Atrial Fibrillation
Conditions
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
AF Patient who were not exposed to oral anticoagulation
AF patients who received VKA
AF patients who received apixaban
AF patients who received rivaroxaban
AF patients who received dabigatran
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | 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 | 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. |
| Incidence Rate (Per 1000 Participant-years) of Stroke in Non-valvular Atrial Fibrillation (AF) Participants Exposed to Oral Anticoagulation (OAC) and Unexposed to OAC | 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 | 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 (Per 1000 Participant-years) of Major Bleeding in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 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 | 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 (Per 1000 Participant-years) of Death in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 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 | 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. |
| Number of Participants With Contraindications to OAC at Index Date in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 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 | 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. |
| Number of Participants Who Received Complimentary Universal Health Care (CMU-c) in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 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 | 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. |
| 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 | 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 | 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. |
| Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 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 | 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. |
| Number of Participants Classified as Per Modified CHA2DS2-VASc Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 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 | 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 Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 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 | 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. |
| Number of Participants Classified as Per Type of Stroke in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 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 | 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. |
| Number of Participants With Risk of Falls in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 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 | 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. |
| Number of Participants Who Were Polymedicated in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 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 | 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. |
| Number of Participants With Atleast One Visit to Nursing Home in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 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 | 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. |
| Age Adjusted Charlson Comorbidity Index (CCI) in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Reimbursed Transports Per Participant Per Month Before the First Stroke From 6 to 12 Months | 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 | 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 Before the First Stroke From 6 to 12 Months | 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 | 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 Before the First Stroke From 6 to 12 Months | 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 | 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 After the First Stroke From 6 to 12 Months | 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 | 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. |
| Mean Number of Outpatient Visits Per Participant Per Month After the First Stroke From 6 to 12 Months | 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 | 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 After the First Stroke From 6 to 12 Months | 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 | 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 of HCRU After the First Stroke From 6 to 12 Months | 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 | 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 of HCRU After the First Stroke From 6 to 12 Months | 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 | 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 After the First Stroke From 6 to 12 Months | 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 | 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 After the First Stroke From 6 to 12 Months | 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 | 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 in Participants Exposed to and Unexposed to OAC | 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 | 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 in Participants Exposed to and Unexposed to OAC | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 Laboratory Tests | 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 | 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 | 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 | 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 | 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 | 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. |
| Mean Number of Paramedic Visits in Community Setting | 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 | 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. |
| Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | 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 | 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 Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC | Anytime in 2016, 2017, 2018 and 2019; retrospective data was retrieved and analyzed during approximately 9 months of this observational 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 (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC | Anytime in 2016, 2017, 2018 and 2019; retrospective data was retrieved and analyzed during approximately 9 months of this observational 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. |
| Number of Participants Who Were New Users of OAC and VKA | 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 | 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 | 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 | 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 | 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 | 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. |
| Number of Participants With Treatment Switch of OAC Treatment | 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 | 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. |
| Number of Participants With Temporary or Permanent Treatment Discontinuation of OAC | 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 | 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. |
| Number of Participants Classified According to Type of OAC Delivery for Participants Exposed to OACs | 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 | 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. |
| Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC | 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 | 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 Per Participant Per Month Before the First Stroke From 6 to 12 Months | 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 | 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. |
| Mean Number of Outpatient Visits Per Participant Per Month Before the First Stroke From 6 to 12 Months | 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 | 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 (PPPM) Before the First Stroke From 6 to 12 Months | 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 | 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 Before the First Stroke From 6 to 12 Months | 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants | 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 | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 1,390,293 |
Baseline characteristics
| Characteristic | Participants Exposed to OACs | Participants Unexposed to OACs | Total |
|---|---|---|---|
| Age, Customized 80-90 years | 321396 Participants | 149231 Participants | 470627 Participants |
| Age, Customized <80 years | 528010 Participants | 212865 Participants | 740875 Participants |
| Age, Customized >=90 years | 94242 Participants | 84549 Participants | 178791 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 415404 Participants | 219829 Participants | 635233 Participants |
| Sex: Female, Male Male | 528244 Participants | 226816 Participants | 755060 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Age Adjusted Charlson Comorbidity Index (CCI) in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 2.32 Units on a scale | Standard Deviation 2.06 |
| Participants Unexposed to OACs | Age Adjusted Charlson Comorbidity Index (CCI) in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 3.6 Units on a scale | Standard Deviation 3.51 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | HAS-BLED Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 2.26 Units on a scale | Standard Deviation 0.99 |
| Participants Unexposed to OACs | HAS-BLED Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 2.5 Units on a scale | Standard Deviation 1.1 |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Exposed to OACs | Incidence Rate (Per 1000 Participant-years) of Death in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 41.1 Events per 1000 person years |
| Participants Unexposed to OACs | Incidence Rate (Per 1000 Participant-years) of Death in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 184.6 Events per 1000 person years |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Exposed to OACs | Incidence Rate (Per 1000 Participant-years) of Major Bleeding in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 21.5 Events per 1000 person years |
| Participants Unexposed to OACs | Incidence Rate (Per 1000 Participant-years) of Major Bleeding in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 23.6 Events per 1000 person years |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Exposed to OACs | Incidence Rate (Per 1000 Participant-years) of Stroke in Non-valvular Atrial Fibrillation (AF) Participants Exposed to Oral Anticoagulation (OAC) and Unexposed to OAC | 14.7 Events per 1000 person years |
| Participants Unexposed to OACs | Incidence Rate (Per 1000 Participant-years) of Stroke in Non-valvular Atrial Fibrillation (AF) Participants Exposed to Oral Anticoagulation (OAC) and Unexposed to OAC | 31.2 Events per 1000 person years |
