current NOAC Type
Number of haemorrhagic strokes
|
0.01 events
Standard Deviation 0.07
|
0.00 events
Standard Deviation 0.00
|
0.01 events
Standard Deviation 0.08
|
0.00 events
Standard Deviation 0.00
|
|
Total Number of Thromboembolic Events, Number of Each Type of Thromboembolic Events, Number of Stable and Unstable Anginas, and Number of ST and Non-ST Myocardial Infarction According to Current NOAC Type
Number of embolism systemic
|
0.00 events
Standard Deviation 0.00
|
0.00 events
Standard Deviation 0.00
|
0.00 events
Standard Deviation 0.00
|
0.03 events
Standard Deviation 0.17
|
|
Total Number of Thromboembolic Events, Number of Each Type of Thromboembolic Events, Number of Stable and Unstable Anginas, and Number of ST and Non-ST Myocardial Infarction According to Current NOAC Type
Number of deep vein thrombosis
|
0.01 events
Standard Deviation 0.14
|
0.05 events
Standard Deviation 0.37
|
0.01 events
Standard Deviation 0.11
|
0.00 events
Standard Deviation 0.00
|
|
Total Number of Thromboembolic Events, Number of Each Type of Thromboembolic Events, Number of Stable and Unstable Anginas, and Number of ST and Non-ST Myocardial Infarction According to Current NOAC Type
Number of pulmonary embolisms
|
0.01 events
Standard Deviation 0.07
|
0.01 events
Standard Deviation 0.12
|
0.02 events
Standard Deviation 0.13
|
0.02 events
Standard Deviation 0.12
|
|
Total Number of Thromboembolic Events, Number of Each Type of Thromboembolic Events, Number of Stable and Unstable Anginas, and Number of ST and Non-ST Myocardial Infarction According to Current NOAC Type
Number of stable anginas
|
0.02 events
Standard Deviation 0.14
|
0.00 events
Standard Deviation 0.00
|
0.02 events
Standard Deviation 0.15
|
0.02 events
Standard Deviation 0.12
|
|
Total Number of Thromboembolic Events, Number of Each Type of Thromboembolic Events, Number of Stable and Unstable Anginas, and Number of ST and Non-ST Myocardial Infarction According to Current NOAC Type
Number of unstable anginas
|
0.01 events
Standard Deviation 0.07
|
0.01 events
Standard Deviation 0.12
|
0.12 events
Standard Deviation 0.74
|
0.02 events
Standard Deviation 0.12
|
|
Total Number of Thromboembolic Events, Number of Each Type of Thromboembolic Events, Number of Stable and Unstable Anginas, and Number of ST and Non-ST Myocardial Infarction According to Current NOAC Type
Number of myocardial infarctions with ST segment elevation
|
0.04 events
Standard Deviation 0.20
|
0.12 events
Standard Deviation 0.37
|
0.07 events
Standard Deviation 0.25
|
0.05 events
Standard Deviation 0.21
|
|
Total Number of Thromboembolic Events, Number of Each Type of Thromboembolic Events, Number of Stable and Unstable Anginas, and Number of ST and Non-ST Myocardial Infarction According to Current NOAC Type
Number of myocardial infarctions without ST segment elevation
|
0.05 events
Standard Deviation 0.24
|
0.07 events
Standard Deviation 0.30
|
0.06 events
Standard Deviation 0.29
|
0.12 events
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Number of patients with (category Yes) and without (category No) any history of bleeding events and number of patients in each category of the following bleeding types is reported: * Intracranial * Digestive * Genitourinary * Gingival * Nasal * Pulmonary * Articular-muscular * Conjunctival. Intracranial, digestive, genitourinary, gingival, nasal, pulmonary, articular-muscular, conjunctival were categorized in two categories: * No * Yes.
Outcome measures
| Measure |
Sex: Male
n=192 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=76 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=166 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=66 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Any history of bleeding events · No
|
177 Participants
|
68 Participants
|
120 Participants
|
56 Participants
|
|
Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Any history of bleeding events · Yes
|
14 Participants
|
8 Participants
|
46 Participants
|
9 Participants
|
|
Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Intracranial · No
|
188 Participants
|
74 Participants
|
158 Participants
|
64 Participants
|
|
Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Intracranial · Yes
|
3 Participants
|
2 Participants
|
7 Participants
|
1 Participants
|
|
Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Digestive · No
|
183 Participants
|
73 Participants
|
140 Participants
|
62 Participants
|
|
Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Digestive · Yes
|
8 Participants
|
3 Participants
|
26 Participants
|
3 Participants
|
|
Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Genitourinary · No
|
189 Participants
|
76 Participants
|
158 Participants
|
63 Participants
|
|
Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Genitourinary · Yes
|
2 Participants
|
0 Participants
|
6 Participants
|
2 Participants
|
|
Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Gingival · No
|
191 Participants
|
75 Participants
|
163 Participants
|
64 Participants
|
|
Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Gingival · Yes
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Nasal · No
|
191 Participants
|
76 Participants
|
157 Participants
|
62 Participants
|
|
Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Nasal · Yes
|
0 Participants
|
0 Participants
|
8 Participants
|
3 Participants
|
|
Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Pulmonary · No
|
191 Participants
|
76 Participants
|
162 Participants
|
64 Participants
|
|
Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Pulmonary · Yes
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Articular-muscular · No
|
189 Participants
|
76 Participants
|
162 Participants
|
65 Participants
|
|
Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Articular-muscular · Yes
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Conjunctival · No
|
191 Participants
|
73 Participants
|
164 Participants
|
64 Participants
|
|
Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Conjunctival · Yes
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Total number of bleeding events and number of bleeding events for the following bleeding types is reported: * Intracranial * Digestive * Genitourinary * Gingival * Nasal * Pulmonary * Articular-muscular * Conjunctival.
