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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

SIFNOS STUDY: RETROSPECTIVE STUDY IN PATIENTS WITH ATRIAL FIBRILLATION (AF) EXPOSED AND UNEXPOSED TO AN ORAL ANTICOAGULANT THERAPY BETWEEN 2016-2020 IN FRANCE

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05838664
Acronym
SIFNOS
Enrollment
2140403
Registered
2023-05-01
Start date
2023-07-07
Completion date
2024-09-30
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief summary

The purpose of this study is to look at how many patients with AF had strokes, major bleeding and death in both people who had and had not taken any oral anticoagulant. Atrial fibrillation (AF) is an irregular and often very rapid heart rhythm (arrhythmia) that can lead to blood clots in the heart. This increases the risk of stroke. Anticoagulants are medicines, also called blood thinners, which help prevent blood clots from forming or getting bigger. This study includes patient's data from the database who: * Had at least one hospital stay with AF * Are new users of OACs for AF treatment * Are 18 years and older when they were confirmed to have AF All the patient's data included in this study would have either received the OAC therapy or not. This study aims to look at any events of strokes, major bleeding and death. The data of patients will be collected from the French national health insurance claims database (SNDS). The planned study period is thought to be from 1st January 2016 till 31st December 2020

Interventions

DRUGNo OAC

AF Patient who were not exposed to oral anticoagulation

DRUGVKA

AF patients who received VKA

DRUGapixaban

AF patients who received apixaban

DRUGrivaroxaban

AF patients who received rivaroxaban

DRUGdabigatran

AF patients who received dabigatran

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Identified patients with AF aged 18 years and older at diagnosis of AF

Exclusion criteria

* AF Patients with at least one hospital stays for associated valve disease or valve surgery * Patients treated with an OAC for another indication than AF

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACAt 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 studyThe 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.
Incidence Rate (Per 1000 Participant-years) of Stroke in Non-valvular Atrial Fibrillation (AF) Participants Exposed to Oral Anticoagulation (OAC) and Unexposed to OACFollow 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 studyIncidence 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.
Incidence Rate (Per 1000 Participant-years) of Major Bleeding in Non-valvular AF Participants Exposed to OAC and Unexposed to OACFollow 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 studyIncidence 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.
Incidence Rate (Per 1000 Participant-years) of Death in Non-valvular AF Participants Exposed to OAC and Unexposed to OACFollow 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 studyIncidence 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.
Number of Participants With Contraindications to OAC at Index Date in Non-valvular AF Participants Exposed to OAC and Unexposed to OACAt 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 studyContraindications 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.
Number of Participants Who Received Complimentary Universal Health Care (CMU-c) in Non-valvular AF Participants Exposed to OAC and Unexposed to OACAt 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 studyA 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.
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 OACAt 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 studyA 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.
Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACAt 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 studyArea 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.
Number of Participants Classified as Per Modified CHA2DS2-VASc Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OACAt 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 studyCongestive 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.
HAS-BLED Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OACAt 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 studyHAS-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.
Number of Participants Classified as Per Type of Stroke in Non-valvular AF Participants Exposed to OAC and Unexposed to OACAt 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 studyType 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.
Number of Participants With Risk of Falls in Non-valvular AF Participants Exposed to OAC and Unexposed to OACAt 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 studyParticipants 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.
Number of Participants Who Were Polymedicated in Non-valvular AF Participants Exposed to OAC and Unexposed to OACUp 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 studyParticipant 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.
Number of Participants With Atleast One Visit to Nursing Home in Non-valvular AF Participants Exposed to OAC and Unexposed to OACUp 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 studyParticipant 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.
Age Adjusted Charlson Comorbidity Index (CCI) in Non-valvular AF Participants Exposed to OAC and Unexposed to OACAt 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 studyCCI 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.

