Trial Outcomes & Findings for Patient Characteristics, Treatment Patterns And Incidence Of Events (Discontinuation, Persistence, Key Primary Clinical Outcomes) In NVAF Patients Initiating OAC Therapy In Colombia (NCT NCT04234698)
NCT ID: NCT04234698
Last Updated: 2025-02-06
Results Overview
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
COMPLETED
2076 participants
At index date (anytime between 01-January-2013 to 30-June-2018)
2025-02-06
Participant Flow
Data of participants diagnosed with non-valvular atrial fibrillation (NVAF) who initiated treatment with warfarin and any of new oral anticoagulants (NOACs) \[dabigatran, rivaroxaban, apixaban\] between 01-January-2013 to 30-June-2018,registered in Health Maintenance Organizations(HMO)of Colombia were observed retrospectively. Data was retrieved from claim database and medical records during approximately 2 months of this study.
Baseline for this study was 6 months prior to the index date. The index date was the date of first prescription with any of the oral anticoagulants (OACs).
Participant milestones
| Measure |
Warfarin
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs
Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|
|
Overall Study
STARTED
|
459
|
1617
|
|
Overall Study
COMPLETED
|
459
|
1617
|
|
Overall Study
NOT COMPLETED
|
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 |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs
n=1617 Participants
Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
Total
n=2076 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.6 Years
STANDARD_DEVIATION 10.0 • n=459 Participants
|
73.7 Years
STANDARD_DEVIATION 10.0 • n=1617 Participants
|
73.3 Years
STANDARD_DEVIATION 10.5 • n=2076 Participants
|
|
Sex: Female, Male
Female
|
258 Participants
n=459 Participants
|
926 Participants
n=1617 Participants
|
1184 Participants
n=2076 Participants
|
|
Sex: Female, Male
Male
|
201 Participants
n=459 Participants
|
691 Participants
n=1617 Participants
|
892 Participants
n=2076 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Height
|
160.4 Centimeters
STANDARD_DEVIATION 10.2 • n=459 Participants
|
160.9 Centimeters
STANDARD_DEVIATION 9.9 • n=1617 Participants
|
160.8 Centimeters
STANDARD_DEVIATION 10.0 • n=2076 Participants
|
|
Weight
|
70.0 Kilograms
STANDARD_DEVIATION 14.0 • n=459 Participants
|
70.7 Kilograms
STANDARD_DEVIATION 14.4 • n=1617 Participants
|
70.0 Kilograms
STANDARD_DEVIATION 14.0 • n=2076 Participants
|
|
Number of Participants According to Geographic Regions
Bogota/center
|
175 Participants
n=459 Participants
|
497 Participants
n=1617 Participants
|
672 Participants
n=2076 Participants
|
|
Number of Participants According to Geographic Regions
Atlantic Coast
|
35 Participants
n=459 Participants
|
486 Participants
n=1617 Participants
|
521 Participants
n=2076 Participants
|
|
Number of Participants According to Geographic Regions
Coffee belt
|
122 Participants
n=459 Participants
|
202 Participants
n=1617 Participants
|
324 Participants
n=2076 Participants
|
|
Number of Participants According to Geographic Regions
Santander
|
48 Participants
n=459 Participants
|
146 Participants
n=1617 Participants
|
194 Participants
n=2076 Participants
|
|
Number of Participants According to Geographic Regions
Antioquia
|
60 Participants
n=459 Participants
|
128 Participants
n=1617 Participants
|
188 Participants
n=2076 Participants
|
|
Number of Participants According to Geographic Regions
Center-West
|
16 Participants
n=459 Participants
|
133 Participants
n=1617 Participants
|
149 Participants
n=2076 Participants
|
|
Number of Participants According to Geographic Regions
Eastern plains
|
3 Participants
n=459 Participants
|
25 Participants
n=1617 Participants
|
28 Participants
n=2076 Participants
|
|
Body Mass Index (BMI)
|
27.1 Kilograms per meter square
STANDARD_DEVIATION 4.9 • n=459 Participants
|
27.3 Kilograms per meter square
STANDARD_DEVIATION 5.0 • n=1617 Participants
|
27.3 Kilograms per meter square
STANDARD_DEVIATION 4.9 • n=2076 Participants
|
|
Number of Participants With Alcohol Intake at OAC Prescription Date
|
5 Participants
n=459 Participants
|
10 Participants
n=1617 Participants
|
15 Participants
n=2076 Participants
|
|
Number of Participants With History of Comorbidities at Index Date
Ischemic or Hemorrhagic Stroke
|
56 Participants
n=459 Participants
|
263 Participants
n=1617 Participants
|
319 Participants
n=2076 Participants
|
|
Number of Participants With History of Comorbidities at Index Date
Gastrointestinal Bleeding
|
5 Participants
n=459 Participants
|
20 Participants
n=1617 Participants
|
25 Participants
n=2076 Participants
|
|
Number of Participants With History of Comorbidities at Index Date
Intracranial Bleeding
|
0 Participants
n=459 Participants
|
6 Participants
n=1617 Participants
|
6 Participants
n=2076 Participants
|
|
Number of Participants With History of Comorbidities at Index Date
Transient Ischemic Attack
|
4 Participants
n=459 Participants
|
27 Participants
n=1617 Participants
|
31 Participants
n=2076 Participants
|
|
Number of Participants With History of Comorbidities at Index Date