Outcome measures
| Measure |
Sex: Male
n=192 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=76 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=166 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=66 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Total Number of Bleeding Events and Number of Each Type of Bleeding Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Number of nasal events
|
0.00 events
Standard Deviation 0.00
|
0.00 events
Standard Deviation 0.00
|
0.07 events
Standard Deviation 0.36
|
0.08 events
Standard Deviation 0.37
|
|
Total Number of Bleeding Events and Number of Each Type of Bleeding Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Number of pulmonary events
|
0.00 events
Standard Deviation 0.00
|
0.00 events
Standard Deviation 0.00
|
0.02 events
Standard Deviation 0.19
|
0.02 events
Standard Deviation 0.12
|
|
Total Number of Bleeding Events and Number of Each Type of Bleeding Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Number of articular-muscular events
|
0.01 events
Standard Deviation 0.10
|
0.00 events
Standard Deviation 0.00
|
0.02 events
Standard Deviation 0.19
|
0.00 events
Standard Deviation 0.00
|
|
Total Number of Bleeding Events and Number of Each Type of Bleeding Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Number of conjunctival events
|
0.00 events
Standard Deviation 0.00
|
0.04 events
Standard Deviation 0.20
|
0.01 events
Standard Deviation 0.08
|
0.02 events
Standard Deviation 0.12
|
|
Total Number of Bleeding Events and Number of Each Type of Bleeding Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Number of total bleeding events
|
0.10 events
Standard Deviation 0.42
|
0.12 events
Standard Deviation 0.36
|
0.48 events
Standard Deviation 1.01
|
0.28 events
Standard Deviation 0.82
|
|
Total Number of Bleeding Events and Number of Each Type of Bleeding Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Number of intracranial events
|
0.02 events
Standard Deviation 0.12
|
0.03 events
Standard Deviation 0.16
|
0.04 events
Standard Deviation 0.20
|
0.02 events
Standard Deviation 0.12
|
|
Total Number of Bleeding Events and Number of Each Type of Bleeding Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Number of digestive events
|
0.06 events
Standard Deviation 0.36
|
0.04 events
Standard Deviation 0.20
|
0.27 events
Standard Deviation 0.80
|
0.06 events
Standard Deviation 0.30
|
|
Total Number of Bleeding Events and Number of Each Type of Bleeding Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Number of genitourinary events
|
0.01 events
Standard Deviation 0.10
|
0.00 events
Standard Deviation 0.00
|
0.04 events
Standard Deviation 0.19
|
0.06 events
Standard Deviation 0.35
|
|
Total Number of Bleeding Events and Number of Each Type of Bleeding Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Number of gingival events
|
0.00 events
Standard Deviation 0.00
|
0.01 events
Standard Deviation 0.11
|
0.01 events
Standard Deviation 0.11
|
0.03 events
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
The Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) score is a clinical prediction rule to estimate the risk of stroke in patients with Atrial Fibrillation (AF); it is frequently used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.
Outcome measures
| Measure |
Sex: Male
n=192 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=76 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=166 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=66 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
CHA2DS2-VASc Total Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
|
4.05 score on a scale
Standard Deviation 1.34
|
4.43 score on a scale
Standard Deviation 1.33
|
4.63 score on a scale
Standard Deviation 1.36
|
4.32 score on a scale
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
The Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) total score was categorized in three categories, according to the risk of stroke: * Low risk (score 0 in male; score 1 in female) * Moderate risk (score 1 in male; score 2 in female) * High risk (score ≥2 in male; score ≥3 in female)
Outcome measures
| Measure |
Sex: Male
n=192 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=76 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=166 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=66 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients on Each Category of CHA2DS2-VASc Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Low risk
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients on Each Category of CHA2DS2-VASc Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Moderate risk
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients on Each Category of CHA2DS2-VASc Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
High risk
|
192 Participants
|
76 Participants
|
166 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile International Normalized Ratio (INR), Elderly (\>65 years), Drugs and Alcohol (HAS-BLED) score may range from 0 to 9 with 0 being the best outcome. The high scores indicate a greater risk of bleeding and a low score corresponds to a lower risk of bleeding.
