Trial Outcomes & Findings for This Study Observes the Use of New Oral Anticoagulants (NOACs) in Patients With a Heart Rhythm Disorder in Spain (NCT NCT03285373)

Results Overview

Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics; age, at the time of the start of the first NOAC initiation.

Recruitment status

COMPLETED

Target enrollment

1008 participants

Primary outcome timeframe

Start of the first NOAC treatment

Results posted on

2020-02-18

Participant Flow

Patients with Non Valvular Atrial Fibrillation (NVAF) in Spain, mainly from the hospital setting were on treatment with New Oral Anticoagulant (NOAC) according to its approved local Summary of Product Characteristics (SmPC) and have initiated their first NOAC starting from November 2016 were included in this trial.

All patients were screened for eligibility to participate in the trial. Subjects attended specialist sites in Spain to ensure that subjects met all incl/excl criteria. 45 patients (out of 1008 enrolled), did not meet at least one of the selection criteria and were considered not eligible. Data analysis was carried out with 963 eligible patients.

Participant milestones

Participant milestones
Measure	Dabigatran Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Rivaroxaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Apixaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Edoxaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.
Overall Study STARTED	314	253	266	130
Overall Study COMPLETED	314	253	266	130
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=963 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Age, Continuous	73.6 Years STANDARD_DEVIATION 10.1 • n=963 Participants
Sex: Female, Male Female	406 Participants n=963 Participants
Sex: Female, Male Male	557 Participants n=963 Participants

PRIMARY outcome

Timeframe: Start of the first NOAC treatment

Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).

Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics; age, at the time of the start of the first NOAC initiation.

Outcome measures

Outcome measures
Measure	Dabigatran n=314 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Rivaroxaban n=253 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Apixaban n=266 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Edoxaban n=130 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	All Patients n=963 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation	72.8 Years Standard Deviation 9.9	72.5 Years Standard Deviation 10.7	72.6 Years Standard Deviation 9.8	74.0 Years Standard Deviation 10.0	72.8 Years Standard Deviation 10.1

PRIMARY outcome

Timeframe: Start of the first NOAC treatment

Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 21 patients CHA2DS2-VASc score was not available.

Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc Score) at the time of the start of the first NOAC initiation. The CHA2DS2-VASc score is a clinical prediction rule to estimate the risk of stroke in patients with Atrial Fibrillation (AF); it is frequently used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.

Outcome measures

Outcome measures
Measure	Dabigatran n=308 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Rivaroxaban n=251 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Apixaban n=254 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Edoxaban n=129 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	All Patients n=942 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation	3.2 Unit on Scale Standard Deviation 1.5	3.3 Unit on Scale Standard Deviation 1.6	3.3 Unit on Scale Standard Deviation 1.5	3.3 Unit on Scale Standard Deviation 1.5	3.3 Unit on Scale Standard Deviation 1.5

PRIMARY outcome

Timeframe: Start of the first NOAC treatment

Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 21 patients CHA2DS2-VASc score was not available.

Number of patients on risk (Low, Moderate and High) based on CHA2DS2-VASc Scores at the time of the start of the first NOAC initiation. The total CHA2DS2-VASc Scores score was stratified by category according to the following classification: 1. Low risk (score 0 in male; score 1 in female) 2. Moderate risk (score 1 in male; score 2 in female) 3. High risk (score ≥2 in male; score ≥3 in female)

Outcome measures

Outcome measures
Measure	Dabigatran n=308 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Rivaroxaban n=251 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Apixaban n=254 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Edoxaban n=129 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	All Patients n=942 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation Low risk	3 Participants	10 Participants	3 Participants	0 Participants	16 Participants
Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation Moderate risk	53 Participants	34 Participants	36 Participants	21 Participants	144 Participants
Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation High risk	252 Participants	207 Participants	215 Participants	108 Participants	782 Participants

PRIMARY outcome

Timeframe: Start of the first NOAC treatment

Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 23 patients the HAS-BLED score was not available.

Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol (HAS-BLED Score) at the time of the start of the first NOAC initiation. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. The high scores to a great risk of bleeding and a low score corresponds to a lower risk of bleeding.

Outcome measures

Outcome measures
Measure	Dabigatran n=308 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Rivaroxaban n=251 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Apixaban n=253 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Edoxaban n=128 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	All Patients n=940 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation	1.8 unit on scale Standard Deviation 1.0	1.8 unit on scale Standard Deviation 1.1	1.7 unit on scale Standard Deviation 1.1	1.8 unit on scale Standard Deviation 1.0	1.8 unit on scale Standard Deviation 1.1

PRIMARY outcome

Timeframe: Start of the first NOAC treatment

Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 23 patients the HAS-BLED score was not available.

Number of patients on risk (Low, Moderate and High) based on HAS-BLED Score at the time of the start of the first NOAC initiation. The total HAS-BLED Score was stratified by category according to the following classification: 1. Low risk (score 0) 2. Moderate risk (score 1-2) 3. High risk (score ≥3)

Outcome measures

Outcome measures
Measure	Dabigatran n=308 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Rivaroxaban n=251 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Apixaban n=253 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Edoxaban n=128 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	All Patients n=940 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation Low risk	17 Participants	29 Participants	27 Participants	11 Participants	84 Participants
Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation Moderate risk	219 Participants	157 Participants	170 Participants	86 Participants	632 Participants
Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation High risk	72 Participants	65 Participants	56 Participants	31 Participants	224 Participants

SECONDARY outcome

Timeframe: single visit (Day 1)

Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.

Appropriateness of NOACs prescription based on national recommendations. For this, it was reviewed if the presence of at least one of the following clinical reason or reason related to International Normalized Ratio (INR) control were met. Reason 1: Patients with known hypersensitivity or with specific contraindications to the use of acenocoumarol or warfarin; Reason 2: Patients with a history of intracranial hemorrhage (ICH) (except during the acute phase); Reason 3: Patients with ischemic stroke who present high-risk clinical and neuroimaging criteria for ICH; Reason 4: Patients on VKA treatment who suffer from severe arterial thromboembolic events despite good INR control; Reason 5: Patients who have started treatment with VKA in which it is not possible to maintain INR control within range (2-3) despite good therapeutic compliance; Reason 6: impossibility of access to conventional INR control; Reason 7: Other reason; Reason 8; Unknown.

Outcome measures

Outcome measures
Measure	Dabigatran n=963 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Rivaroxaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Apixaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Edoxaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	All Patients Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Appropriateness of NOACs Prescription Reason 2	10 Participants	—	—	—	—
Appropriateness of NOACs Prescription Reason 3	16 Participants	—	—	—	—
Appropriateness of NOACs Prescription Reason 4	16 Participants	—	—	—	—
Appropriateness of NOACs Prescription Reason 5	271 Participants	—	—	—	—
Appropriateness of NOACs Prescription Reason 6	102 Participants	—	—	—	—
Appropriateness of NOACs Prescription Reason 7	342 Participants	—	—	—	—
Appropriateness of NOACs Prescription Reason 8	118 Participants	—	—	—	—
Appropriateness of NOACs Prescription Reason 1	88 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 1 year (data collected during single visit on day 1)

Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.

Mean number of visits to the physician per year considered for the NOAC Management.

Outcome measures

Outcome measures
Measure	Dabigatran n=963 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Rivaroxaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Apixaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Edoxaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	All Patients Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Mean Number of Visits to the Physician Per Year	2.0 visits per year Standard Deviation 1.1	—	—	—	—

SECONDARY outcome

Timeframe: Through the observational period with an average of 9.4 (first NOAC), 9.6 (All NOAC) and 5.1 (Subsequent NOAC) months, data collected during a single visit.

Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.

Duration of NOAC treatment (First NOAC, All NOAC and Subsequent NOAC).

Outcome measures

Outcome measures
Measure	Dabigatran n=963 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Rivaroxaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Apixaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Edoxaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	All Patients Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Duration of First NOAC, All NOAC and Subsequent NOAC Treatment First NOAC	9.4 Months Standard Deviation 6.5	—	—	—	—
Duration of First NOAC, All NOAC and Subsequent NOAC Treatment All NOAC	9.6 Months Standard Deviation 6.5	—	—	—	—
Duration of First NOAC, All NOAC and Subsequent NOAC Treatment Subsequent NOAC	5.1 Months Standard Deviation 4.1	—	—	—	—

SECONDARY outcome

Timeframe: single visit (Day 1)

Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.

Number of patients who required discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC

Outcome measures

Outcome measures
Measure	Dabigatran n=963 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Rivaroxaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Apixaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Edoxaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	All Patients Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC Discontinue treatment	4 Participants	—	—	—	—
Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC Dose adjustment	20 Participants	—	—	—	—
Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC Change to a new NOAC	32 Participants	—	—	—	—
Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC No change	907 Participants	—	—	—	—

SECONDARY outcome

Timeframe: single visit (Day 1)

Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria) who changed to a new NOAC. As per protocol this endpoint was to be analysed overall for all eligible patients who changed to a new NOAC. Thus, this endpoint was not analysed by NOAC type.

Number of patients who changed from one NOAC to a new NOAC type and dose. The treatment and its dose displayed below refer to the subsequent NOAC.

Outcome measures

Outcome measures
Measure	Dabigatran n=32 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Rivaroxaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Apixaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Edoxaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	All Patients Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose Dabigatran 110 mg	5 Participants	—	—	—	—
Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose Dabigatran 150 mg	4 Participants	—	—	—	—
Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose Rivaroxaban 10 mg	1 Participants	—	—	—	—
Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose Rivaroxaban 15 mg	2 Participants	—	—	—	—
Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose Rivaroxaban 20 mg	4 Participants	—	—	—	—
Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose Apixaban 2.5 mg	2 Participants	—	—	—	—
Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose Apixaban 5 mg	8 Participants	—	—	—	—
Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose Edoxaban 30 mg	2 Participants	—	—	—	—
Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose Edoxaban 60 mg	4 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Start of the first NOAC treatment

Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria) who required treatment changes.As per protocol this endpoint was to be analysed overall for all eligible patients who required treatment changes. Thus, this endpoint was not analysed by NOAC type.

Reason for treatment changes such as discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC.

Outcome measures

Outcome measures
Measure	Dabigatran n=56 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Rivaroxaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Apixaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Edoxaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	All Patients Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Reason for Treatment Changes Lack of efficacy	5 Participants	—	—	—	—
Reason for Treatment Changes Investigator decision	30 Participants	—	—	—	—
Reason for Treatment Changes Patient decision	7 Participants	—	—	—	—
Reason for Treatment Changes Adverse event	14 Participants	—	—	—	—

SECONDARY outcome

Timeframe: single visit (Day 1)

Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).

Number of patient with Previous Treatment with Vitamin K Antagonists.

Outcome measures

Outcome measures
Measure	Dabigatran n=314 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Rivaroxaban n=253 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Apixaban n=266 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Edoxaban n=130 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	All Patients n=963 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Number of Patients With Previous Treatment With Vitamin K Antagonists Yes	146 Participants	125 Participants	100 Participants	53 Participants	424 Participants
Number of Patients With Previous Treatment With Vitamin K Antagonists No	168 Participants	128 Participants	166 Participants	77 Participants	539 Participants

SECONDARY outcome

Timeframe: Through the observational period with an average of 43.8 months, data collected during a single visit.

Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). As per protocol this endpoint was to be analysed only for patients with previous VKA treatment (n=424). Dates of start and/or stop of previous VKA treatment were not available for 62 patients.

Duration of previous VKA treatment is the time from start of the VKA treatment until stopped to start with the first NOAC

Outcome measures

Outcome measures
Measure	Dabigatran n=124 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Rivaroxaban n=107 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Apixaban n=81 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Edoxaban n=50 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	All Patients n=362 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Duration of Previous VKA Treatment	46.6 Months Standard Deviation 52.5	37.0 Months Standard Deviation 50.6	54.5 Months Standard Deviation 58.9	34.0 Months Standard Deviation 47.9	43.8 Months Standard Deviation 53.2

SECONDARY outcome

Timeframe: single visit (Day 1)

Population: The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.

At the time of the inclusion, the physician performed a following small questionnaire to the patients, to answer yes/no, in order to assess the patient's knowledge about his illness and the anticoagulant treatment prescribed. Question 1. Do you know why you are being treated with an anticoagulant? Question 2. Do you know which the effect of the anticoagulant treatment is? Question 3. Do you know what could happen if you don't take the anticoagulant treatment? Question 4. Do you mind taking the anticoagulant treatment?

Outcome measures

Outcome measures
Measure	Dabigatran n=963 Participants Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Rivaroxaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Apixaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Edoxaban Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	All Patients Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Patient's Knowledge About His Condition Question 1. · Yes	845 Participants	—	—	—	—
Patient's Knowledge About His Condition Question 1. · No	118 Participants	—	—	—	—
Patient's Knowledge About His Condition Question 2. · Yes	820 Participants	—	—	—	—
Patient's Knowledge About His Condition Question 2. · No	143 Participants	—	—	—	—
Patient's Knowledge About His Condition Question 3. · Yes	766 Participants	—	—	—	—
Patient's Knowledge About His Condition Question 3. · No	197 Participants	—	—	—	—
Patient's Knowledge About His Condition Question 4. · Yes	333 Participants	—	—	—	—
Patient's Knowledge About His Condition Question 4. · No	630 Participants	—	—	—	—

Adverse Events

Dabigatran

Serious events: 3 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Dabigatran n=314 participants at risk Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.
General disorders Sudden death	0.32% 1/314 • From Informed consent signed until the end of the trial, up to 12 months. The study design was of non-interventional nature and the study was conducted within the conditions of the approved marketing authorization. Sufficient data were available to support the evidence on the safety and efficacy of the studied BI drug. For this reason Adverse Drug Reactions (ADR) and fatal Adverse Events (AE) were only collected for one of the NOACs (dabigatran). No data was collected for the other NOACs (Rivaroxaban, Apixaban and Edoxaban) reported on in this study.
Nervous system disorders Ischaemic stroke	0.32% 1/314 • From Informed consent signed until the end of the trial, up to 12 months. The study design was of non-interventional nature and the study was conducted within the conditions of the approved marketing authorization. Sufficient data were available to support the evidence on the safety and efficacy of the studied BI drug. For this reason Adverse Drug Reactions (ADR) and fatal Adverse Events (AE) were only collected for one of the NOACs (dabigatran). No data was collected for the other NOACs (Rivaroxaban, Apixaban and Edoxaban) reported on in this study.
Nervous system disorders Cerebrovascular disorder	0.32% 1/314 • From Informed consent signed until the end of the trial, up to 12 months. The study design was of non-interventional nature and the study was conducted within the conditions of the approved marketing authorization. Sufficient data were available to support the evidence on the safety and efficacy of the studied BI drug. For this reason Adverse Drug Reactions (ADR) and fatal Adverse Events (AE) were only collected for one of the NOACs (dabigatran). No data was collected for the other NOACs (Rivaroxaban, Apixaban and Edoxaban) reported on in this study.

Other adverse events

Adverse event data not reported

Additional Information

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Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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