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Exposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Pays de la Loire | 25684 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Unknown | 11562 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Provence-Alpes-Côte d Azur | 42929 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Auvergne-Rhône-Alpes | 56168 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Bretagne | 25892 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Centre-Val de Loire | 19626 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Corse | 2689 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Overseas districts and territories | 281 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Grand-Est | 43950 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Hauts-de-France | 44740 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Ile de France | 62389 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Normandie | 26059 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Nouvelle Aquitaine | 51529 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Occitanie | 47963 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Bourgogne-Franche-Comté | 24185 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Ile de France | 45815 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Provence-Alpes-Côte d Azur | 28422 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Overseas districts and territories | 135 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Pays de la Loire | 16155 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Nouvelle Aquitaine | 33123 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Unknown | 21098 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Grand-Est | 30014 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Auvergne-Rhône-Alpes | 34422 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Bourgogne-Franche-Comté | 13849 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Normandie | 16507 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Bretagne | 15574 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Hauts-de-France | 30567 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Centre-Val de Loire | 14146 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Occitanie | 30580 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Area of Residence in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Corse | 1829 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Anemia | 14756 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Vascular and neurodegenerative dementia | 23398 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Chronic obstructive pulmonary disease | 2654 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Other vascular diseases | 7843 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Diabetes | 99628 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Coronary arterial diseases | 86531 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Diabetes with complication | 1165 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Sleep disorders | 18149 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Connective tissue disease | 8376 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Myocardial infarction | 12063 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Ulcer disease | 2691 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Active cancer | 75261 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Cerebrovascular disease | 48715 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Mild liver disease | 7183 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Moderate-to-severe renal disease | 29846 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Malnutrition | 34650 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Congestive heart failure | 87559 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Moderate-to-severe liver disease | 1551 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Morbid obesity | 41052 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Hemiplegia | 4761 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Peripheral arterial disease | 24219 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Hemiplegia | 8159 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Coronary arterial diseases | 75022 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Vascular and neurodegenerative dementia | 46852 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Myocardial infarction | 8689 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Peripheral arterial disease | 30313 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Other vascular diseases | 10216 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Sleep disorders | 16376 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Active cancer | 86281 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Malnutrition | 78027 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Morbid obesity | 34823 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Anemia | 30332 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Chronic obstructive pulmonary disease | 3942 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Diabetes | 67412 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Diabetes with complication | 1322 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Connective tissue disease | 6960 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Ulcer disease | 6211 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Cerebrovascular disease | 58186 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Moderate-to-severe renal disease | 42083 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Mild liver disease | 10801 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Moderate-to-severe liver disease | 4234 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Comorbidities in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Congestive heart failure | 75117 Participants |
