TY - JOUR
T1 - Rivaroxaban Monotherapy in Atrial Fibrillation and Stable Coronary Artery Disease Across Body Mass Index Categories
AU - AFIRE Investigators
AU - Ishii, Masanobu
AU - Kaikita, Koichi
AU - Yasuda, Satoshi
AU - Akao, Masaharu
AU - Ako, Junya
AU - Matoba, Tetsuya
AU - Nakamura, Masato
AU - Miyauchi, Katsumi
AU - Hagiwara, Nobuhisa
AU - Kimura, Kazuo
AU - Hirayama, Atsushi
AU - Matsui, Kunihiko
AU - Ogawa, Hisao
AU - Tsujita, Kenichi
N1 - Funding Information:
This work was supported by the Japan Cardiovascular Research Foundation based on a contract with Bayer Yakuhin, Ltd, which did not have a role in the design of the trial, collection or analysis of the data, interpretation of the trial results, or writing of the manuscript. Dr Kaikita has received remuneration for lectures from Bayer Yakuhin, Daiichi-Sankyo, Novartis Pharma, and Otsuka Pharmaceutical; has received trust research/joint research funds from Bayer Yakuhin and Daiichi-Sankyo; and has received scholarship funds from Abbott Medical. Dr Yasuda has received grants from Takeda Pharmaceutical, Abbott, and Boston Scientific; and personal fees from Daiichi-Sankyo and Bristol Myers Squibb. Dr Akao has received grants from the Japan Agency for Medical Research and Development; personal fees from Bristol Myers Squibb and Nippon Boehringer Ingelheim; and grants and personal fees from Bayer Yakuhin and Daiichi-Sankyo. Dr Ako has received personal fees from Bayer Yakuhin and Sanofi; and grants and personal fees from Daiichi-Sankyo. Dr Matoba has received grants from the Japan Cardiovascular Research Foundation; and personal fees from Nippon Boehringer Ingelheim, Daiichi-Sankyo, AstraZeneca, and Bayer Yakuhin. Dr Nakamura has received grants and personal fees from Bayer Yakuhin, Daiichi-Sankyo, and Sanofi; and personal fees from Bristol Myers Squibb and Nippon Boehringer Ingelheim. Dr Miyauchi has received personal fees from Amgen Astellas BioPharma, Astellas Pharma, Merck Sharp and Dohme, Bayer Yakuhin, Sanofi, Takeda Pharmaceutical, Daiichi-Sankyo, Nippon Boehringer Ingelheim, and Bristol Myers Squibb. Dr Hagiwara has received grants and personal fees from Bayer Yakuhin and Nippon Boehringer Ingelheim; and personal fees from Bristol Myers Squibb. Dr Kimura has received grants from the Japan Cardiovascular Research Foundation grants and personal fees from Bayer Yakuhin, Daiichi-Sankyo, Sanofi, Merck Sharp and Dohme, and AstraZeneca; and personal fees from Bristol Myers Squibb and Nippon Boehringer Ingelheim. Dr Hirayama has received grants and personal fees from Boston Scientific Japan, Otsuka Pharmaceutical, Sanofi, Astellas Pharma, Bristol Myers Squibb, Daiichi-Sankyo, Bayer Yakuhin, Fukuda Denshi, Abbott Japan, Japan Lifeline, Takeda Pharmaceutical, and Sumitomo Dainippon Pharma; and personal fees from Toa Eiyo, Nippon Boehringer Ingelheim, Amgen Astellas BioPharma, and AstraZeneca. Dr Ogawa has received personal fees from Towa Pharmaceutical, Bristol Meyers Squibb, Pfizer, Toa Eiyo, Bayer Yakuhin, and Novartis Pharma. Dr Tsujita has received significant research grants from AMI, Bayer Yakuhin, Bristol-Myers, EA Pharma, Mochida Pharmaceutical; scholarship funds from AMI, Bayer Yakuhin, Boehringer Ingelheim Japan, Chugai Pharmaceutical, Daiichi-Sankyo, Edwards Lifesciences Corporation, Johnson and Johnson, Ono Pharmaceutical, Otsuka Pharmaceutical, and Takeda Pharmaceutical; and honoraria from Amgen, Bayer Yakuhin, Daiichi-Sankyo, Kowa Pharmaceutical, Novartis Pharma, Otsuka Pharmaceutical, and Pfizer Japan; and belongs to the endowed departments donated by Abbott Japan, Boston Scientific Japan, Fides-one, GM Medical, ITI, Kaneka Medix, Nipro Corporation, Terumo, Abbott Medical, Cardinal Health Japan, Fukuda Denshi, Japan Lifeline, Medical Appliance, and Medtronic Japan. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2022 The Authors
PY - 2022
Y1 - 2022
N2 - 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 (Congestive Heart Failure, Hypertension, Age ≥ 65 or ≥ 75, Diabetes, Prior Cardioembolic Event, [female] Sex, or Vascular Disease) 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.
AB - 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 (Congestive Heart Failure, Hypertension, Age ≥ 65 or ≥ 75, Diabetes, Prior Cardioembolic Event, [female] Sex, or Vascular Disease) 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.
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U2 - 10.1016/j.jacasi.2022.08.004
DO - 10.1016/j.jacasi.2022.08.004
M3 - Article
AN - SCOPUS:85138191372
JO - JACC: Asia
JF - JACC: Asia
SN - 2772-3747
ER -
