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Rivaroxaban Monotherapy in Atrial Fibrillation and Stable Coronary Artery Disease Across Body Mass Index Categories: a post-hoc analysis of the AFIRE trial

A post-hoc analysis of the AFIRE trial showed that in Japanese patients with atrial fibrillation and stable coronary artery disease, single-agent rivaroxaban therapy was as effective as combination therapy with rivaroxaban and a single-agent antiplatelet agent, regardless of BMI, according to This was presented by Dr. Masanobu Ishii of Kumamoto University at the Moderated ePosters session of the ESC Congress 2022.

The AFIRE study, involving 294 centers in Japan, included patients with a CHADS2 score of ≥1, atrial fibrillation, and at least 1 year of previous revascularization, or patients with angiographic evidence of coronary artery disease but no need for revascularization. The study reported non-inferiority in the prevention of cardiovascular events and a significantly lower risk of severe bleeding compared with the combination of rivaroxaban and a single-agent antiplatelet agent.

As a post-hoc analysis of the AFIRE study, this study examined outcomes by classifying 2,054 patients with available BMI into four groups according to BMI: underweight (<18.5 Kg/m²) group (72 patients), standard weight (18.5≦-<25 kg/m²) group (1,158 patients), overweight (25≦-<30 kg/m²) group (680 patients) and obese (≧30 kg/m²) group (144 subjects), and outcomes were examined.

The overall mean age was 75.0 years, the proportion of men was 79%, and the median CHA2DS2-VASc score was 4. The mean age was higher in the group with higher BMI, and the proportion of patients with hypertension, diabetes, dyslipidemia, and history of MI increased (all p<0.001).

For efficacy endpoints (all-cause mortality, MI, unstable angina requiring revascularization, stroke, and systemic embolism), monotherapy was significantly superior to combination therapy in the standard weight group (HR 0.64 [95%CI 0.44-0.95]), with no significant differences in other BMI categories. For the safety endpoint (severe bleeding by ISTH criteria), monotherapy was significantly superior in the overweight group (HR 0.25 [95%CI 0.10-0.62]), with no significant differences in the other categories. There was no significant interaction between BMI categories for either the efficacy of monotherapy or the safety endpoints (p=0.83, p=0.07).

Dr. Ishii concluded, "Monotherapy with rivaroxaban was shown to have similar clinical efficacy across all BMI categories in patients with atrial fibrillation and stable coronary artery disease."

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