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Exposed to OACs | Number of Participants Classified as Per Modified CHA2DS2-VASc Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | High | 402191 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Modified CHA2DS2-VASc Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Moderate | 57481 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Modified CHA2DS2-VASc Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Low | 25974 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Modified CHA2DS2-VASc Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | High | 281168 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Modified CHA2DS2-VASc Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Moderate | 30413 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Modified CHA2DS2-VASc Score in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Low | 20655 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Exposed to OACs | Number of Participants Classified as Per Type of Stroke in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Both Ischemic and haemorrhagic | 1285 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Type of Stroke in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Hemorrhagic | 1025 Participants |
| Participants Exposed to OACs | Number of Participants Classified as Per Type of Stroke in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Ischemic | 36313 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Type of Stroke in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Both Ischemic and haemorrhagic | 5614 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Type of Stroke in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Hemorrhagic | 3996 Participants |
| Participants Unexposed to OACs | Number of Participants Classified as Per Type of Stroke in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | Ischemic | 38642 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Exposed to OACs | 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 | 10444 Participants |
| Participants Unexposed to OACs | Number of Participants Who Received Aid for Complementary Health Care (ACS) for Elderly Participants in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 8698 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Exposed to OACs | Number of Participants Who Received Complimentary Universal Health Care (CMU-c) in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 12819 Participants |
| Participants Unexposed to OACs | Number of Participants Who Received Complimentary Universal Health Care (CMU-c) in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 10198 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Exposed to OACs | Number of Participants Who Were Polymedicated in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 408403 Participants |
| Participants Unexposed to OACs | Number of Participants Who Were Polymedicated in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 291508 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Exposed to OACs | Number of Participants With Atleast One Visit to Nursing Home in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 16170 Participants |
| Participants Unexposed to OACs | Number of Participants With Atleast One Visit to Nursing Home in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 31493 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Exposed to OACs | Number of Participants With Contraindications to OAC at Index Date in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 49478 Participants |
| Participants Unexposed to OACs | Number of Participants With Contraindications to OAC at Index Date in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 86646 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Exposed to OACs | Number of Participants With Risk of Falls in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 186288 Participants |
| Participants Unexposed to OACs | Number of Participants With Risk of Falls in Non-valvular AF Participants Exposed to OAC and Unexposed to OAC | 170465 Participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Exposed to OACs | Annual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC | 2016 | 4.31 New cases per 1000 persons |
| Participants Exposed to OACs | Annual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC | 2017 | 4.13 New cases per 1000 persons |
| Participants Exposed to OACs | Annual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC | 2018 | 3.86 New cases per 1000 persons |
| Participants Exposed to OACs | Annual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC | 2019 | 3.73 New cases per 1000 persons |
| Participants Unexposed to OACs | Annual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC | 2019 | 1.22 New cases per 1000 persons |
| Participants Unexposed to OACs | Annual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC | 2016 | 1.75 New cases per 1000 persons |
| Participants Unexposed to OACs | Annual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC | 2018 | 1.38 New cases per 1000 persons |
| Participants Unexposed to OACs | Annual Incidence Rate of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC | 2017 | 1.59 New cases per 1000 persons |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Exposed to OACs | Annual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC | 2016 | 1.50 Prevalent cases per 1000 years |
| Participants Exposed to OACs | Annual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC | 2017 | 1.76 Prevalent cases per 1000 years |
| Participants Exposed to OACs | Annual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC | 2018 | 1.97 Prevalent cases per 1000 years |
| Participants Exposed to OACs | Annual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC | 2019 | 2.13 Prevalent cases per 1000 years |
| Participants Unexposed to OACs | Annual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC | 2019 | 0.82 Prevalent cases per 1000 years |
| Participants Unexposed to OACs | Annual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC | 2016 | 0.53 Prevalent cases per 1000 years |
| Participants Unexposed to OACs | Annual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC | 2018 | 0.75 Prevalent cases per 1000 years |
| Participants Unexposed to OACs | Annual Prevalence (Prevalent Cases Per 1000 Years) of Non-valvular AF in Participants Exposed to OAC and Unexposed to OAC | 2017 | 0.65 Prevalent cases per 1000 years |
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Participants Exposed to OACs | Duration of Each Sequence of OAC Treatment | At least one sequence of treatment | 9.5 Months |
| Participants Exposed to OACs | Duration of Each Sequence of OAC Treatment | At least two sequences of treatment | 6.9 Months |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Hospitalization Cost in Participants Exposed to and Unexposed to OAC | 434.1 Euros per participant per month | Standard Deviation 1885.73 |
| Participants Unexposed to OACs | Hospitalization Cost in Participants Exposed to and Unexposed to OAC | 1318.5 Euros per participant per month | Standard Deviation 32665.57 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Drugs Dispensed Per Participant Per Month After the First Stroke From 6 to 12 Months | 11.9 Drugs dispensed PPPM | Standard Deviation 10.66 |
| Participants Unexposed to OACs | Mean Number of Drugs Dispensed Per Participant Per Month After the First Stroke From 6 to 12 Months | 9.2 Drugs dispensed PPPM | Standard Deviation 10.43 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Drugs Dispensed Per Participant Per Month Before the First Stroke From 6 to 12 Months | 11.6 Drugs dispensed PPPM | Standard Deviation 7.44 |
| Participants Unexposed to OACs | Mean Number of Drugs Dispensed Per Participant Per Month Before the First Stroke From 6 to 12 Months | 9.1 Drugs dispensed PPPM | Standard Deviation 7.72 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Emergency Visits Per Month | 0.0 Emergency visits per month | Standard Deviation 0.23 |
| Participants Unexposed to OACs | Mean Number of Emergency Visits Per Month | 0.0 Emergency visits per month | Standard Deviation 0.2 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Hospital Stays Per Month | MSO hospital stays with and without emergency visit (public and private settings) | 0.2 Hospital stays per month | Standard Deviation 1 |
| Participants Exposed to OACs | Mean Number of Hospital Stays Per Month | Hospital stays in rehabilitation care facilities | 0.0 Hospital stays per month | Standard Deviation 0.07 |
| Participants Exposed to OACs | Mean Number of Hospital Stays Per Month | MSO hospital stays with palliative care (public and private settings) | 0.0 Hospital stays per month | Standard Deviation 0.08 |
| Participants Exposed to OACs | Mean Number of Hospital Stays Per Month | MSO hospital stays starting with emergency visit (public and private settings) | 0.0 Hospital stays per month | Standard Deviation 0.27 |
| Participants Unexposed to OACs | Mean Number of Hospital Stays Per Month | MSO hospital stays with palliative care (public and private settings) | 0.0 Hospital stays per month | Standard Deviation 0.4 |
| Participants Unexposed to OACs | Mean Number of Hospital Stays Per Month | Hospital stays in rehabilitation care facilities | 0.0 Hospital stays per month | Standard Deviation 0.52 |
| Participants Unexposed to OACs | Mean Number of Hospital Stays Per Month | MSO hospital stays with and without emergency visit (public and private settings) | 0.4 Hospital stays per month | Standard Deviation 1.77 |
| Participants Unexposed to OACs | Mean Number of Hospital Stays Per Month | MSO hospital stays starting with emergency visit (public and private settings) | 0.1 Hospital stays per month | Standard Deviation 0.46 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Hospital Stays Per Participant Per Month After the First Stroke From 6 to 12 Months | 0.2 Hospital stays per participant per month | Standard Deviation 1.04 |
| Participants Unexposed to OACs | Mean Number of Hospital Stays Per Participant Per Month After the First Stroke From 6 to 12 Months | 0.3 Hospital stays per participant per month | Standard Deviation 1.64 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Hospital Stays Per Participant Per Month Before the First Stroke From 6 to 12 Months | 0.2 Hospital stays per participant per month | Standard Deviation 0.96 |
| Participants Unexposed to OACs | Mean Number of Hospital Stays Per Participant Per Month Before the First Stroke From 6 to 12 Months | 0.2 Hospital stays per participant per month | Standard Deviation 0.88 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Laboratory Tests | 0.8 Laboratory tests | Standard Deviation 1.31 |
| Participants Unexposed to OACs | Mean Number of Laboratory Tests | 0.5 Laboratory tests | Standard Deviation 1.15 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Laboratory Tests Per Participant Per Month After the First Stroke From 6 to 12 Months | 0.9 Laboratory tests PPPM | Standard Deviation 1.48 |
| Participants Unexposed to OACs | Mean Number of Laboratory Tests Per Participant Per Month After the First Stroke From 6 to 12 Months | 0.6 Laboratory tests PPPM | Standard Deviation 1.21 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Laboratory Tests Per Participant Per Month (PPPM) Before the First Stroke From 6 to 12 Months | 1.0 Laboratory tests PPPM | Standard Deviation 1.42 |
| Participants Unexposed to OACs | Mean Number of Laboratory Tests Per Participant Per Month (PPPM) Before the First Stroke From 6 to 12 Months | 0.5 Laboratory tests PPPM | Standard Deviation 0.85 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Medical Devices Dispensed Per Participant Per Month After the First Stroke From 6 to 12 Months | 1.0 Medical devices dispensed PPPM | Standard Deviation 1.88 |
| Participants Unexposed to OACs | Mean Number of Medical Devices Dispensed Per Participant Per Month After the First Stroke From 6 to 12 Months | 1.0 Medical devices dispensed PPPM | Standard Deviation 1.97 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Medical Devices Dispensed Per Participant Per Month Before the First Stroke From 6 to 12 Months | 0.8 Medical devices dispensed PPPM | Standard Deviation 1.29 |
