Atrial fibrillation and ischemic events with rivaroxaban in patients with stable coronary artery disease (AFIRE):...

Area of Science:

• Cardiology
• Pharmacology
• Clinical Trials

Background:

• Dual therapy with anticoagulants and antiplatelet drugs is common in atrial fibrillation (AF) and coronary artery disease (CAD) patients.
• Dual therapy increases bleeding risk, necessitating careful benefit-risk assessment.
• Limited evidence exists for anticoagulant monotherapy, especially direct oral anticoagulants, in stable CAD patients post-percutaneous coronary intervention (PCI).

Purpose of the Study:

• To evaluate the efficacy and safety of rivaroxaban monotherapy compared to dual therapy in non-valvular AF (NVAF) patients with stable CAD.
• To assess the primary composite endpoint of cardiovascular events and all-cause mortality.
• To determine the primary safety endpoint of major bleeding.

Main Methods:

• A multicenter, prospective, randomized, open-label study (AFIRE Study) in ~2200 NVAF and CAD patients.
• Patients enrolled at least 1 year post-PCI or without significant coronary lesions.
• Randomization to either rivaroxaban monotherapy or rivaroxaban plus an antiplatelet agent (aspirin, clopidogrel, or prasugrel).

Main Results:

• Primary efficacy endpoints include cardiovascular events (stroke, embolism, myocardial infarction, unstable angina) and all-cause mortality.
• Primary safety endpoint is major bleeding, defined by International Society on Thrombosis and Haemostasis criteria.
• Study results are pending.

Conclusions:

• This study is the first to assess the efficacy and safety of rivaroxaban monotherapy in NVAF patients with stable CAD.
• Findings will inform clinical practice regarding anticoagulant monotherapy in this patient group.
• The study addresses a critical gap in evidence for managing anticoagulation in CAD patients with AF.