Secondary

MeasureTime frameDescription
Mean Number of Reimbursed Transports Per Participant Per Month Before the First Stroke From 6 to 12 MonthsFrom 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 studyMean 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.
Mean Number of Drugs Dispensed Per Participant Per Month Before the First Stroke From 6 to 12 MonthsFrom 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 studyMean 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.
Mean Number of Medical Devices Dispensed Per Participant Per Month Before the First Stroke From 6 to 12 MonthsFrom 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 studyMean 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.
Mean Number of Hospital Stays Per Participant Per Month After the First Stroke From 6 to 12 MonthsFrom 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 studyMean 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.
Mean Number of Outpatient Visits Per Participant Per Month After the First Stroke From 6 to 12 MonthsFrom 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 studyOutpatient 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.
Mean Number of Laboratory Tests Per Participant Per Month After the First Stroke From 6 to 12 MonthsFrom 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 studyMean 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.
Mean Number of Outpatient Medical Procedures Per Participant Per Month of HCRU After the First Stroke From 6 to 12 MonthsFrom 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 studyMean 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.
Mean Number of Reimbursed Transports Per Participant Per Month of HCRU After the First Stroke From 6 to 12 MonthsFrom 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 studyMean 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.
Mean Number of Drugs Dispensed Per Participant Per Month After the First Stroke From 6 to 12 MonthsFrom 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 studyMean 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.
Mean Number of Medical Devices Dispensed Per Participant Per Month After the First Stroke From 6 to 12 MonthsFrom 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 studyMean 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.
Hospitalization Cost in Participants Exposed to and Unexposed to OACFollow 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 studyHospitalization 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.
Medical Procedures and Blood Examination Cost in Participants Exposed to and Unexposed to OACFollow 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 studyMedical 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.
Mean Number of Hospital Stays Per MonthFollow 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 studyMean 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.
Mean Number of Emergency Visits Per MonthFollow 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 studyMean 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.
Mean Number of Physician VisitsFollow 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 studyMean 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.
Mean Number of Public Hospital Outpatient VisitsFollow 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 studyMean 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.
Mean Number of Laboratory TestsFollow 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 studyMean 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.
Mean Number of Outpatient Medical ProceduresFollow 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 studyMean 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.
Mean Number of Travels Per MonthFollow 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 studyMean 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.
Mean Number of Paramedic Visits in Community SettingFollow 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 studyMean 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.
Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACAt 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 studyConcomitant 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.
Annual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OACAnytime in 2016, 2017, 2018 and 2019; retrospective data was retrieved and analyzed during approximately 9 months of this observational studyAnnual 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.
Annual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OACAnytime in 2016, 2017, 2018 and 2019; retrospective data was retrieved and analyzed during approximately 9 months of this observational studyAnnual 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.
Number of Participants Who Were New Users of OAC and VKAAt 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 studyParticipants 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.
Number of Participants According to Number of Treatment SequenceFollow 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 studyNumber 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.
Duration of Each Sequence of OAC TreatmentFollow 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 studyDuration 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.
Number of Participants With Treatment Switch of OAC TreatmentFollow 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 studyThe 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.
Number of Participants With Temporary or Permanent Treatment Discontinuation of OACFollow 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 studyParticipants 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.
Number of Participants Classified According to Type of OAC Delivery for Participants Exposed to OACsAt 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 studyThe 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.
Number of Participants According to Speciality of Prescriber for Participant Exposed to OACFollow 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 studySpecialty 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.
Mean Number of Hospital Stays Per Participant Per Month Before the First Stroke From 6 to 12 MonthsFrom 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 studyMean 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.
Mean Number of Outpatient Visits Per Participant Per Month Before the First Stroke From 6 to 12 MonthsFrom 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 studyOutpatient 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.
Mean Number of Laboratory Tests Per Participant Per Month (PPPM) Before the First Stroke From 6 to 12 MonthsFrom 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 studyMean 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.
Mean Number of Medical Procedures Per Participant Per Month Before the First Stroke From 6 to 12 MonthsFrom 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 studyMean 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.

Other

MeasureTime frameDescription
Number of Participants According to Subgroups in OAC Exposed and Unexposed ParticipantsFollow 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 studyThe 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.

Countries

France

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
Participants Exposed to OACs
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.
943,648
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.
446,645
Total1,390,293

Baseline characteristics

CharacteristicParticipants Exposed to OACsParticipants Unexposed to OACsTotal
Age, Customized
80-90 years
321396 Participants149231 Participants470627 Participants
Age, Customized
<80 years
528010 Participants212865 Participants740875 Participants
Age, Customized
>=90 years
94242 Participants84549 Participants178791 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
415404 Participants219829 Participants635233 Participants
Sex: Female, Male
Male
528244 Participants226816 Participants755060 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Age Adjusted Charlson Comorbidity Index (CCI) in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsAge Adjusted Charlson Comorbidity Index (CCI) in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC2.32 Units on a scaleStandard Deviation 2.06
Participants Unexposed to OACsAge Adjusted Charlson Comorbidity Index (CCI) in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC3.6 Units on a scaleStandard Deviation 3.51
Primary

HAS-BLED Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsHAS-BLED Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC2.26 Units on a scaleStandard Deviation 0.99
Participants Unexposed to OACsHAS-BLED Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC2.5 Units on a scaleStandard Deviation 1.1
Primary

Incidence Rate (Per 1000 Participant-years) of Death in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

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.

Time frame: 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.

ArmMeasureValue (NUMBER)
Participants Exposed to OACsIncidence Rate (Per 1000 Participant-years) of Death in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC41.1 Events per 1000 person years
Participants Unexposed to OACsIncidence Rate (Per 1000 Participant-years) of Death in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC184.6 Events per 1000 person years
Primary

Incidence Rate (Per 1000 Participant-years) of Major Bleeding in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

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.

Time frame: 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.

ArmMeasureValue (NUMBER)
Participants Exposed to OACsIncidence Rate (Per 1000 Participant-years) of Major Bleeding in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC21.5 Events per 1000 person years
Participants Unexposed to OACsIncidence Rate (Per 1000 Participant-years) of Major Bleeding in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC23.6 Events per 1000 person years
Primary

Incidence Rate (Per 1000 Participant-years) of Stroke in Non-valvular Atrial Fibrillation (AF) Participants Exposed to Oral Anticoagulation (OAC) and Unexposed to OAC

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.