| Participants Unexposed to OACs | Mean Number of Medical Devices Dispensed Per Participant Per Month Before the First Stroke From 6 to 12 Months | 0.6 Medical devices dispensed PPPM | Standard Deviation 1.11 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Medical Procedures Per Participant Per Month Before the First Stroke From 6 to 12 Months | 0.5 Procedures per participant per month | Standard Deviation 0.63 |
| Participants Unexposed to OACs | Mean Number of Medical Procedures Per Participant Per Month Before the First Stroke From 6 to 12 Months | 0.5 Procedures per participant per month | Standard Deviation 0.68 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Outpatient Medical Procedures | 0.6 Medical procedures | Standard Deviation 0.93 |
| Participants Unexposed to OACs | Mean Number of Outpatient Medical Procedures | 0.5 Medical procedures | Standard Deviation 0.86 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Outpatient Medical Procedures Per Participant Per Month of HCRU After the First Stroke From 6 to 12 Months | 0.5 Procedures per participant per month | Standard Deviation 0.7 |
| Participants Unexposed to OACs | Mean Number of Outpatient Medical Procedures Per Participant Per Month of HCRU After the First Stroke From 6 to 12 Months | 0.4 Procedures per participant per month | Standard Deviation 0.73 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Outpatient Visits Per Participant Per Month After the First Stroke From 6 to 12 Months | Physicians visits (private practice and home) | 1.0 Visits per participant per month | Standard Deviation 1.01 |
| Participants Exposed to OACs | Mean Number of Outpatient Visits Per Participant Per Month After the First Stroke From 6 to 12 Months | Paramedic visits in community setting | 35.3 Visits per participant per month | Standard Deviation 44.24 |
| Participants Exposed to OACs | Mean Number of Outpatient Visits Per Participant Per Month After the First Stroke From 6 to 12 Months | Public hospital outpatient visits (MSO and rehabilitation care facilities) | 0.2 Visits per participant per month | Standard Deviation 0.38 |
| Participants Unexposed to OACs | Mean Number of Outpatient Visits Per Participant Per Month After the First Stroke From 6 to 12 Months | Physicians visits (private practice and home) | 0.9 Visits per participant per month | Standard Deviation 1.18 |
| Participants Unexposed to OACs | Mean Number of Outpatient Visits Per Participant Per Month After the First Stroke From 6 to 12 Months | Paramedic visits in community setting | 29.4 Visits per participant per month | Standard Deviation 43.55 |
| Participants Unexposed to OACs | Mean Number of Outpatient Visits Per Participant Per Month After the First Stroke From 6 to 12 Months | Public hospital outpatient visits (MSO and rehabilitation care facilities) | 0.2 Visits per participant per month | Standard Deviation 0.4 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Outpatient Visits Per Participant Per Month Before the First Stroke From 6 to 12 Months | Physicians visits (private practice and home) | 1.1 Visits per participant per month | Standard Deviation 0.86 |
| Participants Exposed to OACs | Mean Number of Outpatient Visits Per Participant Per Month Before the First Stroke From 6 to 12 Months | Paramedic visits in community setting | 29.7 Visits per participant per month | Standard Deviation 38.63 |
| Participants Exposed to OACs | Mean Number of Outpatient Visits Per Participant Per Month Before the First Stroke From 6 to 12 Months | Public hospital outpatient visits (MSO and rehabilitation care facilities) | 0.2 Visits per participant per month | Standard Deviation 0.39 |
| Participants Unexposed to OACs | Mean Number of Outpatient Visits Per Participant Per Month Before the First Stroke From 6 to 12 Months | Physicians visits (private practice and home) | 1.0 Visits per participant per month | Standard Deviation 0.87 |
| Participants Unexposed to OACs | Mean Number of Outpatient Visits Per Participant Per Month Before the First Stroke From 6 to 12 Months | Paramedic visits in community setting | 20.3 Visits per participant per month | Standard Deviation 30.11 |
| Participants Unexposed to OACs | Mean Number of Outpatient Visits Per Participant Per Month Before the First Stroke From 6 to 12 Months | Public hospital outpatient visits (MSO and rehabilitation care facilities) | 0.1 Visits per participant per month | Standard Deviation 0.32 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Paramedic Visits in Community Setting | 28.8 Paramedic visits | Standard Deviation 36.21 |
| Participants Unexposed to OACs | Mean Number of Paramedic Visits in Community Setting | 23.4 Paramedic visits | Standard Deviation 38.22 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Physician Visits | 1.0 Physician visits | Standard Deviation 1.08 |
| Participants Unexposed to OACs | Mean Number of Physician Visits | 0.8 Physician visits | Standard Deviation 1.04 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Public Hospital Outpatient Visits | 0.2 Outpatient visits | Standard Deviation 0.44 |
| Participants Unexposed to OACs | Mean Number of Public Hospital Outpatient Visits | 0.2 Outpatient visits | Standard Deviation 0.42 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Reimbursed Transports Per Participant Per Month Before the First Stroke From 6 to 12 Months | 0.4 Transport per participant per month | Standard Deviation 0.99 |
| Participants Unexposed to OACs | Mean Number of Reimbursed Transports Per Participant Per Month Before the First Stroke From 6 to 12 Months | 0.3 Transport per participant per month | Standard Deviation 0.92 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Reimbursed Transports Per Participant Per Month of HCRU After the First Stroke From 6 to 12 Months | 0.5 Transport per participant per month | Standard Deviation 1.2 |