Thromboembolism
|
0 Participants
n=459 Participants
|
0 Participants
n=1617 Participants
|
0 Participants
n=2076 Participants
|
|
Number of Participants With History of Comorbidities at Index Date
Other bleeding
|
1 Participants
n=459 Participants
|
12 Participants
n=1617 Participants
|
13 Participants
n=2076 Participants
|
|
Number of Participants With Bleeding History or Predisposition to Bleeding at Start of OAC Treatment
|
1 Participants
n=459 Participants
|
12 Participants
n=1617 Participants
|
13 Participants
n=2076 Participants
|
|
Number of Participants With International Normalized Ratio(INR)Greater Than(>)60%: Start OAC Therapy
|
134 Participants
n=459 Participants • INR was evaluated only for participants who were exposed to warfarin.
|
0 Participants
INR was evaluated only for participants who were exposed to warfarin.
|
134 Participants
n=459 Participants • INR was evaluated only for participants who were exposed to warfarin.
|
PRIMARY outcome
Timeframe: At index date (anytime between 01-January-2013 to 30-June-2018)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=950 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
n=405 Participants
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
n=262 Participants
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Time to Diagnose NVAF by Each OAC Treatment
|
71 Days
Standard Deviation 230.8
|
324 Days
Standard Deviation 712.2
|
218 Days
Standard Deviation 541.2
|
406 Days
Standard Deviation 676.0
|
PRIMARY outcome
Timeframe: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
Participants classified according to the comorbidities they had were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. One participant may have more than one comorbidity.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=1617 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Participants With Comorbidities
Diabetes Mellitus
|
100 Participants
|
370 Participants
|
—
|
—
|
|
Number of Participants With Comorbidities
Liver Disease
|
5 Participants
|
25 Participants
|
—
|
—
|
|
Number of Participants With Comorbidities
Hypertension
|
386 Participants
|
1430 Participants
|
—
|
—
|
|
Number of Participants With Comorbidities
Rheumatic disease
|
23 Participants
|
58 Participants
|
—
|
—
|
|
Number of Participants With Comorbidities
Acquired Immune Deficiency Syndrome (AIDS)
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Comorbidities
Chronic Kidney Disease
|
196 Participants
|
892 Participants
|
—
|
—
|
|
Number of Participants With Comorbidities
Moderate Renal Disease
|
163 Participants
|
661 Participants
|
—
|
—
|
|
Number of Participants With Comorbidities
Congestive Heart Failure
|
86 Participants
|
231 Participants
|
—
|
—
|
|
Number of Participants With Comorbidities
Acute Myocardial Infarction
|
70 Participants
|
308 Participants
|
—
|
—
|
|
Number of Participants With Comorbidities
Chronic Obstructive Pulmonary Disease (COPD)
|
84 Participants
|
276 Participants
|
—
|
—
|
|
Number of Participants With Comorbidities
Peripheral Vascular Disease
|
30 Participants
|
73 Participants
|
—
|
—
|
|
Number of Participants With Comorbidities
Dementia
|
11 Participants
|
48 Participants
|
—
|
—
|
|
Number of Participants With Comorbidities
Hemiplegia
|
9 Participants
|
38 Participants
|
—
|
—
|
|
Number of Participants With Comorbidities
Connective Tissue Disease
|
23 Participants
|
58 Participants
|
—
|
—
|
|
Number of Participants With Comorbidities
Leukemia and Lymphoma
|
2 Participants
|
9 Participants
|
—
|
—
|
|
Number of Participants With Comorbidities
Peptic Ulcer Disease
|
4 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants With Comorbidities
Metastatic Solid Tumor (Cancer)
|
0 Participants
|
21 Participants
|
—
|
—
|
|
Number of Participants With Comorbidities
Acute myocardial infarction
|
70 Participants
|
308 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At index date (any time between 01-January-2013 to 30-June-2018)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=1617 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Participants With Uncontrolled Hypertension at OAC Prescription Date
|
19 Participants
|
50 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At index date (anytime between 01-January-2013 to 30-June-2018)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=1617 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Participants With Use of Aspirin at Start OAC Treatment
|
191 Participants
|
660 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At index date (anytime between 01-January-2013 to 30-June-2018)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=1617 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Participants With Use of Clopidogrel at Start of OAC Treatment
|
37 Participants
|
133 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At index date (anytime between 01-January-2013 to 30-June-2018)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018. In this study Aspirin was not considered as NSAID due to doses used in Colombia.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=1617 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Participants With Use of Non-Steroidal Anti-Inflammatory Drugs at Start of OAC Treatment
