Rivaroxaban Monotherapy in Atrial Fibrillation and Stable Coronary Artery Disease Across Body Mass Index Categories.

BACKGROUND: The AFIRE (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) trial showed both noninferiority for efficacy and superiority for safety endpoints of rivaroxaban monotherapy compared with those of rivaroxaban plus antiplatelet therapy (combination therapy) in patients with atrial fibrillation and stable coronary artery disease.

OBJECTIVES: This study sought to evaluate outcomes of rivaroxaban monotherapy in those patients across body mass index (BMI) categories.

METHODS: Patients were categorized into 4 groups: underweight (BMI <18.5 kg/m2 ), normal weight (BMI 18.5 to <25 kg/m2 ), overweight (BMI 25 to <30 kg/m2 ), and obesity (BMI ≥30 kg/m2 ). Efficacy (a composite of all-cause death, myocardial infarction, unstable angina requiring revascularization, stroke, or systemic embolism) and safety (major bleeding defined according to International Society on Thrombosis and Haemostasis criteria) were compared between rivaroxaban monotherapy and combination therapy across BMI categories.

RESULTS: This study analyzed 2,054 patients with a median age of 75.0 years and CHA2 DS2 -VASc score of 4. A significant interaction was not observed between BMI categories and effect of monotherapy for efficacy ( P =  0.83) and safety ( P = 0.07), although monotherapy was superior to combination therapy for efficacy in normal weight (HR: 0.64; 95% CI: 0.44-0.95) and safety in overweight (HR: 0.25; 95% CI: 0.10-0.62), whereas a significant difference in the endpoints was not observed in the other BMI categories.

CONCLUSIONS: Rivaroxaban monotherapy had a similar effect on prognosis across all BMI categories in patients with atrial fibrillation and stable coronary artery disease. (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease [AFIRE]; UMIN000016612, NCT02642419).