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
Study Type
OBSERVATIONAL
Enrollment
2,140,403
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
Pfizer Investigational Site
Paris, France
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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Time frame: Anytime in 2016, 2017, 2018 and 2019; retrospective data was retrieved and analyzed during approximately 9 months of this observational study
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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