Outcome measures
| Measure |
Sex: Male
n=192 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=76 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=166 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=66 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
HAS-BLED Total Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
|
1.99 score on a scale
Standard Deviation 0.82
|
1.64 score on a scale
Standard Deviation 0.78
|
2.01 score on a scale
Standard Deviation 0.92
|
2.06 score on a scale
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol (HAS-BLED) total score was categorized in three categories according to the bleeding risk: * Low risk (score 0) * Intermediate risk (score 1-2) * High risk (score ≥3)
Outcome measures
| Measure |
Sex: Male
n=192 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=76 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=166 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=66 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients in Each Category of HAS-BLED Score According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Low risk
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of HAS-BLED Score According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Intermediate risk
|
147 Participants
|
64 Participants
|
118 Participants
|
48 Participants
|
|
Number of Patients in Each Category of HAS-BLED Score According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
High risk
|
45 Participants
|
12 Participants
|
48 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Number of patients in each category (No;Yes) of any concomitant treatments to NOAC and number of patients in each category (No; Yes) for each concomitant treatment to NOAC at study visit according to current NOAC type is reported. The concomitant treatment to non-vitamin K antagonist oral anticoagulant (NOAC) were the following: * Angiotensin-Receptor Blockers (ARB) or Angiotensin Converting Enzyme inhibitors (ACE) inhibitor * Beta-blocker * Calcium channel blockers * Diuretics * Amiodarone * Statin * Proton pump inhibitor * H2-receptor antagonist * Digoxin * NSAIDs (Nonsteroidal Anti-Inflammatory Drugs) * Dronedarone * Ketoconazole * Cyclosporine * Itraconazole * Other antiarrhythmics
Outcome measures
| Measure |
Sex: Male
n=192 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=76 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=166 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=66 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Any concomitant treatments to NOAC · No
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Any concomitant treatments to NOAC · Yes
|
192 Participants
|
76 Participants
|
166 Participants
|
66 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
ARB or ACE inhibitor · No
|
54 Participants
|
20 Participants
|
57 Participants
|
18 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
ARB or ACE inhibitor · Yes
|
138 Participants
|
56 Participants
|
109 Participants
|
48 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Beta-blocker · No
|
82 Participants
|
27 Participants
|
54 Participants
|
21 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Beta-blocker · Yes
|
110 Participants
|
49 Participants
|
112 Participants
|
45 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Calcium channel blockers · No
|
154 Participants
|
53 Participants
|
136 Participants
|
47 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Calcium channel blockers · Yes
|
38 Participants
|
23 Participants
|
30 Participants
|
19 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Diuretics · No
|
87 Participants
|
32 Participants
|
56 Participants
|
19 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Diuretics · Yes
|
105 Participants
|
44 Participants
|
110 Participants
|
47 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Amiodarone · No
|
174 Participants
|
67 Participants
|
146 Participants
|
62 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Amiodarone · Yes
|
18 Participants
|
9 Participants
|
20 Participants
|
4 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Statin · No
|
83 Participants
|
34 Participants
|
77 Participants
|
18 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Statin · Yes
|
109 Participants
|
42 Participants
|
89 Participants
|
48 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Proton pump inhibitor · No
|
89 Participants
|
29 Participants
|
58 Participants
|
17 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Proton pump inhibitor · Yes
|
103 Participants
|
47 Participants
|
108 Participants
|
49 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
H2-receptor antagonist · No
|
191 Participants
|
75 Participants
|
162 Participants
|
65 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
H2-receptor antagonist · Yes
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Digoxin · No
|
168 Participants
|
71 Participants
|
153 Participants
|
57 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Digoxin · Yes
|
24 Participants
|
5 Participants
|
13 Participants
|
9 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
NSAIDs · No
|
180 Participants
|
72 Participants
|
155 Participants
|
61 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
NSAIDs · Yes
|
12 Participants
|
4 Participants
|
11 Participants
|
5 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Dronedarone · No
|
192 Participants
|
76 Participants
|
163 Participants
|
66 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Dronedarone · Yes
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Ketoconazole · No
|
192 Participants
|
76 Participants
|
166 Participants
|
66 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Ketoconazole · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Cyclosporine · No
|
192 Participants
|
76 Participants
|
166 Participants
|
66 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Cyclosporine · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Itraconazole · No
|
192 Participants
|
76 Participants
|
166 Participants
|
66 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Itraconazole · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Other antiarrhythmics · No
|
188 Participants
|
73 Participants
|
160 Participants
|
65 Participants
|
|
Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Other antiarrhythmics · Yes
|
4 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Number of patients in each category of previous Vitamin K Antagonists (VKA) treatment according to duration since the first non-vitamin K antagonist oral anticoagulant (NOAC) initiation is reported. Previous VKA treatment was categorized in 2 categories: * No; * Yes.
Outcome measures
| Measure |
Sex: Male
n=39 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=461 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients in Each Category of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
No
|
26 Participants
|
187 Participants
|
—
|
—
|
|
Number of Patients in Each Category of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Yes
|
13 Participants
|
274 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Participants of FAS who previously received VKA treatment. One patient received acenocoumarol and warfarin during the study, so the total percentage is not 100%.
Number of patients treated previously (before they were treated with non-vitamin K antagonist oral anticoagulant (NOAC)) with the Vitamin K Antagonists (VKA) acenocoumarol and number of patients treated previously with the VKA warfarin according to duration since the first NOAC initiation is reported.
