Trial Outcomes & Findings for A Study to Learn About the Effects of Medicines That Help in Thinning the Blood in People With Atrial Fibrillation (AF) Between 2016 and 2020 in France (NCT NCT05838664)

Results Overview

Incidence rate was defined as the number of events occurring during the follow-up period divided by the number of person-years of follow-up (sum of durations of follow-up period for incident participants). Incidence rate of stroke (ischemic or hemorrhage) in non-valvular AF participants who were exposed to OAC or unexposed to OAC were reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Recruitment status

COMPLETED

Target enrollment

2140403 participants

Primary outcome timeframe

Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Results posted on

2025-12-24

Participant Flow

Retrospective data on eligible atrial fibrillation (AF) participants were collected from French National Health Data System (Systeme National des Donnees de Sante) (01-Jan-2016 and 31-Dec-2019; maximum up to 48 months), with a 2-year historical period before index date; study conducted in France. Available data was evaluated as per study objectives, from 07-Jul-2023 to 30-Sep-2024 (approximately 14 months) in this retrospective observational study.

Participant milestones

Participant milestones
Measure	Participants Exposed to OACs Participants with AF who were exposed to vitamin K antagonist (VKA) or direct oral anticoagulant (\[DOACs\] including apixaban, rivaroxaban or dabigatran) and were identified from Systeme National des Donnees de Sante (SNDS) databases between 01-Jan-2016 and 31-Dec-2019, with a 2-year historical period before index date were included.	Participants Unexposed to OACs Participants with AF who were unexposed to VKA or DOACs including apixaban, rivaroxaban or dabigatran) and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019, with a 2-year historical period before index date were included.
Overall Study STARTED	1583444	556959
Overall Study COMPLETED	1583444	556959
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

Baseline characteristics by cohort
Measure	Participants Exposed to OACs n=943648 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Unexposed to OACs n=446645 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Total n=1390293 Participants Total of all reporting groups
Age, Customized <80 years	528010 Participants n=943648 Participants	212865 Participants n=446645 Participants	740875 Participants n=1390293 Participants
Age, Customized 80-90 years	321396 Participants n=943648 Participants	149231 Participants n=446645 Participants	470627 Participants n=1390293 Participants
Age, Customized >=90 years	94242 Participants n=943648 Participants	84549 Participants n=446645 Participants	178791 Participants n=1390293 Participants
Sex: Female, Male Female	415404 Participants n=943648 Participants	219829 Participants n=446645 Participants	635233 Participants n=1390293 Participants
Sex: Female, Male Male	528244 Participants n=943648 Participants	226816 Participants n=446645 Participants	755060 Participants n=1390293 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Incidence rate was defined as the number of events occurring during the follow-up period divided by the number of person-years of follow-up (sum of durations of follow-up period for incident participants). Incidence rate of stroke (ischemic or hemorrhage) in non-valvular AF participants who were exposed to OAC or unexposed to OAC were reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=505597 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=556876 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Incidence Rate (Per 1000 Participant-years) of Stroke in Non-valvular Atrial Fibrillation (AF) Participants Exposed to Oral Anticoagulation (OAC) and Unexposed to OAC	31.2 Events per 1000 person years Interval 30.7 to 31.6	14.7 Events per 1000 person years Interval 14.4 to 15.0

PRIMARY outcome

Timeframe: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Incidence rate was defined as the number of events occurring during the follow-up period divided by the number of person-years of follow-up (sum of durations of follow-up period for incident participants). Incidence rate of major bleeding in non-valvular AF participants who were exposed to OAC or unexposed to OAC were reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=503300 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=560862 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Incidence Rate (Per 1000 Participant-years) of Major Bleeding in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC	23.6 Events per 1000 person years Interval 23.2 to 24.0	21.5 Events per 1000 person years Interval 21.2 to 21.9

PRIMARY outcome

Timeframe: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Incidence rate was defined as the number of events occurring during the follow-up period divided by the number of person-years of follow-up (sum of durations of follow-up period for incident participants). Incidence rate of death in non-valvular AF participants who were exposed to OAC or unexposed to OAC were reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=509072 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=562241 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Incidence Rate (Per 1000 Participant-years) of Death in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC	184.6 Events per 1000 person years Interval 183.6 to 185.7	41.1 Events per 1000 person years Interval 40.7 to 41.6

