Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99999 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-08

Study Completion Date

2018-09-30

Brief Summary

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The purpose of the study is to compare the one-year and two-year risk of each of the following individual outcomes: Stroke and systemic embolism (SE), major bleeding and death between new users of anticoagulant for Stroke prevention in atrial fibrillation (SPAF) during drug exposure: rivaroxaban versus Vitamin K antagonists (VKA), and rivaroxaban versus dabigatran

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Detailed Description

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Main objective: To compare the one-year and two-year risk of each of the following individual outcomes: Stroke and systemic embolism (SE), major bleeding and death between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran.

Secondary objectives:

* To describe the drug exposure to rivaroxaban, dabigatran, and VKA for SPAF in new users, as well as and pattern of use;
* To compare the one-year and two-year risk of the following individual outcomes: a composite of stroke and SE, major bleeding and death, clinically relevant bleeding (CRB) and acute coronary syndrome (ACS) between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran;
* To estimate the cumulative incidence and the incidence rate of each individual main and secondary outcome (stroke and SE, major bleeding, CRB, death, composite criteria, and ACS), as well as according to individual diagnose of each of these outcomes, during drug exposure for rivaroxaban, dabigatran, and VKA;
* To estimate the cumulative incidence of each individual main and secondary outcome (stroke and SE, major bleeding, CRB, death, composite criteria, and ACS), as well as according individual diagnose of each of these outcomes during post-anticoagulant exposure for rivaroxaban, dabigatran, and VKA (i.e. after anticoagulant discontinuation);
* To assess outcome risk factors, including (but not limited to), gender, age, stroke and bleeding risk scores (CHA2DS2-VASc and HAS-BLED), low or high dosage at index date for DOAC, drug predisposing to bleeding during drug exposure and significant baseline characteristics;
* To describe and compare healthcare resources utilisation related to SPAF during rivaroxaban, dabigatran, and VKA exposure, including outcomes, and their related costs from the societal perspective and from the French healthcare insurance perspective.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

Adult patients with nonvalvular atrial fibrillation (NVAF) treated with rivaroxaban

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

Tablets, 20mg once daily

Group 2

Adult patients with nonvalvular atrial fibrillation (NVAF) treated with vitamin k anatognists

Vitamin K antagonists

Intervention Type DRUG

Tablets, dose is based on International Normalized Ratio

Group 3

Adult patients with nonvalvular atrial fibrillation (NVAF) treated with dabigatran

dabigatran (Pradaxa)

Intervention Type DRUG

Tablets, 150 mg twice daily

Interventions

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Rivaroxaban (Xarelto, BAY59-7939)

Tablets, 20mg once daily

Intervention Type DRUG

Vitamin K antagonists

Tablets, dose is based on International Normalized Ratio

Intervention Type DRUG

dabigatran (Pradaxa)

Tablets, 150 mg twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Definite non-valvular atrial fibrillation:
* A first reimbursed dispensation of rivaroxaban, dabigatran, or VKA in 2013 or 2014, and
* No previous DOAC (rivaroxaban, dabigatran, apixaban) or VKA dispensation during the previous three years,
* Definite AF information in the database Probable non-valvular atrial fibrillation:-
* A first reimbursed dispensation of rivaroxaban, dabigatran, or VKA in 2013 or 2014, and
* No previous DOAC (rivaroxaban, dabigatran, apixaban) or VKA dispensation during the previous three years,
* Probable AF information in the database (using the development of an AF disease score, see variables definition below),

Exclusion Criteria

* Patients with Rheumatic valve disease
* Patients with valve replacement
* Patients treated with anticoagulants for venous
* thromboemboslim or prevention of venous
* thromboembolism after orthopedic surgery

Minimum Eligible Age

2 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No