Outcome measures
| Measure |
Sex: Male
n=13 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=274 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients Treated Previously With the VKA Acenocoumarol and Number of Patients Treated Previously With the VKA Warfarin According to Duration Since the First NOAC Initiation
Acenocoumarol
|
13 Participants
|
263 Participants
|
—
|
—
|
|
Number of Patients Treated Previously With the VKA Acenocoumarol and Number of Patients Treated Previously With the VKA Warfarin According to Duration Since the First NOAC Initiation
Warfarin
|
0 Participants
|
12 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Duration of treatment (in years) is reported for: * All patients treated previously with Vitamin K Antagonists (VKA) (row:All patients treated previously with VKA) * Patients treated only with the VKA warfarin (row: Warfarin patients) * Patients treated only with the VKA acenocoumarol (row: Acenocoumarol patients)
Outcome measures
| Measure |
Sex: Male
n=13 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=274 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Duration of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Acenocoumarol patients
|
3.65 Years
Standard Deviation 3.85
|
3.88 Years
Standard Deviation 4.14
|
—
|
—
|
|
Duration of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Warfarin patients
|
—
|
3.35 Years
Standard Deviation 1.94
|
—
|
—
|
|
Duration of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
All patients treated previously with VKA
|
3.65 Years
Standard Deviation 3.85
|
3.87 Years
Standard Deviation 4.07
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Duration (in years) since non-valvular atrial fibrillation (NVAF) diagnosis until first NOAC initiation according to duration since the first NOAC initiation is reported for: * All patients * Patients treated previously with VKA * Patients treated only with NOAC as anticoagulant (AC)
Outcome measures
| Measure |
Sex: Male
n=39 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=460 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Duration Since Non-valvular Atrial Fibrillation (NVAF) Diagnosis Until First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation According to Duration Since the First NOAC Initiation
All patients
|
1.62 Years
Standard Deviation 2.77
|
3.27 Years
Standard Deviation 4.95
|
—
|
—
|
|
Duration Since Non-valvular Atrial Fibrillation (NVAF) Diagnosis Until First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation According to Duration Since the First NOAC Initiation
Patients treated previously with VKA
|
3.71 Years
Standard Deviation 3.70
|
4.84 Years
Standard Deviation 4.79
|
—
|
—
|
|
Duration Since Non-valvular Atrial Fibrillation (NVAF) Diagnosis Until First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation According to Duration Since the First NOAC Initiation
Patients treated with NOAC as first AC
|
0.58 Years
Standard Deviation 1.30
|
0.99 Years
Standard Deviation 4.27
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as first NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as first NOAC according to duration since the first NOAC initiation is reported.
Outcome measures
| Measure |
Sex: Male
n=39 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=461 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation
First NOAC received: Dabigatran ( 110 mg BID and 150 mg BID patients)
|
23 Participants
|
174 Participants
|
—
|
—
|
|
First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation
First NOAC received: Rivaroxaban (15 mg QD and 20 mg QD patients)
|
2 Participants
|
81 Participants
|
—
|
—
|
|
First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation
First NOAC received: Apixaban (2.5 mg BID and 5 mg BID patients)
|
9 Participants
|
143 Participants
|
—
|
—
|
|
First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation
First NOAC received: Edoxaban (30 mg QD and 60 mg QD patients)
|
5 Participants
|
63 Participants
|
—
|
—
|
|
First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation
First NOAC dose: Dabigatran 110 mg BID
|
6 Participants
|
88 Participants
|
—
|
—
|
|
First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation
First NOAC dose: Dabigatran 150 mg BID
|
17 Participants
|
86 Participants
|
—
|
—
|
|
First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation
First NOAC dose: Rivaroxaban 15 mg QD
|
0 Participants
|
30 Participants
|
—
|
—
|
|
First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation
First NOAC dose: Rivaroxaban 20 mg QD
|
2 Participants
|
51 Participants
|
—
|
—
|
|
First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation
First NOAC dose: Apixaban 2.5 mg BID
|
4 Participants
|
53 Participants
|
—
|
—
|
|
First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation
First NOAC dose: Apixaban 5 mg BID
|
5 Participants
|
90 Participants
|
—
|
—
|
|
First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation
First NOAC dose: Edoxaban 30 mg QD
|
4 Participants
|
26 Participants
|
—
|
—
|
|
First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation
First NOAC dose: Edoxaban 60 mg QD
|
1 Participants
|
37 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Number of patients who changed (increased and decreased) and did not change the first non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported.
Outcome measures
| Measure |
Sex: Male
n=39 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=461 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients Who Changed (Increased and Decreased) and Did Not Change the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation
No
|
39 Participants
|
427 Participants
|
—
|
—
|
|
Number of Patients Who Changed (Increased and Decreased) and Did Not Change the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation
Yes (increase)
|
0 Participants
|
8 Participants
|
—
|
—
|
|
Number of Patients Who Changed (Increased and Decreased) and Did Not Change the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation
Yes (decrease)
|
0 Participants
|
26 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Treatment duration (in years) is reported for: * Patients who stopped first NOAC treatment; * Patients who did not stop the first NOAC treatment.
Outcome measures
| Measure |
Sex: Male
n=39 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=461 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation
Patients who stopped first NOAC treatment
|
0.01 Years
|
1.60 Years
Standard Deviation 1.61
|
—
|
—
|
|
First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation
Patients who did not stop the first NOAC treatment
|
0.30 Years
Standard Deviation 0.03
|
2.38 Years
Standard Deviation 1.93
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Only patients who stopped first NOAC treatment.
Reason for first NOAC treatment discontinuation was categorized in four categories: * Lack of effectiveness * Investigator's decision * Patient's decision * Adverse event
Outcome measures
| Measure |
Sex: Male
n=1 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=42 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation
Lack of effectiveness
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation
Investigator's decision
|
0 Participants
|
15 Participants
|
—
|
—
|
|
Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation
Patient's decision
|
0 Participants
|
7 Participants
|
—
|
—
|
|
Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation
Adverse event
|
1 Participants
|
19 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Only patients who changed dose in first NOAC treatment.
Reason for first NOAC treatment change was categorized in four categories: * Lack of effectiveness * Investigator's decision * Patient's decision * Adverse event
Outcome measures
| Measure |
Sex: Male
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=34 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation
Lack of effectiveness
|
—
|
2 Participants
|
—
|
—
|
|
Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation
Investigator's decision
|
—
|
24 Participants
|
—
|
—
|
|
Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation
Patient's decision
|
—
|
0 Participants
|
—
|
—
|
|
Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation
Adverse event
|
—
|
8 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Number of switches to a new non-vitamin K antagonist oral anticoagulant (NOAC) per patient according to duration since the first NOAC initiation is reported.
