APIXABAN in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France SNIIRAM Study

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT02640222

Collaborator

(none)

321,501

Enrollment

Location

Actual Duration (Months)

4468.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the APIXABAN use in the Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation in Real-Life Setting in France, data from SNIIRAM (French data base).

Condition or Disease	Intervention/Treatment	Phase
Anticoagulation	Drug: VKA Drug: Apixaban Drug: dabigatran Drug: rivaroxaban

Study Design

Study Type:

Observational

Actual Enrollment :

321501 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

APIXABAN in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France SNIIRAM Study

Actual Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Dec 31, 2016

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
AC-naive treated with VKA AC-naive treated with VKA	Drug: VKA Other Names: Vitamin K antagonist
AC-naive treated with apixaban AC-naive treated with apixaban	Drug: Apixaban
AC-naive treated with dabigatran AC-naive treated with dabigatran	Drug: dabigatran
AC-naive treated with rivaroxaban AC-naive treated with rivaroxaban	Drug: rivaroxaban
AC-experienced treated with VKA AC-experienced treated with VKA	Drug: VKA Other Names: Vitamin K antagonist
AC-experienced treated with apixaban AC-experienced treated with apixaban	Drug: Apixaban
AC-experienced treated with dabigatran AC-experienced treated with dabigatran	Drug: dabigatran
AC-experienced treated with rivaroxaban AC-experienced treated with rivaroxaban	Drug: rivaroxaban

Outcome Measures

Primary Outcome Measures

Incidence rate of first event of stroke and/or systemic embolism over the period of AC exposure [Approximately 2 years]
Estimation by AC treatment and for both populations (AC-naive and AC-experienced patients) of Incidence rate (95%CI) of first event of stroke and/or systemic embolism (effectiveness) and of first event of major bleeding (safety) over the period of AC ex
Time-to-first occurrence of stroke or systemic embolism will be estimated and plotted using Kaplan-Meier product limit estimator [Approximately 2 years]
Estimation by AC treatment and for both populations (AC-naive and AC-experienced patients) of Time-to-first occurrence of stroke and/or systemic embolism (effectiveness) and of major bleedings (safety) using Kaplan-Meier product limit estimator (95%CI)

Secondary Outcome Measures

Incidence rates for composite morbidity criterion and all-cause death over the period of AC exposure will be estimated by AC treatment [Approximately 2 years]
Risk of occurrence of a composite morbidity criterion: number of patients presenting at least 1 event during the exposure period, incidence rate, median time to occurrence of event in each subcohort, composite morbidity criterion being defined by stroke, systemic embolism or major bleeding, whichever occurs first. Risk of all-cause mortality: number of deaths during exposure period to studied AC treatment, incidence rate, median survival time
Time-to-event for composite morbidity criterion and all-cause death using Kaplan-Meier product limit estimator (95%CI) [Approximately 2 years]
Major characteristics of patients will be described by AC treatments [Approximately 2 years]
Major characteristics of patients and comorbidities were: proportion of AC-naive patients by AC treatment In each subcohort: Sociodemographic characteristics: median age, sex ratio, region of residence, CMU-C (Universal Health Coverage Complementary) beneficiary, NVAF characteristics : time since NVAF diagnosis, ALD status distribution (ALD Type, ICD-10 code for diagnosis), Past hospital stay : number and total length of hospital stays Previous exposure to AC treatment (class, molecule) over the 3 previous years, for AC-experienced patients. Thromboembolism risk factors: CHADS2 mean score, CHA2DS2 VASc mean score, and distribution according to the scores. Bleeding risk factors: modified HASBLED mean score and distribution according to the scores Charlson mean score and distribution according to the scores
Treatment patterns at AC initiation, over time and concomitant treatment will be tabulated by AC treatment [Approximately 2 years]
Treatment patterns at AC initiation: Type of the prescriber initiating the AC treatment (general practitioners, office-based cardiologists, hospital-based physicians and others), prescribed dosages, duration of initial prescription, co prescription (others AC, antiplatelet agents, NSAIDs, SRIs, strong inhibitors of both CYP3A4, anticonvulsivant strong inducer of hepatic enzymes, rifampicine, antiarrhythmic drugs)
Time-to-discontinuation will be estimated and plotted using Kaplan-Meier product limit estimator [Approximately 2 years]
Time-to-discontinuation will be estimated and plotted using Kaplan-Meier product limit estimator based on Adherence to treatment: mean Medication Possession Ratio (MPR), Persistence: number for AC treatment discontinuation, median time to discontinuation
The healthcare resources utilization will be described by AC treatment [Approximately 2 years]
The healthcare resources utilization will be described by AC treatment based on number of medical visits, number of nurse acts, per category of act, number of drugs packages per therapeutic classes, number of biology and tests, per type of act, number of other explorations, number of hospital stays, number of sick leaves
Comparisons of major characteristics of patients between apixaban and each of the other AC treatments [Approximately 2 years]
Comparisons of major characteristics of patients between apixaban and each of the other AC treatments will be performed using: An analysis adjusted for confounding factors in order to verify adjustment quality and using: the Wald test from a logistic regression model for binary and other qualitative variables the F- test from a covariance analysis for quantitative variables An analysis after matching for confounding factors in order to verify matching quality and using: the Cochran-Mantel-Haenzel test for qualitative variables the F-test from a covariance analysis for quantitative variables
Comparison of incidence rates of each studied event (stroke or systemic thromboembolic event, major bleeding, all-cause death) between apixaban and each of the other usual AC treatments [Approximately 2 years]
Comparative time-to-event analyses for each studied event between apixaban and each of the other usual AC treatments [Approximately 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient meeting inclusion criteria of the French Système national d'information inter-régimes de l'assurance maladie (SNIIR-AM)/Programme de médicalisation des systèmes d'information (PMSI) claim databases (Patient insured by the French national health insurance general scheme stricto sensu (apart from local mutualist sections)
Patients with at least one reimbursement of AC treatment (acenocoumarol, warfarine and fluidione for VKA treatments, apixaban, dabigatran or rivaroxaban for New oral anticoagulants (NOACs)) treatments during the inclusion period
Patients initiated with a new AC treatment during the inclusion period, either AC naive or not
Patients aged 18 or older at their first anticoagulant initiation during the inclusion period
Patient diagnosed with non-valvular Atrial fibrillation (AF)