|
18 Participants
|
50 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At index date (anytime between 01-January-2013 to 30-June-2018)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
The risk of bleeding in participants was assessed using Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile INR, Elderly, (age \>65 years), Drugs or alcohol (HAS-BLED) score. Score ranged from 0 to 8 with higher scores indicating greater risk of bleeding. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=1617 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
HAS-BLED Score at Start of OAC Treatment
|
2.25 Units on a scale
Standard Deviation 0.95
|
1.99 Units on a scale
Standard Deviation 0.90
|
—
|
—
|
PRIMARY outcome
Timeframe: At index date (anytime between 01-January-2013 to 30-June-2018)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
The CHA2DS2-VASc scale is an evaluation of stroke risk in participants with atrial fibrillation. CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score , with total scores ranging from 0 to 9, with low scores indicating low risk for stroke, and high scores indicating high risk for stroke. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=1617 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
CHA2DS2-VASc Score at Start of OAC Treatment
|
3.6 Units on a scale
Standard Deviation 1.5
|
3.6 Units on a scale
Standard Deviation 1.5
|
—
|
—
|
PRIMARY outcome
Timeframe: At index date (anytime between 01-January-2013 to 30-June-2018)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=1617 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Participants With Anemia at Start of OAC Treatment
|
62 Participants
|
217 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=1617 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Participants With Stroke
|
56 Participants
|
263 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=56 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=263 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Duration of Follow-up in Participants With Stroke
|
244 Days
Standard Deviation 157
|
680 Days
Standard Deviation 559
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
Number of participants with type of stroke classified as either ischemic cerebrovascular event or hemorrhagic cerebrovascular event were reported in this outcome measure. Participants who reported cerebral infarction, stroke: not specified as hemorrhage or infarction in their medical history during the follow-up period were classified under ischemic cerebrovascular event and participants who reported subarachnoid hemorrhage, intracerebral hemorrhage and other nontraumatic intracranial hemorrhage in their medical record were classified under hemorrhagic stroke. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=56 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=263 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Participants According to Type of Stroke
Ischemic cerebrovascular event
|
11 Participants
|
45 Participants
|
—
|
—
|
|
Number of Participants According to Type of Stroke
Hemorrhagic cerebrovascular event
|
5 Participants
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
The number of participants who had pulmonary embolism were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=1617 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Participants With Pulmonary Embolism
|
1 Participants
|
5 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=1 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=5 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Duration of Follow-up in Participants With Pulmonary Embolism
|
25 Days
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
620 Days
Standard Deviation 409
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
The number of participants who had gastrointestinal bleeding were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=1617 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Participants With Gastrointestinal Bleeding
|
19 Participants
|
23 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=19 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=23 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Duration of Follow-up in Participants With Gastrointestinal Bleeding
|
501 Days
Standard Deviation 561
|
444 Days
Standard Deviation 298
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
The number of participants who had intracranial bleeding were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=1617 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Participants With Intracranial Bleeding
|
5 Participants
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=5 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=2 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Duration of Follow-up in Participants With Intracranial Bleeding
|
400 Days
Standard Deviation 355
|
206 Days
Standard Deviation 228