Time frame: 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.

ArmMeasureValue (NUMBER)
Participants Exposed to OACsIncidence Rate (Per 1000 Participant-years) of Stroke in Non-valvular Atrial Fibrillation (AF) Participants Exposed to Oral Anticoagulation (OAC) and Unexposed to OAC14.7 Events per 1000 person years
Participants Unexposed to OACsIncidence Rate (Per 1000 Participant-years) of Stroke in Non-valvular Atrial Fibrillation (AF) Participants Exposed to Oral Anticoagulation (OAC) and Unexposed to OAC31.2 Events per 1000 person years
Primary

Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

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.

Time frame: 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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Participants Exposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACPays de la Loire25684 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACUnknown11562 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACProvence-Alpes-Côte d Azur42929 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACAuvergne-Rhône-Alpes56168 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACBretagne25892 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACCentre-Val de Loire19626 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACCorse2689 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACOverseas districts and territories281 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACGrand-Est43950 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACHauts-de-France44740 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACIle de France62389 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACNormandie26059 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACNouvelle Aquitaine51529 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACOccitanie47963 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACBourgogne-Franche-Comté24185 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACIle de France45815 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACProvence-Alpes-Côte d Azur28422 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACOverseas districts and territories135 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACPays de la Loire16155 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACNouvelle Aquitaine33123 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACUnknown21098 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACGrand-Est30014 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACAuvergne-Rhône-Alpes34422 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACBourgogne-Franche-Comté13849 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACNormandie16507 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACBretagne15574 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACHauts-de-France30567 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACCentre-Val de Loire14146 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACOccitanie30580 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OACCorse1829 Participants
Primary

Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC

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.

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACAnemia14756 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACVascular and neurodegenerative dementia23398 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACChronic obstructive pulmonary disease2654 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACOther vascular diseases7843 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACDiabetes99628 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACCoronary arterial diseases86531 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACDiabetes with complication1165 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACSleep disorders18149 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACConnective tissue disease8376 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACMyocardial infarction12063 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACUlcer disease2691 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACActive cancer75261 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACCerebrovascular disease48715 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACMild liver disease7183 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACModerate-to-severe renal disease29846 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACMalnutrition34650 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACCongestive heart failure87559 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACModerate-to-severe liver disease1551 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACMorbid obesity41052 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACHemiplegia4761 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACPeripheral arterial disease24219 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACHemiplegia8159 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACCoronary arterial diseases75022 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACVascular and neurodegenerative dementia46852 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACMyocardial infarction8689 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACPeripheral arterial disease30313 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACOther vascular diseases10216 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACSleep disorders16376 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACActive cancer86281 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACMalnutrition78027 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACMorbid obesity34823 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACAnemia30332 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACChronic obstructive pulmonary disease3942 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACDiabetes67412 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACDiabetes with complication1322 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACConnective tissue disease6960 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACUlcer disease6211 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACCerebrovascular disease58186 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACModerate-to-severe renal disease42083 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACMild liver disease10801 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACModerate-to-severe liver disease4234 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACCongestive heart failure75117 Participants
Primary

Number of Participants Classified as Per Modified CHA2DS2-VASc Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

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.

Time frame: 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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Participants Exposed to OACsNumber of Participants Classified as Per Modified CHA2DS2-VASc Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OACHigh402191 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Modified CHA2DS2-VASc Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OACModerate57481 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Modified CHA2DS2-VASc Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OACLow25974 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Modified CHA2DS2-VASc Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OACHigh281168 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Modified CHA2DS2-VASc Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OACModerate30413 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Modified CHA2DS2-VASc Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OACLow20655 Participants
Primary

Number of Participants Classified as Per Type of Stroke in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

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.

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants Exposed to OACsNumber of Participants Classified as Per Type of Stroke in Non-valvular AF Participants Exposed to OAC and Unexposed to OACBoth Ischemic and haemorrhagic1285 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Type of Stroke in Non-valvular AF Participants Exposed to OAC and Unexposed to OACHemorrhagic1025 Participants
Participants Exposed to OACsNumber of Participants Classified as Per Type of Stroke in Non-valvular AF Participants Exposed to OAC and Unexposed to OACIschemic36313 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Type of Stroke in Non-valvular AF Participants Exposed to OAC and Unexposed to OACBoth Ischemic and haemorrhagic5614 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Type of Stroke in Non-valvular AF Participants Exposed to OAC and Unexposed to OACHemorrhagic3996 Participants
Participants Unexposed to OACsNumber of Participants Classified as Per Type of Stroke in Non-valvular AF Participants Exposed to OAC and Unexposed to OACIschemic38642 Participants
Primary

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

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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants Exposed to OACsNumber of Participants Who Received Aid for Complementary Health Care (ACS) for Elderly Participants in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC10444 Participants
Participants Unexposed to OACsNumber of Participants Who Received Aid for Complementary Health Care (ACS) for Elderly Participants in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC8698 Participants
Primary

