Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      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
    

Detailed 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.
    

Intervention name(s): Rivaroxaban (Xarelto, BAY59-7939); Vitamin K antagonists; dabigatran (Pradaxa)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, 20mg once daily; Tablets, dose is based on International Normalized Ratio; Tablets, 150 mg twice daily
Intervention MeSH terms: Vitamin K; Rivaroxaban; Dabigatran
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All subjects with a first reimbursed dispensation of rivaroxaban (15 or 20 mg), dabigatran
        (110 or 150 mg) or vitamin k antagonists in 2013 or 2014 diagnosed with Atrial Fibrillation