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date until death or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=1617 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Deaths
|
1 Participants
|
5 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date until death or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=1 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=5 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Duration of Follow-up in Participants Who Died
|
881 Days
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was analyzed.
|
722 Days
Standard Deviation 742
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date until switch of treatment, discontinuation, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
Persistence was defined as the time under each OAC treatment, calculated as the time in days from the index date to the date of discontinuation or change of treatment. Participants were censored at the end of their follow-up period. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=950 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
n=405 Participants
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
n=262 Participants
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Time Under OAC Treatment (Persistence) by Each OAC Treatment
|
440 Days
Interval 158.0 to 805.0
|
491 Days
Interval 181.0 to 985.0
|
364 Days
Interval 202.0 to 627.0
|
608 Days
Interval 279.0 to 1176.0
|
PRIMARY outcome
Timeframe: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
The number of participants who had other major bleeding were reported in this outcome measure. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=1617 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Participants With Other Major Bleeding
|
17 Participants
|
19 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=17 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=19 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Duration of Follow-up in Participants With Other Major Bleeding
|
233 Days
Standard Deviation 385
|
585 Days
Standard Deviation 631
|
—
|
—
|
PRIMARY outcome
Timeframe: At index date (anytime between 01-January-2013 to 30-June-2018)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=950 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
n=405 Participants
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
n=262 Participants
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Dose of Initial OAC Prescription by Each OAC Treatment
|
4.5 Milligrams
Standard Deviation 2.6
|
17.9 Milligrams
Standard Deviation 2.7
|
7.8 Milligrams
Standard Deviation 2.5
|
239 Milligrams
Standard Deviation 48.5
|
PRIMARY outcome
Timeframe: At index date (anytime between 01-January-2013 to 30-June-2018)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=950 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
n=405 Participants
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
n=262 Participants
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Doses Dispensed at Initial OAC Treatment by Each OAC Treatment
|
5 Doses
Interval 2.5 to 5.0
|
20 Doses
Interval 15.0 to 20.0
|
10 Doses
Interval 5.0 to 10.0
|
220 Doses
Interval 220.0 to 300.0
|
PRIMARY outcome
Timeframe: From baseline (index date) until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
Baseline was defined as the time of index date which was defined as the first prescription with any of the oral anticoagulants, that is, participants with NVAF for the first time starting a therapy with any of the NOACs between 01-Jan-2013 and 30-Jun-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=950 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
n=405 Participants
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
n=262 Participants
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Participants With Dose Reduction by Each OAC Treatment
|
0 Participants
|
375 Participants
|
173 Participants
|
159 Participants
|
PRIMARY outcome
Timeframe: From index date until date of dose reduction or until end of follow-up, anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=106 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=32 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
n=10 Participants
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
n=10 Participants
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Time to Dose Reduction by Each OAC Treatment
|
68.5 Days
Interval 26.8 to 202.8
|
479 Days
Interval 144.8 to 725.2
|
523 Days
Interval 308.8 to 789.8
|
324 Days
Interval 103.5 to 1002.2
|
PRIMARY outcome
Timeframe: From index date until date of discontinuation, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
Discontinuation was defined as the first day of a period of at least 30 consecutive days in which 0 days' supply for the index OAC was detected. The date of discontinuation was the end date of the last filled prescription before the treatment gap. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=1617 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Discontinuation
|
78 Participants
|