Outcome measures
| Measure |
Sex: Male
n=39 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=461 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation
|
0.03 switches per patient
Standard Deviation 0.16
|
0.10 switches per patient
Standard Deviation 0.35
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Number of patients based on the number of switches to a new NOAC per patient according to duration since the first NOAC initiation is reported. Number of switches to a new NOAC was categorized in 3 categories: * 0 switches * 1 switch * 2 switches.
Outcome measures
| Measure |
Sex: Male
n=39 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=461 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients in Each Category of Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation
0 switches
|
38 Participants
|
419 Participants
|
—
|
—
|
|
Number of Patients in Each Category of Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation
1 switch
|
1 Participants
|
36 Participants
|
—
|
—
|
|
Number of Patients in Each Category of Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation
2 switches
|
0 Participants
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Participants of FAS who switched to a new NOAC.
Total number of switches according to duration since the first NOAC initiation is reported.
Outcome measures
| Measure |
Sex: Male
n=1 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=48 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Dabigatran to Rivaroxaban
|
0 Switches to a new NOAC
|
3 Switches to a new NOAC
|
—
|
—
|
|
Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Dabigatran to Apixaban
|
0 Switches to a new NOAC
|
9 Switches to a new NOAC
|
—
|
—
|
|
Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Dabigatran to Edoxaban
|
0 Switches to a new NOAC
|
2 Switches to a new NOAC
|
—
|
—
|
|
Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Rivaroxaban to Dabigatran
|
0 Switches to a new NOAC
|
0 Switches to a new NOAC
|
—
|
—
|
|
Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Rivaroxaban to Apixaban
|
1 Switches to a new NOAC
|
10 Switches to a new NOAC
|
—
|
—
|
|
Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Rivaroxaban to Edoxaban
|
0 Switches to a new NOAC
|
2 Switches to a new NOAC
|
—
|
—
|
|
Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Apixaban to Dabigatran
|
0 Switches to a new NOAC
|
5 Switches to a new NOAC
|
—
|
—
|
|
Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Apixaban to Rivaroxaban
|
0 Switches to a new NOAC
|
3 Switches to a new NOAC
|
—
|
—
|
|
Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Apixaban to Edoxaban
|
0 Switches to a new NOAC
|
4 Switches to a new NOAC
|
—
|
—
|
|
Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Edoxaban to Dabigatran
|
0 Switches to a new NOAC
|
4 Switches to a new NOAC
|
—
|
—
|
|
Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Edoxaban to Rivaroxaban
|
0 Switches to a new NOAC
|
0 Switches to a new NOAC
|
—
|
—
|
|
Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Edoxaban to Apixaban
|
0 Switches to a new NOAC
|
6 Switches to a new NOAC
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Participants of FAS who switched to a new NOAC.
Reason for switch was categorized in four categories: * Lack of effectiveness * Investigator's decision * Patient's decision * Adverse event
Outcome measures
| Measure |
Sex: Male
n=1 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=48 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Switches in Each Category of Reason for Switch According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Lack of effectiveness
|
0 Switches to another NOAC
|
1 Switches to another NOAC
|
—
|
—
|
|
Number of Switches in Each Category of Reason for Switch According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Investigator's decision
|
0 Switches to another NOAC
|
17 Switches to another NOAC
|
—
|
—
|
|
Number of Switches in Each Category of Reason for Switch According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Patient's decision
|
0 Switches to another NOAC
|
7 Switches to another NOAC
|
—
|
—
|
|
Number of Switches in Each Category of Reason for Switch According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Adverse event
|
1 Switches to another NOAC
|
23 Switches to another NOAC
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Number of patients who stopped the first NOAC treatment and switched to a second NOAC treatment.
Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as second NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as second NOAC according to duration since the first NOAC initiation is reported.
Outcome measures
| Measure |
Sex: Male
n=1 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=42 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation
Second NOAC received: Dabigatran (110 mg BID and 150 mg BID patients)
|
0 Participants
|
8 Participants
|
—
|
—
|
|
Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation
Second NOAC received: Rivaroxaban (15 mg QD and 20 mg QD patients)
|
0 Participants
|
5 Participants
|
—
|
—
|
|
Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation
Second NOAC received: Apixaban (2.5 mg BID and 5 mg BID patients)
|
1 Participants
|
21 Participants
|
—
|
—
|
|
Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation
Second NOAC received: Edoxaban (30 mg QD and 60 mg QD patients)
|
0 Participants
|
8 Participants
|
—
|
—
|
|
Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation
Second NOAC dose: Dabigatran 110 mg BID
|
—
|
6 Participants
|
—
|
—
|
|
Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation
Second NOAC dose: Dabigatran 150 mg BID
|
—
|
2 Participants
|
—
|
—
|
|
Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation
Second NOAC dose: Rivaroxaban 15 mg QD
|
—
|
3 Participants
|
—
|
—
|
|
Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation
Second NOAC dose: Rivaroxaban 20 mg QD
|
—
|
2 Participants
|
—
|
—
|
|
Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation
Second NOAC dose: Apixaban 2.5 mg BID
|
0 Participants
|
13 Participants
|
—
|
—
|
|
Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation
Second NOAC dose: Apixaban 5 mg BID
|
1 Participants
|
8 Participants
|
—
|
—
|
|
Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation
Second NOAC dose: Edoxaban 30 mg QD
|
—
|
3 Participants
|
—
|
—
|
|
Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation
Second NOAC dose: Edoxaban 60 mg QD
|
—
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Participants of FAS who stopped the first NOAC treatment and switched to a second NOAC treatment.
