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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.