| Participants Unexposed to OACs | Mean Number of Reimbursed Transports Per Participant Per Month of HCRU After the First Stroke From 6 to 12 Months | 0.6 Transport per participant per month | Standard Deviation 1.48 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Exposed to OACs | Mean Number of Travels Per Month | 0.3 Travels per month | Standard Deviation 1.06 |
| Participants Unexposed to OACs | Mean Number of Travels Per Month | 0.4 Travels per month | Standard Deviation 1.32 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Exposed to OACs | Medical Procedures and Blood Examination Cost in Participants Exposed to and Unexposed to OAC | Outpatient medical procedures (public and private settings) | 33.1 Euros per participant per month | Standard Deviation 101.54 |
| Participants Exposed to OACs | Medical Procedures and Blood Examination Cost in Participants Exposed to and Unexposed to OAC | Blood examination | 14.3 Euros per participant per month | Standard Deviation 24.54 |
| Participants Unexposed to OACs | Medical Procedures and Blood Examination Cost in Participants Exposed to and Unexposed to OAC | Outpatient medical procedures (public and private settings) | 28.2 Euros per participant per month | Standard Deviation 162.6 |
| Participants Unexposed to OACs | Medical Procedures and Blood Examination Cost in Participants Exposed to and Unexposed to OAC | Blood examination | 11.2 Euros per participant per month | Standard Deviation 31.92 |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Exposed to OACs | Number of Participants According to Number of Treatment Sequence | Only one sequence of treatment | 451539 Participants |
| Participants Exposed to OACs | Number of Participants According to Number of Treatment Sequence | At least two sequences of treatment | 120751 Participants |
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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants Exposed to OACs | Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC | At least one sequence of treatment | Hospital-based physician | 222102 Participants |
| Participants Exposed to OACs | Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC | At least one sequence of treatment | Generalist practitioners | 100629 Participants |
| Participants Exposed to OACs | Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC | At least one sequence of treatment | City cardiologist | 134893 Participants |
| Participants Exposed to OACs | Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC | At least one sequence of treatment | Other | 114252 Participants |
| Participants Exposed to OACs | Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC | At least one sequence of treatment | Not specified | 414 Participants |
| Participants Exposed to OACs | Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC | At least two sequences of treatment | Hospital-based physician | 27905 Participants |
| Participants Exposed to OACs | Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC | At least two sequences of treatment | Generalist practitioners | 49635 Participants |
| Participants Exposed to OACs | Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC | At least two sequences of treatment | City cardiologist | 19714 Participants |
| Participants Exposed to OACs | Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC | At least two sequences of treatment | Other | 23300 Participants |
| Participants Exposed to OACs | Number of Participants According to Speciality of Prescriber for Participant Exposed to OAC | At least two sequences of treatment | Not specified | 197 Participants |
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Exposed to OACs | Number of Participants Classified According to Type of OAC Delivery for Participants Exposed to OACs | Apixaban | 245094 Participants |
| Participants Exposed to OACs | Number of Participants Classified According to Type of OAC Delivery for Participants Exposed to OACs | Rivaroxaban | 151288 Participants |
| Participants Exposed to OACs | Number of Participants Classified According to Type of OAC Delivery for Participants Exposed to OACs | VKA | 56632 Participants |
| Participants Exposed to OACs | Number of Participants Classified According to Type of OAC Delivery for Participants Exposed to OACs | Dabigatran | 32632 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Exposed to OACs | Number of Participants Who Were New Users of OAC and VKA | 421313 Participants |
| Participants Unexposed to OACs | Number of Participants Who Were New Users of OAC and VKA | 0 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Exposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Systemic azole antifungals | 3104 Participants |
| Participants Exposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Antihypertensives | 354602 Participants |
| Participants Exposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Protease inhibitors | 109 Participants |
| Participants Exposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | NSAIDs | 69466 Participants |
| Participants Exposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Other CYP P450 3A4 inhibitors | 190900 Participants |
| Participants Exposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Medical procedure of cardioversion | 6317 Participants |
| Participants Exposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Beta-blockers | 330710 Participants |
| Participants Exposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Antiarrhythmics | 204717 Participants |
| Participants Exposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Oral corticoids | 73061 Participants |