147 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date until date of discontinuation, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
Time to discontinuation was defined as the number of days from the date of index oral anticoagulant prescription to the date of discontinuation. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=78 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=147 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Time to Discontinuation
|
332 Days
Interval 130.0 to 679.0
|
463 Days
Interval 222.0 to 856.0
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
Discontinuation was defined as the first day of a period of at least 30 consecutive days in which 0 days' supply for the index OAC was detected. The date of discontinuation was the end date of the last filled prescription before the treatment gap. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=78 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=147 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Participants According to Reasons for Discontinuation
Adverse drug reaction - not bleeding
|
4 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants According to Reasons for Discontinuation
Adverse drug reaction - any bleeding
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants According to Reasons for Discontinuation
Bleeding risk
|
5 Participants
|
12 Participants
|
—
|
—
|
|
Number of Participants According to Reasons for Discontinuation
Change to rhythm control
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants According to Reasons for Discontinuation
INR out of goal
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants According to Reasons for Discontinuation
No identifiable cause
|
32 Participants
|
73 Participants
|
—
|
—
|
|
Number of Participants According to Reasons for Discontinuation
NVAF improvement
|
13 Participants
|
17 Participants
|
—
|
—
|
|
Number of Participants According to Reasons for Discontinuation
Another event (acute myocardial infarction, worsening of renal failure, worsening of NVAF)
|
7 Participants
|
11 Participants
|
—
|
—
|
|
Number of Participants According to Reasons for Discontinuation
Participant preference
|
10 Participants
|
20 Participants
|
—
|
—
|
|
Number of Participants According to Reasons for Discontinuation
Problems related with drug access
|
2 Participants
|
5 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From 1 Month to maximum 6.5 years (Jan 2013 to Jul 2019)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. This outcome measure was planned to be analyzed for the warfarin group only.
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only)
0
|
54 Participants
|
—
|
—
|
—
|
|
Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only)
1
|
56 Participants
|
—
|
—
|
—
|
|
Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only)
2
|
53 Participants
|
—
|
—
|
—
|
|
Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only)
3
|
44 Participants
|
—
|
—
|
—
|
|
Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only)
4
|
34 Participants
|
—
|
—
|
—
|
|
Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only)
5
|
21 Participants
|
—
|
—
|
—
|
|
Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only)
6
|
28 Participants
|
—
|
—
|
—
|
|
Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only)
7
|
18 Participants
|
—
|
—
|
—
|
|
Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only)
8
|
16 Participants
|
—
|
—
|
—
|
|
Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only)
9
|
21 Participants
|
—
|
—
|
—
|
|
Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only)
10
|
13 Participants
|
—
|
—
|
—
|
|
Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only)
11
|
12 Participants
|
—
|
—
|
—
|
|
Number of Participants According to INR Measurements During Follow-up (Warfarin Group Only)
12 or more
|
89 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date until switch of treatment or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
A switch among anticoagulants was defined as a prescription filled for non-index anticoagulants within +/- 30 days after the date of discontinuation. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=1617 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Participants Who Switched to Another OAC Treatment
|
194 Participants
|
151 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date until switch of treatment or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
A switch among anticoagulants was defined as a prescription filled for non-index anticoagulants within +/- 30 days after the date of discontinuation. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=194 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=151 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Time to Switch to Another OAC Treatment
|
2309.0 Days
Interval 2274.7 to 2343.3
|
1114.0 Days
Interval 948.1 to 1279.9
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date until switch of treatment, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. Here ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure.