Number of Participants Who Received Complimentary Universal Health Care (CMU-c) in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants Exposed to OACsNumber of Participants Who Received Complimentary Universal Health Care (CMU-c) in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC12819 Participants
Participants Unexposed to OACsNumber of Participants Who Received Complimentary Universal Health Care (CMU-c) in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC10198 Participants
Primary

Number of Participants Who Were Polymedicated in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants Exposed to OACsNumber of Participants Who Were Polymedicated in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC408403 Participants
Participants Unexposed to OACsNumber of Participants Who Were Polymedicated in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC291508 Participants
Primary

Number of Participants With Atleast One Visit to Nursing Home in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants Exposed to OACsNumber of Participants With Atleast One Visit to Nursing Home in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC16170 Participants
Participants Unexposed to OACsNumber of Participants With Atleast One Visit to Nursing Home in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC31493 Participants
Primary

Number of Participants With Contraindications to OAC at Index Date in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants Exposed to OACsNumber of Participants With Contraindications to OAC at Index Date in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC49478 Participants
Participants Unexposed to OACsNumber of Participants With Contraindications to OAC at Index Date in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC86646 Participants
Primary

Number of Participants With Risk of Falls in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC

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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants Exposed to OACsNumber of Participants With Risk of Falls in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC186288 Participants
Participants Unexposed to OACsNumber of Participants With Risk of Falls in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC170465 Participants
Secondary

Annual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
Participants Exposed to OACsAnnual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC20164.31 New cases per 1000 persons
Participants Exposed to OACsAnnual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC20174.13 New cases per 1000 persons
Participants Exposed to OACsAnnual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC20183.86 New cases per 1000 persons
Participants Exposed to OACsAnnual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC20193.73 New cases per 1000 persons
Participants Unexposed to OACsAnnual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC20191.22 New cases per 1000 persons
Participants Unexposed to OACsAnnual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC20161.75 New cases per 1000 persons
Participants Unexposed to OACsAnnual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC20181.38 New cases per 1000 persons
Participants Unexposed to OACsAnnual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC20171.59 New cases per 1000 persons
Secondary

Annual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
Participants Exposed to OACsAnnual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC20161.50 Prevalent cases per 1000 years
Participants Exposed to OACsAnnual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC20171.76 Prevalent cases per 1000 years
Participants Exposed to OACsAnnual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC20181.97 Prevalent cases per 1000 years
Participants Exposed to OACsAnnual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC20192.13 Prevalent cases per 1000 years
Participants Unexposed to OACsAnnual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC20190.82 Prevalent cases per 1000 years
Participants Unexposed to OACsAnnual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC20160.53 Prevalent cases per 1000 years
Participants Unexposed to OACsAnnual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC20180.75 Prevalent cases per 1000 years
Participants Unexposed to OACsAnnual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC20170.65 Prevalent cases per 1000 years
Secondary

Duration of Each Sequence of OAC Treatment

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.

Time frame: 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.

ArmMeasureGroupValue (MEDIAN)
Participants Exposed to OACsDuration of Each Sequence of OAC TreatmentAt least one sequence of treatment9.5 Months
Participants Exposed to OACsDuration of Each Sequence of OAC TreatmentAt least two sequences of treatment6.9 Months
Secondary

Hospitalization Cost in Participants Exposed to and Unexposed to OAC

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsHospitalization Cost in Participants Exposed to and Unexposed to OAC434.1 Euros per participant per monthStandard Deviation 1885.73
Participants Unexposed to OACsHospitalization Cost in Participants Exposed to and Unexposed to OAC1318.5 Euros per participant per monthStandard Deviation 32665.57
Secondary

Mean Number of Drugs Dispensed Per Participant Per Month After the First Stroke From 6 to 12 Months

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Drugs Dispensed Per Participant Per Month After the First Stroke From 6 to 12 Months11.9 Drugs dispensed PPPMStandard Deviation 10.66
Participants Unexposed to OACsMean Number of Drugs Dispensed Per Participant Per Month After the First Stroke From 6 to 12 Months9.2 Drugs dispensed PPPMStandard Deviation 10.43
Secondary

Mean Number of Drugs Dispensed Per Participant Per Month Before the First Stroke From 6 to 12 Months

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Drugs Dispensed Per Participant Per Month Before the First Stroke From 6 to 12 Months11.6 Drugs dispensed PPPMStandard Deviation 7.44
Participants Unexposed to OACsMean Number of Drugs Dispensed Per Participant Per Month Before the First Stroke From 6 to 12 Months9.1 Drugs dispensed PPPMStandard Deviation 7.72
Secondary

Mean Number of Emergency Visits Per Month

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Emergency Visits Per Month0.0 Emergency visits per monthStandard Deviation 0.23
Participants Unexposed to OACsMean Number of Emergency Visits Per Month0.0 Emergency visits per monthStandard Deviation 0.2
Secondary

Mean Number of Hospital Stays Per Month

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Hospital Stays Per MonthMSO hospital stays with and without emergency visit (public and private settings)0.2 Hospital stays per monthStandard Deviation 1
Participants Exposed to OACsMean Number of Hospital Stays Per MonthHospital stays in rehabilitation care facilities0.0 Hospital stays per monthStandard Deviation 0.07
Participants Exposed to OACsMean Number of Hospital Stays Per MonthMSO hospital stays with palliative care (public and private settings)0.0 Hospital stays per monthStandard Deviation 0.08
Participants Exposed to OACsMean Number of Hospital Stays Per MonthMSO hospital stays starting with emergency visit (public and private settings)0.0 Hospital stays per monthStandard Deviation 0.27
Participants Unexposed to OACsMean Number of Hospital Stays Per MonthMSO hospital stays with palliative care (public and private settings)0.0 Hospital stays per monthStandard Deviation 0.4
Participants Unexposed to OACsMean Number of Hospital Stays Per MonthHospital stays in rehabilitation care facilities0.0 Hospital stays per monthStandard Deviation 0.52
Participants Unexposed to OACsMean Number of Hospital Stays Per MonthMSO hospital stays with and without emergency visit (public and private settings)0.4 Hospital stays per monthStandard Deviation 1.77
Participants Unexposed to OACsMean Number of Hospital Stays Per MonthMSO hospital stays starting with emergency visit (public and private settings)0.1 Hospital stays per monthStandard Deviation 0.46
Secondary

Mean Number of Hospital Stays Per Participant Per Month After the First Stroke From 6 to 12 Months

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Hospital Stays Per Participant Per Month After the First Stroke From 6 to 12 Months0.2 Hospital stays per participant per monthStandard Deviation 1.04
Participants Unexposed to OACsMean Number of Hospital Stays Per Participant Per Month After the First Stroke From 6 to 12 Months0.3 Hospital stays per participant per monthStandard Deviation 1.64
Secondary

Mean Number of Hospital Stays Per Participant Per Month Before the First Stroke From 6 to 12 Months

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Hospital Stays Per Participant Per Month Before the First Stroke From 6 to 12 Months0.2 Hospital stays per participant per monthStandard Deviation 0.96
Participants Unexposed to OACsMean Number of Hospital Stays Per Participant Per Month Before the First Stroke From 6 to 12 Months0.2 Hospital stays per participant per monthStandard Deviation 0.88
Secondary

Mean Number of Laboratory Tests

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Laboratory Tests0.8 Laboratory testsStandard Deviation 1.31
Participants Unexposed to OACsMean Number of Laboratory Tests0.5 Laboratory testsStandard Deviation 1.15
Secondary

Mean Number of Laboratory Tests Per Participant Per Month After the First Stroke From 6 to 12 Months

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Laboratory Tests Per Participant Per Month After the First Stroke From 6 to 12 Months0.9 Laboratory tests PPPMStandard Deviation 1.48
Participants Unexposed to OACsMean Number of Laboratory Tests Per Participant Per Month After the First Stroke From 6 to 12 Months0.6 Laboratory tests PPPMStandard Deviation 1.21
Secondary

Mean Number of Laboratory Tests Per Participant Per Month (PPPM) Before the First Stroke From 6 to 12 Months

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Laboratory Tests Per Participant Per Month (PPPM) Before the First Stroke From 6 to 12 Months1.0 Laboratory tests PPPMStandard Deviation 1.42
Participants Unexposed to OACsMean Number of Laboratory Tests Per Participant Per Month (PPPM) Before the First Stroke From 6 to 12 Months0.5 Laboratory tests PPPMStandard Deviation 0.85
Secondary

Mean Number of Medical Devices Dispensed Per Participant Per Month After the First Stroke From 6 to 12 Months

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Medical Devices Dispensed Per Participant Per Month After the First Stroke From 6 to 12 Months1.0 Medical devices dispensed PPPMStandard Deviation 1.88
Participants Unexposed to OACsMean Number of Medical Devices Dispensed Per Participant Per Month After the First Stroke From 6 to 12 Months1.0 Medical devices dispensed PPPMStandard Deviation 1.97
Secondary

Mean Number of Medical Devices Dispensed Per Participant Per Month Before the First Stroke From 6 to 12 Months

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Medical Devices Dispensed Per Participant Per Month Before the First Stroke From 6 to 12 Months0.8 Medical devices dispensed PPPMStandard Deviation 1.29
Participants Unexposed to OACsMean Number of Medical Devices Dispensed Per Participant Per Month Before the First Stroke From 6 to 12 Months0.6 Medical devices dispensed PPPMStandard Deviation 1.11
Secondary

Mean Number of Medical Procedures Per Participant Per Month Before the First Stroke From 6 to 12 Months

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Medical Procedures Per Participant Per Month Before the First Stroke From 6 to 12 Months0.5 Procedures per participant per monthStandard Deviation 0.63
Participants Unexposed to OACsMean Number of Medical Procedures Per Participant Per Month Before the First Stroke From 6 to 12 Months0.5 Procedures per participant per monthStandard Deviation 0.68
Secondary

Mean Number of Outpatient Medical Procedures

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Outpatient Medical Procedures0.6 Medical proceduresStandard Deviation 0.93
Participants Unexposed to OACsMean Number of Outpatient Medical Procedures0.5 Medical proceduresStandard Deviation 0.86
Secondary

Mean Number of Outpatient Medical Procedures Per Participant Per Month of HCRU After the First Stroke From 6 to 12 Months

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Outpatient Medical Procedures Per Participant Per Month of HCRU After the First Stroke From 6 to 12 Months0.5 Procedures per participant per monthStandard Deviation 0.7
Participants Unexposed to OACsMean Number of Outpatient Medical Procedures Per Participant Per Month of HCRU After the First Stroke From 6 to 12 Months0.4 Procedures per participant per monthStandard Deviation 0.73
Secondary

Mean Number of Outpatient Visits Per Participant Per Month After the First Stroke From 6 to 12 Months

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Outpatient Visits Per Participant Per Month After the First Stroke From 6 to 12 MonthsPhysicians visits (private practice and home)1.0 Visits per participant per monthStandard Deviation 1.01
Participants Exposed to OACsMean Number of Outpatient Visits Per Participant Per Month After the First Stroke From 6 to 12 MonthsParamedic visits in community setting35.3 Visits per participant per monthStandard Deviation 44.24
Participants Exposed to OACsMean Number of Outpatient Visits Per Participant Per Month After the First Stroke From 6 to 12 MonthsPublic hospital outpatient visits (MSO and rehabilitation care facilities)0.2 Visits per participant per monthStandard Deviation 0.38
Participants Unexposed to OACsMean Number of Outpatient Visits Per Participant Per Month After the First Stroke From 6 to 12 MonthsPhysicians visits (private practice and home)0.9 Visits per participant per monthStandard Deviation 1.18
Participants Unexposed to OACsMean Number of Outpatient Visits Per Participant Per Month After the First Stroke From 6 to 12 MonthsParamedic visits in community setting29.4 Visits per participant per monthStandard Deviation 43.55
Participants Unexposed to OACsMean Number of Outpatient Visits Per Participant Per Month After the First Stroke From 6 to 12 MonthsPublic hospital outpatient visits (MSO and rehabilitation care facilities)0.2 Visits per participant per monthStandard Deviation 0.4
Secondary

Mean Number of Outpatient Visits Per Participant Per Month Before the First Stroke From 6 to 12 Months

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Outpatient Visits Per Participant Per Month Before the First Stroke From 6 to 12 MonthsPhysicians visits (private practice and home)1.1 Visits per participant per monthStandard Deviation 0.86
Participants Exposed to OACsMean Number of Outpatient Visits Per Participant Per Month Before the First Stroke From 6 to 12 MonthsParamedic visits in community setting29.7 Visits per participant per monthStandard Deviation 38.63
Participants Exposed to OACsMean Number of Outpatient Visits Per Participant Per Month Before the First Stroke From 6 to 12 MonthsPublic hospital outpatient visits (MSO and rehabilitation care facilities)0.2 Visits per participant per monthStandard Deviation 0.39
Participants Unexposed to OACsMean Number of Outpatient Visits Per Participant Per Month Before the First Stroke From 6 to 12 MonthsPhysicians visits (private practice and home)1.0 Visits per participant per monthStandard Deviation 0.87
Participants Unexposed to OACsMean Number of Outpatient Visits Per Participant Per Month Before the First Stroke From 6 to 12 MonthsParamedic visits in community setting20.3 Visits per participant per monthStandard Deviation 30.11
Participants Unexposed to OACsMean Number of Outpatient Visits Per Participant Per Month Before the First Stroke From 6 to 12 MonthsPublic hospital outpatient visits (MSO and rehabilitation care facilities)0.1 Visits per participant per monthStandard Deviation 0.32
Secondary

Mean Number of Paramedic Visits in Community Setting

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Paramedic Visits in Community Setting28.8 Paramedic visitsStandard Deviation 36.21
Participants Unexposed to OACsMean Number of Paramedic Visits in Community Setting23.4 Paramedic visitsStandard Deviation 38.22
Secondary

Mean Number of Physician Visits

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Physician Visits1.0 Physician visitsStandard Deviation 1.08
Participants Unexposed to OACsMean Number of Physician Visits0.8 Physician visitsStandard Deviation 1.04
Secondary

Mean Number of Public Hospital Outpatient Visits

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Public Hospital Outpatient Visits0.2 Outpatient visitsStandard Deviation 0.44
Participants Unexposed to OACsMean Number of Public Hospital Outpatient Visits0.2 Outpatient visitsStandard Deviation 0.42
Secondary

Mean Number of Reimbursed Transports Per Participant Per Month Before the First Stroke From 6 to 12 Months

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Reimbursed Transports Per Participant Per Month Before the First Stroke From 6 to 12 Months0.4 Transport per participant per monthStandard Deviation 0.99
Participants Unexposed to OACsMean Number of Reimbursed Transports Per Participant Per Month Before the First Stroke From 6 to 12 Months0.3 Transport per participant per monthStandard Deviation 0.92
Secondary