PRIMARY outcome

Timeframe: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Contraindications included end-stage renal disease on dialysis, diseases of the blood and blood-forming organs, certain disorders involving the immune mechanism, recent history of acute bleeding gastric or duodenal ulcer, hepatic cirrhosis or fibrosis or liver failure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Number of Participants With Contraindications to OAC at Index Date in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC	86646 Participants	49478 Participants

PRIMARY outcome

Timeframe: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

A participant was considered to have received CMU-c if the participant benefitted from an exemption from care on the grounds of CMU-c for care received on the index date. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Number of Participants Who Received Complimentary Universal Health Care (CMU-c) in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC	10198 Participants	12819 Participants

PRIMARY outcome

Timeframe: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

A participant was considered to have received ACS if the participant benefitted from an aid for complementary health care on the index date. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Number of Participants Who Received Aid for Complementary Health Care (ACS) for Elderly Participants in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC	8698 Participants	10444 Participants

PRIMARY outcome

Timeframe: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Area of residence was derived based on the code of the department of residence recorded with health cares carried out on index date. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC Grand-Est	30014 Participants	43950 Participants
Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC Hauts-de-France	30567 Participants	44740 Participants
Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC Ile de France	45815 Participants	62389 Participants
Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC Normandie	16507 Participants	26059 Participants
Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC Nouvelle Aquitaine	33123 Participants	51529 Participants
Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC Occitanie	30580 Participants	47963 Participants
Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC Overseas districts and territories	135 Participants	281 Participants
Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC Unknown	21098 Participants	11562 Participants
Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC Auvergne-Rhône-Alpes	34422 Participants	56168 Participants
Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC Bourgogne-Franche-Comté	13849 Participants	24185 Participants
Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC Bretagne	15574 Participants	25892 Participants
Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC Centre-Val de Loire	14146 Participants	19626 Participants
Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC Corse	1829 Participants	2689 Participants
Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC Pays de la Loire	16155 Participants	25684 Participants
Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC Provence-Alpes-Côte d Azur	28422 Participants	42929 Participants

PRIMARY outcome

Timeframe: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Congestive heart failure, hypertension, age (\>65 = 1 point, \>75 = 2 points), diabetes, previous stroke/transient ischemic attack (2 points) (CHA2DS2)-vascular disease and sex category (VASc) scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age \>=75 years, sex category, congestive heart failure history, hypertension history, stroke/transient ischemic attack/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke, higher scores indicated higher risk of stroke and systemic emboli. Index date was date of first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Number of Participants Classified as Per Modified CHA2DS2-VASc Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC High	281168 Participants	402191 Participants
Number of Participants Classified as Per Modified CHA2DS2-VASc Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC Moderate	30413 Participants	57481 Participants
Number of Participants Classified as Per Modified CHA2DS2-VASc Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC Low	20655 Participants	25974 Participants

PRIMARY outcome

Timeframe: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age \>65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and \>=3 = high risk of bleed, higher scores indicated more risk of bleeds. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
HAS-BLED Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC	2.5 Units on a scale Standard Deviation 1.10	2.26 Units on a scale Standard Deviation 0.99

PRIMARY outcome

Timeframe: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Type of stroke was considered "Yes" if the participant was hospitalized with any discharge diagnosis (i.e., main and related diagnosis) of stroke (ischemic or hemorrhagic). Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=48252 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=38623 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Number of Participants Classified as Per Type of Stroke in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC Both Ischemic and haemorrhagic	5614 Participants	1285 Participants
Number of Participants Classified as Per Type of Stroke in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC Hemorrhagic	3996 Participants	1025 Participants
Number of Participants Classified as Per Type of Stroke in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC Ischemic	38642 Participants	36313 Participants

PRIMARY outcome

Timeframe: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Participants at risk of falls were identified by an algorithm adapted to SNDS data. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Number of Participants With Risk of Falls in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC	170465 Participants	186288 Participants

PRIMARY outcome

Timeframe: Up to 1 year prior to index date (index date was anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Participant was considered polymedicated if the participant had reimbursements for greater than or equal to (\>=) 5 different medications (different Anatomical Therapeutic Chemical codes \[ATC\] in the year before the index date. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Number of Participants Who Were Polymedicated in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC	291508 Participants	408403 Participants

PRIMARY outcome

Timeframe: Up to 2 years prior to index date (index date was anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Participant was considered to have at least one visit to nursing home if the participant had at least one reimbursement corresponding to a nursing home on or in the 2 years prior to the index date. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Number of Participants With Atleast One Visit to Nursing Home in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC	31493 Participants	16170 Participants

PRIMARY outcome

Timeframe: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

CCI based on various comorbid conditions such as myocardial infarction, congestive heart failure (CHF), peripheral vascular disease, cerebrovascular disease, dementia, chronic obstructive pulmonary disease, rheumatologic disease, peptic ulcer disease, mild liver disease, diabetes (mild to moderate), diabetes + complications, hemiplegia or paraplegia, renal disease, any malignancy (lymphoma and leukemia), moderate/severe liver disease, metastatic solid tumor, and acquired immune deficiency syndrome (AIDS) were reported. The comorbidities were assessed with different weights (from 1 to 6), and the total score was determined by adding the scores of each comorbidity. CCI score range was from 0 to 14, where 0= low comorbid condition and 14= high comorbid condition, higher scores= more comorbidity. Index date = date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Age Adjusted Charlson Comorbidity Index (CCI) in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC	3.6 Units on a scale Standard Deviation 3.51	2.32 Units on a scale Standard Deviation 2.06

PRIMARY outcome

Timeframe: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

The number of participants classified as per comorbidities (coronary arterial diseases, vascular and neurodegenerative dementia, myocardial infarction, congestive heart failure, peripheral arterial disease, other vascular diseases, sleep disorders, active cancer, malnutrition, morbid obesity, anemia, chronic obstructive pulmonary disease, diabetes, diabetes with complication, connective tissue disease, ulcer disease, cerebrovascular disease, cerebrovascular disease, mild liver disease, moderate-to-severe liver disease, hemiplegia) in non-valvular AF participants who were exposed to OAC and unexposed to OAC were reported in this outcome measure. One participant could have more than one comorbidity. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Coronary arterial diseases	75022 Participants	86531 Participants
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Vascular and neurodegenerative dementia	46852 Participants	23398 Participants
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Myocardial infarction	8689 Participants	12063 Participants
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Congestive heart failure	75117 Participants	87559 Participants
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Peripheral arterial disease	30313 Participants	24219 Participants
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Other vascular diseases	10216 Participants	7843 Participants
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Sleep disorders	16376 Participants	18149 Participants
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Active cancer	86281 Participants	75261 Participants
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Malnutrition	78027 Participants	34650 Participants
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Morbid obesity	34823 Participants	41052 Participants
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Anemia	30332 Participants	14756 Participants
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Chronic obstructive pulmonary disease	3942 Participants	2654 Participants
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Diabetes	67412 Participants	99628 Participants
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Diabetes with complication	1322 Participants	1165 Participants
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Connective tissue disease	6960 Participants	8376 Participants
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Ulcer disease	6211 Participants	2691 Participants
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Cerebrovascular disease	58186 Participants	48715 Participants
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Moderate-to-severe renal disease	42083 Participants	29846 Participants
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Mild liver disease	10801 Participants	7183 Participants
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Moderate-to-severe liver disease	4234 Participants	1551 Participants
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Hemiplegia	8159 Participants	4761 Participants

SECONDARY outcome

Timeframe: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Concomitant treatments included beta-blockers, antihypertensives, antiplatelet drugs, other anticoagulants(heparin, other antithrombotic agents, direct thrombin inhibitors\[except dabigatran\]),non-steroidal anti-inflammatory drugs(NSAIDs), oral corticoids, proton pump inhibitors, selective serotonin reuptake inhibitor antidepressants(SSRIs),systemic azole antifungals, other cytochrome P(CYP) P450 3A4 inhibitors(ticagrelor, diltiazem, verapamil, amiodarone, macrolide \[except spiramycine\]),medical procedure of cardioversion, digitalis glycosides, nitrates derivatives, benzodiazepines, lipid-lowering drugs, glucose-lowering drugs, antiarrhythmics. One participant could receive more than one concomitant treatment. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Glucose-lowering drugs	54691 Participants	91864 Participants
Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Lipid-lowering drugs	104804 Participants	195863 Participants
Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Digitalis glycosides	5392 Participants	20783 Participants
Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Nitrate derivatives	17315 Participants	23082 Participants
Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Benzodiazepines	97568 Participants	127625 Participants
Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Beta-blockers	124236 Participants	330710 Participants
Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Antihypertensives	198727 Participants	354602 Participants
Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Antiplatelet drugs	150062 Participants	206611 Participants
Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Other anticoagulants	32487 Participants	30265 Participants
Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC NSAIDs	40497 Participants	69466 Participants
Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Oral corticoids	52102 Participants	73061 Participants
Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Proton pump inhibitors	143103 Participants	215924 Participants
Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC SSRIs	32378 Participants	37035 Participants
Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Systemic azole antifungals	3948 Participants	3104 Participants
Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Protease inhibitors	97 Participants	109 Participants
Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Other CYP P450 3A4 inhibitors	55864 Participants	190900 Participants
Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Medical procedure of cardioversion	2603 Participants	6317 Participants
Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC Antiarrhythmics	61093 Participants	204717 Participants

SECONDARY outcome

Timeframe: Anytime in 2016, 2017, 2018 and 2019; retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: All AF incident participants included participants with/without OAC treatments before the index date. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.

Annual incidence rate of AF was calculated as the number of newly diagnosed non-valvular AF incidents to the number of inhabitants aged \>=18 years in France at risk of AF, in the corresponding year. Incidence rate of AF according to the corresponding year is reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=91946 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=224490 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Annual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC 2016	1.75 New cases per 1000 persons Interval 1.74 to 1.76	4.31 New cases per 1000 persons Interval 4.29 to 4.33
Annual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC 2017	1.59 New cases per 1000 persons Interval 1.58 to 1.6	4.13 New cases per 1000 persons Interval 4.12 to 4.15
Annual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC 2018	1.38 New cases per 1000 persons Interval 1.37 to 1.39	3.86 New cases per 1000 persons Interval 3.85 to 3.88
Annual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC 2019	1.22 New cases per 1000 persons Interval 1.21 to 1.23	3.73 New cases per 1000 persons Interval 3.71 to 3.74

SECONDARY outcome

Timeframe: Anytime in 2016, 2017, 2018 and 2019; retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Prevalent AF participants included participants diagnosed with AF during the historical period of two years before the index date. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.

Annual prevalence of non-valvular AF was defined as the number of diagnosed non-valvular atrial fibrillation (NVAF) participants to the number of inhabitants aged \>=18 years in France, in the corresponding year (National Institute for Statistics and Economic Studies \[INSEE\] data). Prevalence of AF according to the corresponding year is reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=438600 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=1141152 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Annual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC 2016	0.53 Prevalent cases per 1000 years Interval 0.53 to 0.53	1.50 Prevalent cases per 1000 years Interval 1.49 to 1.5
Annual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC 2017	0.65 Prevalent cases per 1000 years Interval 0.65 to 0.66	1.76 Prevalent cases per 1000 years Interval 1.76 to 1.77
Annual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC 2018	0.75 Prevalent cases per 1000 years Interval 0.74 to 0.75	1.97 Prevalent cases per 1000 years Interval 1.96 to 1.97
Annual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC 2019	0.82 Prevalent cases per 1000 years Interval 0.82 to 0.82	2.13 Prevalent cases per 1000 years Interval 2.13 to 2.14

SECONDARY outcome

Timeframe: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed (N)'' signifies participants evaluable for this outcome measure.

Participants were considered as new users of OAC and VKA if the participant received at least one reimbursement of an OAC (VKA, apixaban, rivaroxaban or dabigatran) during the inclusion period, without use of any OAC in the 24 months prior to the first date of OAC delivery. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=395461 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=601998 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Number of Participants Who Were New Users of OAC and VKA	0 Participants	421313 Participants

SECONDARY outcome

Timeframe: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, "N"=participants evaluable for this outcome measure who received at least one sequence of treatment. As pre-specified in protocol this outcome measure was planned to be analyzed only in participants exposed to OACs.

Number of participants according to number of treatment sequence (only one sequence of treatment, at least two sequences of treatment) is reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=572290 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Number of Participants According to Number of Treatment Sequence At least two sequences of treatment	—	120751 Participants
Number of Participants According to Number of Treatment Sequence Only one sequence of treatment	—	451539 Participants

SECONDARY outcome

Timeframe: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, "N"= participants evaluable for this outcome measure who received at least one sequence of treatment. As pre-specified in protocol this outcome measure was planned to be analyzed only in participants exposed to OACs.

Duration of each sequence of OAC treatment (i.e., at least one sequence of OAC treatment and at least two sequences of OAC treatment) for the participants who were exposed to OAC were reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=572290 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Duration of Each Sequence of OAC Treatment At least one sequence of treatment	—	9.5 Months Interval 2.8 to 22.3
Duration of Each Sequence of OAC Treatment At least two sequences of treatment	—	6.9 Months Interval 2.4 to 15.5

SECONDARY outcome

Timeframe: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, "N"= participants evaluable for this outcome measure who received at least one sequence of treatment. As pre-specified in protocol this outcome measure was planned to be analyzed only in participants exposed to OACs.

The number of participants with treatment switch who were exposed to OAC were reported in this outcome measure. Treatment switch was categorized into following categories: at least one sequence of treatment and at least two sequences of treatment. At least one sequence of treatment was defined as one or more OAC was given, and at least two sequences of treatment was defined as two or more OACs were given. Participants were considered to have treatment switch if the participant had at least one reimbursement of a OAC different from the first OAC delivered. Index date was the date of the first dispensation of OAC for participants exposed to OAC.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=572290 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Number of Participants With Treatment Switch of OAC Treatment At least one sequence of treatment	—	48101 Participants
Number of Participants With Treatment Switch of OAC Treatment At least two sequences of treatment	—	8592 Participants

SECONDARY outcome

Timeframe: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, "N"= participants evaluable for this outcome measure who received at least one sequence of treatment. As pre-specified in protocol this outcome measure was planned to be analyzed only in participants exposed to OACs.

Participants were considered to have temporary or permanent discontinuation if the participant had at least 60 days without reimbursement of an OAC after the date of the first OAC delivery. The number of participants with temporary or permanent discontinuation of OAC who were exposed to OAC were reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC. At least one sequence of treatment was defined as one or more OAC was given, and at least two sequences of treatment was defined as two or more OACs were given.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=572290 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Number of Participants With Temporary or Permanent Treatment Discontinuation of OAC At least one sequence of treatment	—	167099 Participants
Number of Participants With Temporary or Permanent Treatment Discontinuation of OAC At least two sequences of treatment	—	40849 Participants

SECONDARY outcome

Timeframe: At index date (anytime in between 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure. As pre-specified in protocol this outcome measure was planned to be analyzed only in participants exposed to OACs.

The number of participants classified according to type of OAC delivery (apixaban, rivaroxaban, VKA, dabigatran) who were exposed to OAC were reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Number of Participants Classified According to Type of OAC Delivery for Participants Exposed to OACs Apixaban	—	245094 Participants
Number of Participants Classified According to Type of OAC Delivery for Participants Exposed to OACs Rivaroxaban	—	151288 Participants
Number of Participants Classified According to Type of OAC Delivery for Participants Exposed to OACs VKA	—	56632 Participants
Number of Participants Classified According to Type of OAC Delivery for Participants Exposed to OACs Dabigatran	—	32632 Participants

SECONDARY outcome

Timeframe: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, "N"= participants evaluable for this outcome measure who received at least one sequence of treatment. As pre-specified in protocol this outcome measure was planned to be analyzed only in participants exposed to OACs.

Specialty of prescriber in participants who were exposed to OAC were reported in this outcome measure. Categories included hospital-based physician, generalist practitioners, city cardiologist, other and not specified. Index date was the date of the first dispensation of OAC for participants exposed to OAC. At least one sequence of treatment was defined as one or more OAC was given, and at least two sequences of treatment was defined as two or more OACs were given.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=572290 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC At least one sequence of treatment · Hospital-based physician	—	222102 Participants
Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC At least one sequence of treatment · Generalist practitioners	—	100629 Participants
Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC At least one sequence of treatment · City cardiologist	—	134893 Participants
Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC At least one sequence of treatment · Other	—	114252 Participants
Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC At least one sequence of treatment · Not specified	—	414 Participants
Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC At least two sequences of treatment · Hospital-based physician	—	27905 Participants
Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC At least two sequences of treatment · Generalist practitioners	—	49635 Participants
Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC At least two sequences of treatment · City cardiologist	—	19714 Participants
Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC At least two sequences of treatment · Other	—	23300 Participants
Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC At least two sequences of treatment · Not specified	—	197 Participants

SECONDARY outcome

Timeframe: From 6 to 12 months before the first stroke (anytime during 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Mean number of hospital stays with and without emergency visit per participant per month from 6 to 12 months before the first stroke who were exposed to OAC and unexposed to OAC were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Hospital Stays Per Participant Per Month Before the First Stroke From 6 to 12 Months	0.2 Hospital stays per participant per month Standard Deviation 0.88	0.2 Hospital stays per participant per month Standard Deviation 0.96