A switch among anticoagulants was defined as a prescription filled for non-index anticoagulants within +/- 30 days after the date of discontinuation. Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=194 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=151 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Participants According to Reasons for Switching OAC Treatment
Adverse drug reaction - not bleeding
|
2 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants According to Reasons for Switching OAC Treatment
Adverse drug reaction - any bleeding
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants According to Reasons for Switching OAC Treatment
Bleeding risk
|
7 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants According to Reasons for Switching OAC Treatment
Drug interaction
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants According to Reasons for Switching OAC Treatment
INR out of goal
|
65 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants According to Reasons for Switching OAC Treatment
No identifiable cause
|
112 Participants
|
87 Participants
|
—
|
—
|
|
Number of Participants According to Reasons for Switching OAC Treatment
Another event (acute myocardial infarction, worsening of renal failure, worsening of NVAF)
|
6 Participants
|
28 Participants
|
—
|
—
|
|
Number of Participants According to Reasons for Switching OAC Treatment
Participant preference
|
1 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants According to Reasons for Switching OAC Treatment
Problems related with drug access
|
0 Participants
|
7 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years)Population: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period.
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=459 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
n=950 Participants
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
n=405 Participants
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
n=262 Participants
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Participants With Concomitant Therapies by OAC Prescription
Beta (β)-blockers
|
305 Participants
|
641 Participants
|
270 Participants
|
186 Participants
|
|
Number of Participants With Concomitant Therapies by OAC Prescription
Statins
|
266 Participants
|
598 Participants
|
266 Participants
|
164 Participants
|
|
Number of Participants With Concomitant Therapies by OAC Prescription
Angiotensin II receptor blockers
|
232 Participants
|
543 Participants
|
247 Participants
|
164 Participants
|
|
Number of Participants With Concomitant Therapies by OAC Prescription
Furosemide
|
126 Participants
|
275 Participants
|
98 Participants
|
61 Participants
|
|
Number of Participants With Concomitant Therapies by OAC Prescription
Angiotensin converting enzyme inhibitor
|
119 Participants
|
182 Participants
|
71 Participants
|
50 Participants
|
|
Number of Participants With Concomitant Therapies by OAC Prescription
Proton pump inhibitor
|
116 Participants
|
242 Participants
|
105 Participants
|
63 Participants
|
|
Number of Participants With Concomitant Therapies by OAC Prescription
Calcium channel blockers
|
112 Participants
|
260 Participants
|
129 Participants
|
89 Participants
|
|
Number of Participants With Concomitant Therapies by OAC Prescription
Levothyroxine
|
96 Participants
|
224 Participants
|
81 Participants
|
52 Participants
|
|
Number of Participants With Concomitant Therapies by OAC Prescription
Thiazide diuretics
|
85 Participants
|
159 Participants
|
82 Participants
|
59 Participants
|
|
Number of Participants With Concomitant Therapies by OAC Prescription
Bronchodilators
|
76 Participants
|
144 Participants
|
45 Participants
|
33 Participants
|
|
Number of Participants With Concomitant Therapies by OAC Prescription
Potassium sparing diuretic
|
75 Participants
|
155 Participants
|
55 Participants
|
24 Participants
|
|
Number of Participants With Concomitant Therapies by OAC Prescription
Antiarrhythmics
|
75 Participants
|
206 Participants
|
65 Participants
|
55 Participants
|
|
Number of Participants With Concomitant Therapies by OAC Prescription
Oral antidiabetics
|
72 Participants
|
159 Participants
|
72 Participants
|
42 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months prior to index datePopulation: Analysis population included all eligible participants diagnosed with NVAF who initiated treatment with warfarin and NOACs between 01-January-2013 to 30-June-2018 or who were exposed to warfarin before 2013 and initiated treatment with NOACs within the established period. This outcome measure was planned to be analyzed for the NOACs group only.