| Participants Exposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Glucose-lowering drugs | 91864 Participants |
| Participants Exposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Antiplatelet drugs | 206611 Participants |
| Participants Exposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Lipid-lowering drugs | 195863 Participants |
| Participants Exposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Proton pump inhibitors | 215924 Participants |
| Participants Exposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Digitalis glycosides | 20783 Participants |
| Participants Exposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Nitrate derivatives | 23082 Participants |
| Participants Exposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | SSRIs | 37035 Participants |
| Participants Exposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Benzodiazepines | 127625 Participants |
| Participants Exposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Other anticoagulants | 30265 Participants |
| Participants Unexposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Benzodiazepines | 97568 Participants |
| Participants Unexposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Beta-blockers | 124236 Participants |
| Participants Unexposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Antihypertensives | 198727 Participants |
| Participants Unexposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Antiplatelet drugs | 150062 Participants |
| Participants Unexposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Other anticoagulants | 32487 Participants |
| Participants Unexposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | NSAIDs | 40497 Participants |
| Participants Unexposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Oral corticoids | 52102 Participants |
| Participants Unexposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Proton pump inhibitors | 143103 Participants |
| Participants Unexposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | SSRIs | 32378 Participants |
| Participants Unexposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Systemic azole antifungals | 3948 Participants |
| Participants Unexposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Protease inhibitors | 97 Participants |
| Participants Unexposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Medical procedure of cardioversion | 2603 Participants |
| Participants Unexposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Antiarrhythmics | 61093 Participants |
| Participants Unexposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Glucose-lowering drugs | 54691 Participants |
| Participants Unexposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Lipid-lowering drugs | 104804 Participants |
| Participants Unexposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Digitalis glycosides | 5392 Participants |
| Participants Unexposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Nitrate derivatives | 17315 Participants |
| Participants Unexposed to OACs | Number of Participants With Concomitant Treatments in Non-valvular AF Participants Who Were Exposed to OAC and Unexposed to OAC | Other CYP P450 3A4 inhibitors | 55864 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Exposed to OACs | Number of Participants With Temporary or Permanent Treatment Discontinuation of OAC | At least one sequence of treatment | 167099 Participants |
| Participants Exposed to OACs | Number of Participants With Temporary or Permanent Treatment Discontinuation of OAC | At least two sequences of treatment | 40849 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Exposed to OACs | Number of Participants With Treatment Switch of OAC Treatment | At least one sequence of treatment | 48101 Participants |
| Participants Exposed to OACs | Number of Participants With Treatment Switch of OAC Treatment | At least two sequences of treatment | 8592 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Exposed to OACs | Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants | Frail | 103521 Participants |
| Participants Exposed to OACs | Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants | Elderly (>=80 years) | 199562 Participants |
| Participants Exposed to OACs | Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants | Active cancer | 75261 Participants |
| Participants Exposed to OACs | Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants | Previous stroke | 48610 Participants |
| Participants Exposed to OACs | Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants | Coronary artery disease | 86531 Participants |
| Participants Exposed to OACs | Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants | High CHA2DS2-VASc | 402191 Participants |
| Participants Exposed to OACs | Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants | Non-elderly (18 to <80 years) | 286084 Participants |
| Participants Unexposed to OACs | Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants | High CHA2DS2-VASc | 281168 Participants |
| Participants Unexposed to OACs | Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants | Elderly (>=80 years) | 170170 Participants |
| Participants Unexposed to OACs | Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants | Non-elderly (18 to <80 years) | 162066 Participants |
| Participants Unexposed to OACs | Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants | Coronary artery disease | 75022 Participants |
| Participants Unexposed to OACs | Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants | Frail | 120900 Participants |
| Participants Unexposed to OACs | Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants | Previous stroke | 32268 Participants |
| Participants Unexposed to OACs | Number of Participants According to Subgroups in OAC Exposed and Unexposed Participants | Active cancer | 86281 Participants |