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

Masanobu Ishii; Koichi Kaikita; Satoshi Yasuda; Masaharu Akao; Junya Ako; Tetsuya Matoba; Masato Nakamura; Katsumi Miyauchi; Nobuhisa Hagiwara; Kazuo Kimura; Atsushi Hirayama; Kunihiko Matsui; Hisao Ogawa; Kenichi Tsujita; AFIRE Investigators

doi:10.1016/j.jacasi.2022.08.004

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

JACC Asia. 2022 Aug 27;2(7):882-893. doi: 10.1016/j.jacasi.2022.08.004. eCollection 2022 Dec.

Authors

Affiliations

¹ Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Kumamoto, Japan.
² Division of Cardiovascular Medicine and Nephrology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Kiyotake, Miyazaki, Japan.
³ Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.
⁴ Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Kyoto, Japan.
⁵ Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
⁶ Department of Cardiovascular Medicine, Faculty of Medical Sciences, Kyushu University, Fukuoka, Fukuoka, Japan.
⁷ Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Meguro-ku, Tokyo, Japan.
⁸ Department of Cardiovascular Medicine, Juntendo Tokyo Koto Geriatric Medical Center, Koto-ku, Tokyo, Japan.
⁹ Department of Cardiology, Tokyo Women's Medical University, Shinjuku-ku, Tokyo, Japan.
¹⁰ Cardiovascular Center, Yokohama City University Medical Center, Yokohama, Kanagawa, Japan.
¹¹ Department of Cardiology, Osaka Police Hospital, Osaka, Osaka, Japan.
¹² Department of General Medicine and Primary Care, Kumamoto University Hospital, Kumamoto, Kumamoto, Japan.
¹³ Kumamoto University, Kumamoto, Kumamoto, Japan.

Abstract

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 CHA₂DS₂-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).

Keywords: AF, atrial fibrillation; BMI, body mass index; CAD, coronary artery disease; DOAC, direct oral anticoagulants; MACCE, major adverse cardiac and cerebral event(s); NACE, net adverse clinical event(s); atrial fibrillation; coronary artery disease; obese; underweight.

Associated data

ClinicalTrials.gov/NCT02642419