Index date was defined as the first prescription with OAC (i.e., warfarin or NOAC) for NVAF between 01-January-2013 to 30-June-2018.
Outcome measures
| Measure |
Warfarin
n=1617 Participants
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs - Rivaroxaban
Participants diagnosed with NVAF, who initiated treatment with rivaroxaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated rivaroxaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Apixaban
Participants diagnosed with NVAF, who initiated treatment with apixaban between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated apixaban between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
NOACs - Dabigatran
Participants diagnosed with NVAF, who initiated treatment with dabigatran between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated dabigatran between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|---|---|
|
Number of Participants Who Were Previously Exposed to Warfarin (NOACs Group Only)
|
181 Participants
|
—
|
—
|
—
|
Adverse Events
Warfarin
NOACs
Serious adverse events
| Measure |
Warfarin
n=459 participants at risk
Participants diagnosed with NVAF who initiated treatment with warfarin between 01-January-2013 to 30-June-2018 were observed in this retrospective study. Participants were followed up until July 2019.
|
NOACs
n=1617 participants at risk
Participants diagnosed with NVAF, who initiated treatment with any of the NOACs (dabigatran, rivaroxaban and apixaban) between 01-January-2013 and 30-June-2018 were observed in this retrospective study. Participants who were exposed to warfarin before 2013 and initiated NOACs between 01-January-2013 and 30-June-2018 were also included. Participants were followed up until July 2019.
|
|---|---|---|
|
Blood and lymphatic system disorders
Gastrointestinal bleeding
|
4.1%
19/459 • From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years); retrieved data was analyzed during approximately 2 months of this observational study
The study was a retrospective study of existing medical records and claim database; hence, only adverse events related to major bleeding were collected and reported. There was no specific medical dictionary utilized to record adverse events. Non-SAEs were not collected and reported.
|
1.4%
23/1617 • From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years); retrieved data was analyzed during approximately 2 months of this observational study
The study was a retrospective study of existing medical records and claim database; hence, only adverse events related to major bleeding were collected and reported. There was no specific medical dictionary utilized to record adverse events. Non-SAEs were not collected and reported.
|
|
Blood and lymphatic system disorders
Other major bleeding
|
3.7%
17/459 • From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years); retrieved data was analyzed during approximately 2 months of this observational study
The study was a retrospective study of existing medical records and claim database; hence, only adverse events related to major bleeding were collected and reported. There was no specific medical dictionary utilized to record adverse events. Non-SAEs were not collected and reported.
|
1.2%
19/1617 • From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years); retrieved data was analyzed during approximately 2 months of this observational study
The study was a retrospective study of existing medical records and claim database; hence, only adverse events related to major bleeding were collected and reported. There was no specific medical dictionary utilized to record adverse events. Non-SAEs were not collected and reported.
|
|
Blood and lymphatic system disorders
Hemorrhagic cerebrovascular event
|
1.1%
5/459 • From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years); retrieved data was analyzed during approximately 2 months of this observational study
The study was a retrospective study of existing medical records and claim database; hence, only adverse events related to major bleeding were collected and reported. There was no specific medical dictionary utilized to record adverse events. Non-SAEs were not collected and reported.
|
0.12%
2/1617 • From index date until switch of treatment, discontinuation, death, first stroke/systemic embolism, or major bleeding, or until end of follow-up, whichever occurred first anytime between Jan 2013 to Jul 2019(approximately 6.5 years); retrieved data was analyzed during approximately 2 months of this observational study
The study was a retrospective study of existing medical records and claim database; hence, only adverse events related to major bleeding were collected and reported. There was no specific medical dictionary utilized to record adverse events. Non-SAEs were not collected and reported.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER