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

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).

Study Overview

• Status: Completed
• Conditions: Anticoagulation
• Intervention / Treatment: Drug: Apixaban; Drug: rivaroxaban; Drug: VKA; Drug: dabigatran

• Study Type: Observational
• Enrollment (Actual): 321501

Contacts and Locations

Study Locations

• France
  • Rueil-malmaison Cedex, France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

AC-naive and AC-experienced patients diagnosed with non-valvular AF, initiated with either apixaban, dabigatran, rivaroxaban or VKAs

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of first event of stroke and/or systemic embolism over the period of AC exposure	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	Approximately 2 years
Time-to-first occurrence of stroke or systemic embolism will be estimated and plotted using Kaplan-Meier product limit estimator	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)	Approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rates for composite morbidity criterion and all-cause death over the period of AC exposure will be estimated by AC treatment	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	Approximately 2 years
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	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 staysPrevious 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 scoresCharlson mean score and distribution according to the scores	Approximately 2 years
Treatment patterns at AC initiation, over time and concomitant treatment will be tabulated by AC treatment	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)	Approximately 2 years
Time-to-discontinuation will be estimated and plotted using Kaplan-Meier product limit estimator	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	Approximately 2 years
The healthcare resources utilization will be described by AC treatment	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	Approximately 2 years
Comparisons of major characteristics of patients between apixaban and each of the other AC treatments	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 variablesthe 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 variablesthe F-test from a covariance analysis for quantitative variables	Approximately 2 years
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ACTUAL): December 31, 2016
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: December 22, 2015
• First Submitted That Met QC Criteria: December 22, 2015
• First Posted (ESTIMATE): December 28, 2015

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Embolism; Atrial Fibrillation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrin Modulating Agents; Protease Inhibitors; Micronutrients; Vitamins; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Antifibrinolytic Agents; Hemostatics; Coagulants; Vitamin K; Rivaroxaban; Dabigatran; Apixaban
• Other Study ID Numbers: CV185-285