Number of patients who changed (increased or decreased) and did not change the second non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported.
Outcome measures
| Measure |
Sex: Male
n=1 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=42 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients Who Changed (Increased or Decreased) and Did Not Change the Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation
No
|
1 Participants
|
40 Participants
|
—
|
—
|
|
Number of Patients Who Changed (Increased or Decreased) and Did Not Change the Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation
Yes (increase)
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients Who Changed (Increased or Decreased) and Did Not Change the Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation
Yes (decrease)
|
0 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Participants of FAS who stopped second NOAC treatment.
Second NOAC treatment duration (in years) according to duration since the first NOAC initiation is reported.
Outcome measures
| Measure |
Sex: Male
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=6 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation
|
—
|
0.49 Years
Standard Deviation 0.39
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Participants of FAS who stopped second NOAC treatment.
Reason for second non-vitamin K antagonist oral anticoagulant (NOAC) treatment discontinuation was categorized in four categories: * Lack of effectiveness * Investigator's decision * Patient's decision * Adverse event
Outcome measures
| Measure |
Sex: Male
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=6 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation
Lack of effectiveness
|
—
|
0 Participants
|
—
|
—
|
|
Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation
Investigator's decision
|
—
|
2 Participants
|
—
|
—
|
|
Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation
Patient's decision
|
—
|
0 Participants
|
—
|
—
|
|
Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation
Adverse event
|
—
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Participants of FAS who changed dose in second NOAC treatment.
Reason for second NOAC treatment change was categorized in four categories: * Lack of effectiveness * Investigator's decision * Patient's decision * Adverse event
Outcome measures
| Measure |
Sex: Male
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=2 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation
Lack of effectiveness
|
—
|
0 Participants
|
—
|
—
|
|
Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation
Investigator's decision
|
—
|
2 Participants
|
—
|
—
|
|
Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation
Patient's decision
|
—
|
0 Participants
|
—
|
—
|
|
Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation
Adverse event
|
—
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Participants of FAS who stopped second NOAC treatment.
Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as third NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as third NOAC according to duration since the first NOAC initiation is reported.
Outcome measures
| Measure |
Sex: Male
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=6 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Third NOAC Dose According to Duration Since the First NOAC Initiation
Third NOAC received: Dabigatran
|
—
|
1 Participants
|
—
|
—
|
|
Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Third NOAC Dose According to Duration Since the First NOAC Initiation
Third NOAC received: Rivaroxaban
|
—
|
1 Participants
|
—
|
—
|
|
Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Third NOAC Dose According to Duration Since the First NOAC Initiation
Third NOAC received: Apixaban
|
—
|
4 Participants
|
—
|
—
|
|
Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Third NOAC Dose According to Duration Since the First NOAC Initiation
Third NOAC received:Edoxaban
|
—
|
0 Participants
|
—
|
—
|
|
Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Third NOAC Dose According to Duration Since the First NOAC Initiation
Third NOAC dose: Dabigatran 110 mg BID
|
—
|
1 Participants
|
—
|
—
|
|
Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Third NOAC Dose According to Duration Since the First NOAC Initiation
Third NOAC dose: Dabigatran 150 mg BID
|
—
|
0 Participants
|
—
|
—
|
|
Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Third NOAC Dose According to Duration Since the First NOAC Initiation
Third NOAC dose: Rivaroxaban 15 mg QD
|
—
|
1 Participants
|
—
|
—
|
|
Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Third NOAC Dose According to Duration Since the First NOAC Initiation
Third NOAC dose: Rivaroxaban 20 mg QD
|
—
|
0 Participants
|
—
|
—
|
|
Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Third NOAC Dose According to Duration Since the First NOAC Initiation
Third NOAC dose: Apixaban 2.5 mg BID
|
—
|
3 Participants
|
—
|
—
|
|
Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Third NOAC Dose According to Duration Since the First NOAC Initiation
Third NOAC dose: Apixaban 5 mg BID
|
—
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Participants of FAS who started third NOAC treatment.
Number of patients who changed (increased and decreased) and did not change the third non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported.
Outcome measures
| Measure |
Sex: Male
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=6 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients Who Changed (Increased and Decreased) and Did Not Change the Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation
No
|
—
|
6 Participants
|
—
|
—
|
|
Number of Patients Who Changed (Increased and Decreased) and Did Not Change the Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation
Yes (increase)
|
—
|
0 Participants
|
—
|
—
|
|
Number of Patients Who Changed (Increased and Decreased) and Did Not Change the Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation
Yes (decrease)
|
—
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Participants of FAS who stopped third NOAC treatment. No patient stopped the third NOAC treatment.
Duration of third NOAC treatment for patients who stopped NOAC treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Participants of FAS who stopped third NOAC treatment. No patient stopped the third NOAC treatment.
Reason for Third NOAC treatment discontinuation was categorized in four categories: * Lack of effectiveness * Investigator's decision * Patient's decision * Adverse event
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Participants of FAS who changed dose in third NOAC treatment. No patients stopped the third NOAC treatment.