SECONDARY outcome

Timeframe: From 6 to 12 months before the first stroke (anytime during 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Outpatient visits including physicians visits (private practice and home), paramedic visits in community setting, public hospital outpatient visits (management services organization \[MSO\] and rehabilitation care facilities) are reported. Mean number of outpatient visits per participant per month from 6 to 12 months before the first stroke who were exposed to OAC and unexposed to OAC were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Outpatient Visits Per Participant Per Month Before the First Stroke From 6 to 12 Months Physicians visits (private practice and home)	1.0 Visits per participant per month Standard Deviation 0.87	1.1 Visits per participant per month Standard Deviation 0.86
Mean Number of Outpatient Visits Per Participant Per Month Before the First Stroke From 6 to 12 Months Paramedic visits in community setting	20.3 Visits per participant per month Standard Deviation 30.11	29.7 Visits per participant per month Standard Deviation 38.63
Mean Number of Outpatient Visits Per Participant Per Month Before the First Stroke From 6 to 12 Months Public hospital outpatient visits (MSO and rehabilitation care facilities)	0.1 Visits per participant per month Standard Deviation 0.32	0.2 Visits per participant per month Standard Deviation 0.39

SECONDARY outcome

Timeframe: From 6 to 12 months before the first stroke (anytime during 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Mean number of laboratory tests per participant per month from 6 to 12 months before the first stroke who were exposed to OAC and unexposed to OAC were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Laboratory Tests Per Participant Per Month (PPPM) Before the First Stroke From 6 to 12 Months	0.5 Laboratory tests PPPM Standard Deviation 0.85	1.0 Laboratory tests PPPM Standard Deviation 1.42

SECONDARY outcome

Timeframe: From 6 to 12 months before the first stroke (anytime during 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Mean number of medical procedures per participant per month from 6 to 12 months before the first stroke who were exposed to OAC and unexposed to OAC were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Medical Procedures Per Participant Per Month Before the First Stroke From 6 to 12 Months	0.5 Procedures per participant per month Standard Deviation 0.68	0.5 Procedures per participant per month Standard Deviation 0.63

SECONDARY outcome

Timeframe: From 6 to 12 months before the first stroke (anytime during 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Mean number of reimbursed transports per participant per month from 6 to 12 months before the first stroke who were exposed to OAC and unexposed to OAC were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Reimbursed Transports Per Participant Per Month Before the First Stroke From 6 to 12 Months	0.3 Transport per participant per month Standard Deviation 0.92	0.4 Transport per participant per month Standard Deviation 0.99

SECONDARY outcome

Timeframe: From 6 to 12 months before the first stroke (anytime during 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Mean number of drugs dispensed per participant per month from 6 to 12 months before the first stroke who were exposed to OAC and unexposed to OAC were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Drugs Dispensed Per Participant Per Month Before the First Stroke From 6 to 12 Months	9.1 Drugs dispensed PPPM Standard Deviation 7.72	11.6 Drugs dispensed PPPM Standard Deviation 7.44

SECONDARY outcome

Timeframe: From 6 to 12 months before the first stroke (anytime during 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Mean number of medical devices dispensed per participant per month from 6 to 12 months before the first stroke who were exposed to OAC and unexposed to OAC were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Medical Devices Dispensed Per Participant Per Month Before the First Stroke From 6 to 12 Months	0.6 Medical devices dispensed PPPM Standard Deviation 1.11	0.8 Medical devices dispensed PPPM Standard Deviation 1.29

SECONDARY outcome

Timeframe: From 6 to 12 months after the first stroke (anytime during 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Mean number of hospital stays per participant per month from 6 to 12 months after the first stroke who were exposed to OAC and unexposed to OAC were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Hospital Stays Per Participant Per Month After the First Stroke From 6 to 12 Months	0.3 Hospital stays per participant per month Standard Deviation 1.64	0.2 Hospital stays per participant per month Standard Deviation 1.04

SECONDARY outcome

Timeframe: From 6 to 12 months after the first stroke (anytime during 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Outpatient visits included physicians visits (private practice and home), paramedic visits in community setting and public hospital outpatient visits (MSO and rehabilitation care facilities). Mean number of outpatient visits per participant per month from 6 to 12 months after the first stroke who were exposed to OAC and unexposed to OAC were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Outpatient Visits Per Participant Per Month After the First Stroke From 6 to 12 Months Physicians visits (private practice and home)	0.9 Visits per participant per month Standard Deviation 1.18	1.0 Visits per participant per month Standard Deviation 1.01
Mean Number of Outpatient Visits Per Participant Per Month After the First Stroke From 6 to 12 Months Paramedic visits in community setting	29.4 Visits per participant per month Standard Deviation 43.55	35.3 Visits per participant per month Standard Deviation 44.24
Mean Number of Outpatient Visits Per Participant Per Month After the First Stroke From 6 to 12 Months Public hospital outpatient visits (MSO and rehabilitation care facilities)	0.2 Visits per participant per month Standard Deviation 0.40	0.2 Visits per participant per month Standard Deviation 0.38

SECONDARY outcome

Timeframe: From 6 to 12 months after the first stroke (anytime during 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Mean number of laboratory tests per participant per month from 6 to 12 months after the first stroke who were exposed to OAC and unexposed to OAC were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Laboratory Tests Per Participant Per Month After the First Stroke From 6 to 12 Months	0.6 Laboratory tests PPPM Standard Deviation 1.21	0.9 Laboratory tests PPPM Standard Deviation 1.48

SECONDARY outcome

Timeframe: From 6 to 12 months after the first stroke (anytime during 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Mean number of outpatient medical procedures per participant per month from 6 to 12 months after the first stroke who were exposed to OAC and unexposed to OAC were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Outpatient Medical Procedures Per Participant Per Month of HCRU After the First Stroke From 6 to 12 Months	0.4 Procedures per participant per month Standard Deviation 0.73	0.5 Procedures per participant per month Standard Deviation 0.70

SECONDARY outcome

Timeframe: From 6 to 12 months after the first stroke (anytime during 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Mean number of reimbursed transports per participant per month from 6 to 12 months after the first stroke who were exposed to OAC and unexposed to OAC were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Reimbursed Transports Per Participant Per Month of HCRU After the First Stroke From 6 to 12 Months	0.6 Transport per participant per month Standard Deviation 1.48	0.5 Transport per participant per month Standard Deviation 1.20

SECONDARY outcome

Timeframe: From 6 to 12 months after the first stroke (anytime during 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Mean number of drugs dispensed per participant per month of HCRU from 6 to 12 months after the first stroke who were exposed to OAC and unexposed to OAC were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Drugs Dispensed Per Participant Per Month After the First Stroke From 6 to 12 Months	9.2 Drugs dispensed PPPM Standard Deviation 10.43	11.9 Drugs dispensed PPPM Standard Deviation 10.66

SECONDARY outcome

Timeframe: From 6 to 12 months after the first stroke (anytime during 01-Jan-2016 and 31-Dec-2019); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Mean number of medical devices dispensed per participant per month of HCRU from 6 to 12 months after the first stroke who were exposed to OAC and unexposed to OAC were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Medical Devices Dispensed Per Participant Per Month After the First Stroke From 6 to 12 Months	1.0 Medical devices dispensed PPPM Standard Deviation 1.97	1.0 Medical devices dispensed PPPM Standard Deviation 1.88

SECONDARY outcome

Timeframe: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Hospitalization cost (Euros per participant per month) in participants who were exposed to and unexposed to OAC were reported in this outcome measure. Cost equals to the value of cost (i.e. including reimbursed and non-reimbursed amounts) indicated in the data extraction and associated with the reimbursement. All cost was calculated per participant per month (PPPM). Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Hospitalization Cost in Participants Exposed to and Unexposed to OAC	1318.5 Euros per participant per month Standard Deviation 32665.57	434.1 Euros per participant per month Standard Deviation 1885.73

SECONDARY outcome

Timeframe: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population. Here, ''Overall number of participants analysed'' signifies participants evaluable for this outcome measure. All participants reported under 'N' contributed data to the table; however, may not have evaluable data for each row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.

Medical procedures and blood examination cost (Euros per participant per month) in participants who were exposed to and unexposed to OAC were reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study. Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=309834 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=413397 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Medical Procedures and Blood Examination Cost in Participants Exposed to and Unexposed to OAC Outpatient medical procedures (public and private settings)	28.2 Euros per participant per month Standard Deviation 162.60	33.1 Euros per participant per month Standard Deviation 101.54
Medical Procedures and Blood Examination Cost in Participants Exposed to and Unexposed to OAC Blood examination	11.2 Euros per participant per month Standard Deviation 31.92	14.3 Euros per participant per month Standard Deviation 24.54

SECONDARY outcome

Timeframe: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.

Mean number of hospital stays per month for participants who were exposed to OAC and unexposed to OAC were reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study. Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=135673 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=183966 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Hospital Stays Per Month MSO hospital stays with and without emergency visit (public and private settings)	0.4 Hospital stays per month Standard Deviation 1.77	0.2 Hospital stays per month Standard Deviation 1.00
Mean Number of Hospital Stays Per Month MSO hospital stays starting with emergency visit (public and private settings)	0.1 Hospital stays per month Standard Deviation 0.46	0.0 Hospital stays per month Standard Deviation 0.27
Mean Number of Hospital Stays Per Month Hospital stays in rehabilitation care facilities	0.0 Hospital stays per month Standard Deviation 0.52	0.0 Hospital stays per month Standard Deviation 0.07
Mean Number of Hospital Stays Per Month MSO hospital stays with palliative care (public and private settings)	0.0 Hospital stays per month Standard Deviation 0.40	0.0 Hospital stays per month Standard Deviation 0.08

SECONDARY outcome

Timeframe: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Mean number of emergency visits per month for participants who were exposed to OAC and unexposed to OAC were reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=50666 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=72022 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Emergency Visits Per Month	0.0 Emergency visits per month Standard Deviation 0.20	0.0 Emergency visits per month Standard Deviation 0.23

SECONDARY outcome

Timeframe: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Mean number of physician visits for participants who were exposed to OAC and unexposed to OAC were reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=248409 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=400299 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Physician Visits	0.8 Physician visits Standard Deviation 1.04	1.0 Physician visits Standard Deviation 1.08

SECONDARY outcome

Timeframe: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Mean number of public hospital outpatient visits for participants who were exposed to OAC and unexposed to OAC were reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=132843 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=195674 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Public Hospital Outpatient Visits	0.2 Outpatient visits Standard Deviation 0.42	0.2 Outpatient visits Standard Deviation 0.44

SECONDARY outcome

Timeframe: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Mean number of paramedic visits in community setting for participants who were exposed to OAC and unexposed to OAC were reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=265667 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=413083 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Paramedic Visits in Community Setting	23.4 Paramedic visits Standard Deviation 38.22	28.8 Paramedic visits Standard Deviation 36.21

SECONDARY outcome

Timeframe: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Mean number of laboratory tests for participants who were exposed to OAC and unexposed to OAC were reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=214065 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=369569 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Laboratory Tests	0.5 Laboratory tests Standard Deviation 1.15	0.8 Laboratory tests Standard Deviation 1.31

SECONDARY outcome

Timeframe: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Mean number of outpatient medical procedures for participants who were exposed to OAC and unexposed to OAC were reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=221892 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=361232 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Outpatient Medical Procedures	0.5 Medical procedures Standard Deviation 0.86	0.6 Medical procedures Standard Deviation 0.93

SECONDARY outcome

Timeframe: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, "Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

Mean number of travels per month for participants who were exposed to OAC and unexposed to OAC were reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=127894 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=161349 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Mean Number of Travels Per Month	0.4 Travels per month Standard Deviation 1.32	0.3 Travels per month Standard Deviation 1.06

OTHER_PRE_SPECIFIED outcome

Timeframe: Follow up period: From index date until death, end of study or the date of last reimbursement of care recorded in the SNDS (maximum up to 48 months); retrospective data was retrieved and analyzed during approximately 9 months of this observational study

Population: Certain AF incident population included participants with a first AF diagnosis date during study period but without history of OACs delivery in the 24 months before inclusion date, with no reported events of interest (stroke, major bleeding) between inclusion and index date. Here, ''Overall number of participants analyzed'' signifies participants evaluable for this outcome measure.

The number of participants in subgroups (elderly \[\>=80 years\], non-elderly \[18 to \<80 years\], coronary artery disease, frail, cancer, previous stroke, high CHA₂DS₂-VASC) who were exposed to OAC and unexposed to OAC were reported in this outcome measure. Index date was the date of the first dispensation of OAC for participants exposed to OAC and for participants unexposed to OAC, index date was the date of inclusion in the study.

Outcome measures

Outcome measures
Measure	Participants Unexposed to OACs n=332236 Participants Participants with AF who were unexposed to OACs within 30 days after inclusion and were identified from SNDS between 01-Jan-2016 and 31-Dec-2019 were included.	Participants Exposed to OACs n=485646 Participants Participants with AF who were exposed to VKA or DOACs (including apixaban, rivaroxaban or dabigatran) within 30 days after inclusion and were identified from SNDS databases between 01-Jan-2016 and 31-Dec-2019 were included.
Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants Elderly (>=80 years)	170170 Participants	199562 Participants
Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants Non-elderly (18 to <80 years)	162066 Participants	286084 Participants
Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants Coronary artery disease	75022 Participants	86531 Participants
Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants Frail	120900 Participants	103521 Participants
Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants Active cancer	86281 Participants	75261 Participants
Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants Previous stroke	32268 Participants	48610 Participants
Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants High CHA2DS2-VASc	281168 Participants	402191 Participants

Adverse Events

Participants Exposed to OACs

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Participants Unexposed to OACs

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

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 publication 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