Mean Number of Reimbursed Transports Per Participant Per Month of HCRU After the First Stroke From 6 to 12 Months

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Reimbursed Transports Per Participant Per Month of HCRU After the First Stroke From 6 to 12 Months0.5 Transport per participant per monthStandard Deviation 1.2
Participants Unexposed to OACsMean Number of Reimbursed Transports Per Participant Per Month of HCRU After the First Stroke From 6 to 12 Months0.6 Transport per participant per monthStandard Deviation 1.48
Secondary

Mean Number of Travels Per Month

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Participants Exposed to OACsMean Number of Travels Per Month0.3 Travels per monthStandard Deviation 1.06
Participants Unexposed to OACsMean Number of Travels Per Month0.4 Travels per monthStandard Deviation 1.32
Secondary

Medical Procedures and Blood Examination Cost in Participants Exposed to and Unexposed to OAC

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Participants Exposed to OACsMedical Procedures and Blood Examination Cost in Participants Exposed to and Unexposed to OACOutpatient medical procedures (public and private settings)33.1 Euros per participant per monthStandard Deviation 101.54
Participants Exposed to OACsMedical Procedures and Blood Examination Cost in Participants Exposed to and Unexposed to OACBlood examination14.3 Euros per participant per monthStandard Deviation 24.54
Participants Unexposed to OACsMedical Procedures and Blood Examination Cost in Participants Exposed to and Unexposed to OACOutpatient medical procedures (public and private settings)28.2 Euros per participant per monthStandard Deviation 162.6
Participants Unexposed to OACsMedical Procedures and Blood Examination Cost in Participants Exposed to and Unexposed to OACBlood examination11.2 Euros per participant per monthStandard Deviation 31.92
Secondary

Number of Participants According to Number of Treatment Sequence

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.

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants Exposed to OACsNumber of Participants According to Number of Treatment SequenceOnly one sequence of treatment451539 Participants
Participants Exposed to OACsNumber of Participants According to Number of Treatment SequenceAt least two sequences of treatment120751 Participants
Secondary

Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC

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.

Time frame: 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.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Participants Exposed to OACsNumber of Participants According to Speciality of Prescriber for Participant Exposed to OACAt least one sequence of treatmentHospital-based physician222102 Participants
Participants Exposed to OACsNumber of Participants According to Speciality of Prescriber for Participant Exposed to OACAt least one sequence of treatmentGeneralist practitioners100629 Participants
Participants Exposed to OACsNumber of Participants According to Speciality of Prescriber for Participant Exposed to OACAt least one sequence of treatmentCity cardiologist134893 Participants
Participants Exposed to OACsNumber of Participants According to Speciality of Prescriber for Participant Exposed to OACAt least one sequence of treatmentOther114252 Participants
Participants Exposed to OACsNumber of Participants According to Speciality of Prescriber for Participant Exposed to OACAt least one sequence of treatmentNot specified414 Participants
Participants Exposed to OACsNumber of Participants According to Speciality of Prescriber for Participant Exposed to OACAt least two sequences of treatmentHospital-based physician27905 Participants
Participants Exposed to OACsNumber of Participants According to Speciality of Prescriber for Participant Exposed to OACAt least two sequences of treatmentGeneralist practitioners49635 Participants
Participants Exposed to OACsNumber of Participants According to Speciality of Prescriber for Participant Exposed to OACAt least two sequences of treatmentCity cardiologist19714 Participants
Participants Exposed to OACsNumber of Participants According to Speciality of Prescriber for Participant Exposed to OACAt least two sequences of treatmentOther23300 Participants
Participants Exposed to OACsNumber of Participants According to Speciality of Prescriber for Participant Exposed to OACAt least two sequences of treatmentNot specified197 Participants
Secondary

Number of Participants Classified According to Type of OAC Delivery for 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.

Time frame: 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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Participants Exposed to OACsNumber of Participants Classified According to Type of OAC Delivery for Participants Exposed to OACsApixaban245094 Participants
Participants Exposed to OACsNumber of Participants Classified According to Type of OAC Delivery for Participants Exposed to OACsRivaroxaban151288 Participants
Participants Exposed to OACsNumber of Participants Classified According to Type of OAC Delivery for Participants Exposed to OACsVKA56632 Participants
Participants Exposed to OACsNumber of Participants Classified According to Type of OAC Delivery for Participants Exposed to OACsDabigatran32632 Participants
Secondary

Number of Participants Who Were New Users of OAC and VKA

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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants Exposed to OACsNumber of Participants Who Were New Users of OAC and VKA421313 Participants
Participants Unexposed to OACsNumber of Participants Who Were New Users of OAC and VKA0 Participants
Secondary

Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC

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.