Reason for Third NOAC treatment change was categorized in four categories: * Lack of effectiveness * Investigator's decision * Patient's decision * Adverse event
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Duration (in years) in NOAC treatment is reported for: * All patients (patients who received or did not receive VKA) * Patients treated previously with Vitamin K Antagonists (VKA) * Patients treated with NOAC as first anticoagulant
Outcome measures
| Measure |
Sex: Male
n=39 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=461 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Duration (in Years) in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation
All patients
|
0.29 Years
Standard Deviation 0.03
|
2.45 Years
Standard Deviation 1.96
|
—
|
—
|
|
Duration (in Years) in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation
Patients treated previously with VKA
|
0.29 Years
Standard Deviation 0.03
|
2.39 Years
Standard Deviation 1.98
|
—
|
—
|
|
Duration (in Years) in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation
Patients treated with NOAC as first anticoagulant
|
0.29 Years
Standard Deviation 0.03
|
2.54 Years
Standard Deviation 1.94
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Number of patients in each category of total time in non-vitamin K antagonist oral anticoagulant (NOAC) treatment according to duration since the first NOAC initiation is reported. Total time in NOAC treatment was categorized in 4 categories: * \<1 year; * 1-2 years; * 2-3 years; * \>3 years.
Outcome measures
| Measure |
Sex: Male
n=39 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=461 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients in Each Category of Total Time in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation
<1 year
|
39 Participants
|
149 Participants
|
—
|
—
|
|
Number of Patients in Each Category of Total Time in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation
1-2 years
|
0 Participants
|
87 Participants
|
—
|
—
|
|
Number of Patients in Each Category of Total Time in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation
2-3 years
|
0 Participants
|
74 Participants
|
—
|
—
|
|
Number of Patients in Each Category of Total Time in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation
>3 years
|
0 Participants
|
151 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Number of patients for each type of following antiplatelet treatment that the patients ever received is reported: * None (reports the patients who did not receive any antiplatelet treatment) * Acetyl salicylic acid * Clopidogrel * Prasugrel * Ticlopidine * Ticagrelor * Cilostazol * Triflusal * Dipyridamole * Others (other antiplatelet treatment than above mentioned).
Outcome measures
| Measure |
Sex: Male
n=39 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=461 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients for Each Type of Antiplatelet Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
None (no antiplatelet treatment received)
|
35 Participants
|
314 Participants
|
—
|
—
|
|
Number of Patients for Each Type of Antiplatelet Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Acetyl salicylic acid
|
4 Participants
|
124 Participants
|
—
|
—
|
|
Number of Patients for Each Type of Antiplatelet Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Clopidogrel
|
1 Participants
|
43 Participants
|
—
|
—
|
|
Number of Patients for Each Type of Antiplatelet Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Prasugrel
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Patients for Each Type of Antiplatelet Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Ticlopidine
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients for Each Type of Antiplatelet Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Ticagrelor
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients for Each Type of Antiplatelet Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Cilostazol
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients for Each Type of Antiplatelet Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Triflusal
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number of Patients for Each Type of Antiplatelet Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Dipyridamole
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients for Each Type of Antiplatelet Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Others (other antiplatelet treatment than listed above)
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Number of patients for each of the following antiplatelet treatment types at the time of study visit according to duration since the first NOAC initiation is reported: * None (reports the patients who did not receive any antiplatelet treatment) * Acetyl salicylic acid * Clopidogrel * Prasugrel * Ticlopidine * Ticagrelor * Cilostazol * Triflusal * Dipyridamole * Others (other antiplatelet treatment than above mentioned).
Outcome measures
| Measure |
Sex: Male
n=39 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=461 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients for Each Type of Antiplatelet Treatment at the Time of Study Visit According to Duration Since the First NOAC Initiation
None
|
38 Participants
|
444 Participants
|
—
|
—
|
|
Number of Patients for Each Type of Antiplatelet Treatment at the Time of Study Visit According to Duration Since the First NOAC Initiation
Acetyl salicylic acid
|
0 Participants
|
9 Participants
|
—
|
—
|
|
Number of Patients for Each Type of Antiplatelet Treatment at the Time of Study Visit According to Duration Since the First NOAC Initiation
Clopidogrel
|
1 Participants
|
11 Participants
|
—
|
—
|
|
Number of Patients for Each Type of Antiplatelet Treatment at the Time of Study Visit According to Duration Since the First NOAC Initiation
Prasugrel
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients for Each Type of Antiplatelet Treatment at the Time of Study Visit According to Duration Since the First NOAC Initiation
Ticlopidine
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients for Each Type of Antiplatelet Treatment at the Time of Study Visit According to Duration Since the First NOAC Initiation
Ticagrelor
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Patients for Each Type of Antiplatelet Treatment at the Time of Study Visit According to Duration Since the First NOAC Initiation
Cilostazol
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients for Each Type of Antiplatelet Treatment at the Time of Study Visit According to Duration Since the First NOAC Initiation
Triflusal
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number of Patients for Each Type of Antiplatelet Treatment at the Time of Study Visit According to Duration Since the First NOAC Initiation
Dipyridamole
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Patients for Each Type of Antiplatelet Treatment at the Time of Study Visit According to Duration Since the First NOAC Initiation
Others
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Time in treatment with antiplatelet agents (in years) according to duration since the first NOAC initiation is reported.
Outcome measures
| Measure |
Sex: Male
n=39 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=461 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Time in Treatment With Antiplatelet Agents (in Years) According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
|
5.82 Years
Standard Deviation 1.66
|
5.98 Years
Standard Deviation 7.06
|
—
|
—
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Clinical Frailty Scale (CFS) is used commonly to assess frailty. It is a 9-point scale from 1 to 9 (1=very fit; 2=well; 3=Managing well; 4=Vulnerable; 5=Mildly frail; 6=Moderately frail; 7=Severely frail; 8=very severely frail; 9=terminally ill) that summarizes the overall level of fitness or frailty of an older adult after they had been evaluated by a health care professional. Applying the CFS to patients is quick and requires data collection by watching the patient (mobilize), inquiring about their habitual physical activity and ability. A person with a score \>4 was considered frail.
