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

Bayer

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Drug: dabigatran (Pradaxa)

Drug: Vitamin K antagonists

Study type

Observational

Funder types

Industry

Identifiers

NCT02864758

18656

Details and patient eligibility

About

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

Full description

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.

Enrollment

99,999 patients

Sex

All

Ages

2 to 99 years old

Volunteers

No Healthy Volunteers

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