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants Exposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACSystemic azole antifungals3104 Participants
Participants Exposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACAntihypertensives354602 Participants
Participants Exposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACProtease inhibitors109 Participants
Participants Exposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACNSAIDs69466 Participants
Participants Exposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACOther CYP P450 3A4 inhibitors190900 Participants
Participants Exposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACMedical procedure of cardioversion6317 Participants
Participants Exposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACBeta-blockers330710 Participants
Participants Exposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACAntiarrhythmics204717 Participants
Participants Exposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACOral corticoids73061 Participants
Participants Exposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACGlucose-lowering drugs91864 Participants
Participants Exposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACAntiplatelet drugs206611 Participants
Participants Exposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACLipid-lowering drugs195863 Participants
Participants Exposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACProton pump inhibitors215924 Participants
Participants Exposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACDigitalis glycosides20783 Participants
Participants Exposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACNitrate derivatives23082 Participants
Participants Exposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACSSRIs37035 Participants
Participants Exposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACBenzodiazepines127625 Participants
Participants Exposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACOther anticoagulants30265 Participants
Participants Unexposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACBenzodiazepines97568 Participants
Participants Unexposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACBeta-blockers124236 Participants
Participants Unexposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACAntihypertensives198727 Participants
Participants Unexposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACAntiplatelet drugs150062 Participants
Participants Unexposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACOther anticoagulants32487 Participants
Participants Unexposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACNSAIDs40497 Participants
Participants Unexposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACOral corticoids52102 Participants
Participants Unexposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACProton pump inhibitors143103 Participants
Participants Unexposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACSSRIs32378 Participants
Participants Unexposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACSystemic azole antifungals3948 Participants
Participants Unexposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACProtease inhibitors97 Participants
Participants Unexposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACMedical procedure of cardioversion2603 Participants
Participants Unexposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACAntiarrhythmics61093 Participants
Participants Unexposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACGlucose-lowering drugs54691 Participants
Participants Unexposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACLipid-lowering drugs104804 Participants
Participants Unexposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACDigitalis glycosides5392 Participants
Participants Unexposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACNitrate derivatives17315 Participants
Participants Unexposed to OACsNumber of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OACOther CYP P450 3A4 inhibitors55864 Participants
Secondary

Number of Participants With Temporary or Permanent Treatment Discontinuation of OAC

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.

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants Exposed to OACsNumber of Participants With Temporary or Permanent Treatment Discontinuation of OACAt least one sequence of treatment167099 Participants
Participants Exposed to OACsNumber of Participants With Temporary or Permanent Treatment Discontinuation of OACAt least two sequences of treatment40849 Participants
Secondary

Number of Participants With Treatment Switch of OAC Treatment

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.

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants Exposed to OACsNumber of Participants With Treatment Switch of OAC TreatmentAt least one sequence of treatment48101 Participants
Participants Exposed to OACsNumber of Participants With Treatment Switch of OAC TreatmentAt least two sequences of treatment8592 Participants
Other Pre-specified

Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants

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.

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Participants Exposed to OACsNumber of Participants According to Subgroups in OAC Exposed and Unexposed ParticipantsFrail103521 Participants
Participants Exposed to OACsNumber of Participants According to Subgroups in OAC Exposed and Unexposed ParticipantsElderly (>=80 years)199562 Participants
Participants Exposed to OACsNumber of Participants According to Subgroups in OAC Exposed and Unexposed ParticipantsActive cancer75261 Participants
Participants Exposed to OACsNumber of Participants According to Subgroups in OAC Exposed and Unexposed ParticipantsPrevious stroke48610 Participants
Participants Exposed to OACsNumber of Participants According to Subgroups in OAC Exposed and Unexposed ParticipantsCoronary artery disease86531 Participants
Participants Exposed to OACsNumber of Participants According to Subgroups in OAC Exposed and Unexposed ParticipantsHigh CHA2DS2-VASc402191 Participants
Participants Exposed to OACsNumber of Participants According to Subgroups in OAC Exposed and Unexposed ParticipantsNon-elderly (18 to <80 years)286084 Participants
Participants Unexposed to OACsNumber of Participants According to Subgroups in OAC Exposed and Unexposed ParticipantsHigh CHA2DS2-VASc281168 Participants
Participants Unexposed to OACsNumber of Participants According to Subgroups in OAC Exposed and Unexposed ParticipantsElderly (>=80 years)170170 Participants
Participants Unexposed to OACsNumber of Participants According to Subgroups in OAC Exposed and Unexposed ParticipantsNon-elderly (18 to <80 years)162066 Participants
Participants Unexposed to OACsNumber of Participants According to Subgroups in OAC Exposed and Unexposed ParticipantsCoronary artery disease75022 Participants
Participants Unexposed to OACsNumber of Participants According to Subgroups in OAC Exposed and Unexposed ParticipantsFrail120900 Participants
Participants Unexposed to OACsNumber of Participants According to Subgroups in OAC Exposed and Unexposed ParticipantsPrevious stroke32268 Participants
Participants Unexposed to OACsNumber of Participants According to Subgroups in OAC Exposed and Unexposed ParticipantsActive cancer86281 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026