Outcome measures
| Measure |
Sex: Male
n=192 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=76 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=166 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=66 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients in Each Score of Clinical Frailty Scale Grading at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
1-Very fit
|
11 Participants
|
6 Participants
|
8 Participants
|
0 Participants
|
|
Number of Patients in Each Score of Clinical Frailty Scale Grading at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
2-Well
|
24 Participants
|
15 Participants
|
18 Participants
|
9 Participants
|
|
Number of Patients in Each Score of Clinical Frailty Scale Grading at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
3-Managing well
|
79 Participants
|
23 Participants
|
44 Participants
|
24 Participants
|
|
Number of Patients in Each Score of Clinical Frailty Scale Grading at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
4-Vulnerable
|
45 Participants
|
11 Participants
|
46 Participants
|
19 Participants
|
|
Number of Patients in Each Score of Clinical Frailty Scale Grading at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
5-Mildly frail
|
13 Participants
|
8 Participants
|
16 Participants
|
7 Participants
|
|
Number of Patients in Each Score of Clinical Frailty Scale Grading at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
6-Moderately frail
|
15 Participants
|
10 Participants
|
24 Participants
|
3 Participants
|
|
Number of Patients in Each Score of Clinical Frailty Scale Grading at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
7-Severely frail
|
4 Participants
|
3 Participants
|
9 Participants
|
3 Participants
|
|
Number of Patients in Each Score of Clinical Frailty Scale Grading at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
8-Very severely frail
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients in Each Score of Clinical Frailty Scale Grading at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
9-Terminally ill
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Clinical Frailty Scale (CFS) is used commonly to assess frailty. It is a 9-point scale from 1 to 9 (1=very fit; 2=well; 3=Managing well; 4=Vulnerable; 5=Mildly frail; 6=Moderately frail; 7=Severely frail; 8=very severely frail; 9=terminally ill) that summarizes the overall level of fitness or frailty of an older adult after they had been evaluated by a health care professional. Applying the CFS to patients is quick and requires data collection by watching the patient (mobilize), inquiring about their habitual physical activity and ability. CFS was categorized in two categories, according to this ranges: * Frailty patients - CFS scoring \>4 * Non-frailty patients - CFS scoring ≤4
Outcome measures
| Measure |
Sex: Male
n=192 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=76 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=166 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=66 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients in Each Category Clinical Frailty Scale at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Non-frailty patients (CFS scoring ≤4)
|
159 Participants
|
55 Participants
|
116 Participants
|
52 Participants
|
|
Number of Patients in Each Category Clinical Frailty Scale at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Frailty patients (CFS scoring >4)
|
33 Participants
|
21 Participants
|
50 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: At the single study visit (Day 1).Population: Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Reason for First NOAC usage was categorized in the following two categories: * Primary prevention; * Secondary prevention.
Outcome measures
| Measure |
Sex: Male
n=190 Participants
This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Sex: Female
n=75 Participants
This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Age: ≥85 Years
n=166 Participants
This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
|
Edoxaban
n=66 Participants
Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
|
|---|---|---|---|---|
|
Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Usage at the Time of First NOAC Initiation According to Current NOAC Type
Primary prevention
|
138 Participants
|
61 Participants
|
135 Participants
|
54 Participants
|
|
Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Usage at the Time of First NOAC Initiation According to Current NOAC Type
Secondary prevention
|
52 Participants
|
14 Participants
|
31 Participants
|
12 Participants
|
Adverse Events
All Dabigatran Patients
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Dabigatran Patients
n=206 participants at risk
This group included all patients who received dabigatran either as first NOAC (patients who the first NOAC prescribed was dabigatran), or as second NOAC (patients who stopped the first prescribed NOAC and received dabigatran as second NOAC), or as third NOAC (patients who stopped the second prescribed NOAC and received dabigatran as third NOAC).
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.49%
1/206 • Information about the adverse events (AEs) was collected from the patients' medical records at the time of single study visit (Day 1). AEs collection covered a total time of 10 years.
Adverse events were collected and reported only for patients who received dabigatran either as first NOAC, or second NOAC or third NOAC.For rivaroxaban, apixaban and edoxaban patients' adverse events were not assessed.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.49%
1/206 • Information about the adverse events (AEs) was collected from the patients' medical records at the time of single study visit (Day 1). AEs collection covered a total time of 10 years.
Adverse events were collected and reported only for patients who received dabigatran either as first NOAC, or second NOAC or third NOAC.For rivaroxaban, apixaban and edoxaban patients' adverse events were not assessed.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.49%
1/206 • Information about the adverse events (AEs) was collected from the patients' medical records at the time of single study visit (Day 1). AEs collection covered a total time of 10 years.
Adverse events were collected and reported only for patients who received dabigatran either as first NOAC, or second NOAC or third NOAC.For rivaroxaban, apixaban and edoxaban patients' adverse events were not assessed.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.49%
1/206 • Information about the adverse events (AEs) was collected from the patients' medical records at the time of single study visit (Day 1). AEs collection covered a total time of 10 years.
Adverse events were collected and reported only for patients who received dabigatran either as first NOAC, or second NOAC or third NOAC.For rivaroxaban, apixaban and edoxaban patients' adverse events were not assessed.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER