TY - JOUR
T1 - Antithrombotic therapy for atrial fibrillation and coronary artery disease in patients with prior atherothrombotic disease
T2 - A post hoc analysis of the afire trial
AU - AFIRE Investigators
AU - Matsuzawa, Yasushi
AU - Kimura, Kazuo
AU - Yasuda, Satoshi
AU - Kaikita, Koichi
AU - Akao, Masaharu
AU - Ako, Junya
AU - Matoba, Tetsuya
AU - Nakamura, Masato
AU - Miyauchi, Katsumi
AU - Hagiwara, Nobuhisa
AU - Hirayama, Atsushi
AU - Matsui, Kunihiko
AU - Ogawa, Hisao
N1 - Funding Information:
This work was supported by the Japan Cardiovascular Research Foundation based on a contract with Bayer Yakuhin, Ltd., which had no role in the design of the trial, collection or analysis of the data, interpretation of the trial results, or writing of the article.
Funding Information:
Dr Kimura reports grants from the Japan Cardiovascular Research Foundation; grants and personal fees from Bayer Yakuhin, Daiichi Sankyo, Sanofi, MSD, and AstraZeneca; personal fees from Bristol-Myers Squibb and Nippon Boehringer Ingelheim. Dr Yasuda reports grants from Takeda Pharmaceutical, Abbott, and Boston Scientific; personal fees from Daiichi-Sankyo and Bristol-Meyers. Dr Kaikita reports grants from Grants-in-Aid for Scientific Research (20K08451) from the Ministry of Education, Culture, Sports, Science and Technology of Japan; grants and personal fees from Bayer Yakuhin and Daiichi Sankyo. Dr Akao reports grants from the Japan Agency for Medical Research and Development; personal fees from Bristol-Myers Squibb and Nippon Boehringer Ingelheim; grants and personal fees from Bayer Yakuhin and Daiichi Sankyo. Dr Ako reports personal fees from Bayer Yakuhin and Sanofi; grants and personal fees from Daiichi Sankyo. Dr Matoba reports grants from Japan Cardiovascular Research Foundation; personal fees from Nippon Boehringer Ingelheim, Daiichi Sankyo, Astra Zeneca, and Bayer Yakuhin. Dr Nakmaura reports grants and personal fees from Bayer Yakuhin, Daiichi Sankyo, and Sanofi; personal fees from Bristol-Myers Squibb and Nippon Boehringer Ingelheim. Dr Miyauchi reports personal fees from Amgen Astellas BioPharma, Astellas Pharma, MSD, Bayer Yakuhin, Sanofi, Takeda Pharmaceutical, Daiichi-Sankyo, Nippon Boehringer Ingelheim, and Bristol-Myers Squibb. Dr Hagiwara reports grants and personal fees from Bayer Yakuhin; grants from Nippon Boehringer Ingelheim; personal fees from Bristol-Myers Squibb. Dr Hirayama reports grants and personal fees from Boston Scientific Japan, Otsuka Pharmaceutical, Sanofi, Astellas Pharma, Bristol-Myers Squibb, Daiichi Sankyo, and Bayer Yakuhin; grants from Fukuda Denshi, Abbott Japan, Japan Lifeline, Takeda Pharmaceutical, Sumitomo Dainippon Pharma; personal fees from Toa Eiyo, Nippon Boehringer Ingelheim, Amgen Astellas BioPharma, and AstraZeneca. Dr Ogawa reports personal fees from Towa Pharmaceutical, Bristol-Meyers Squibb, Pfizer, Toa Eiyo, Bayer Yakuhin, and Novartis Pharma. The remaining authors have no disclosures to report.
Publisher Copyright:
© 2021 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley. T.
PY - 2021
Y1 - 2021
N2 - BACKGROUND: Among patients with atrial fibrillation and stable coronary artery disease, those with histories of atherothrom-botic disease are at high-risk for future ischemic events. This study investigated the efficacy and safety of rivaroxaban mono-therapy in patients with atrial fibrillation, coronary artery disease, and histories of atherothrombotic disease. METHODS AND RESULTS: This was a post hoc subanalysis of the AFIRE (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) trial. Patients with non-valvular atrial fibrillation and coronary artery disease were recruited and randomized to receive the rivaroxaban monotherapy or combination therapy with rivaroxaban plus antiplatelet drug. For the purpose of this sub-study, participants were divided into 2 subgroups, including the atherothrom-bosis group (those with histories of myocardial infarction, stroke, and/or peripheral artery disease; n=1052, 47.5%) and non-atherothrombosis group (n=1163, 52.5%). The efficacy end point included cardiovascular events or all-cause death, while the safety end point was major bleeding. Net adverse events consisted of all-cause death, myocardial infarction, stroke, or major bleeding. In the atherothrombosis group, rivaroxaban monotherapy was significantly associated with a lower risk of net adverse events when compared with combination therapy (hazard ratio [HR], 0.50; 95% CI, 0.34– 0.74; P<0.001), with a decrease in both efficacy (HR, 0.68; 95% CI, 0.47– 0.99; P=0.044) and safety (HR, 0.37; 95% CI, 0.19– 0.71; P=0.003) end points. By contrast, there were no differences between treatment outcomes for the non-atherothrombosis group. CONCLUSIONS: Rivaroxaban monotherapy significantly reduced net adverse events as compared with combination therapy for patients with atrial fibrillation, coronary artery disease, and prior atherothrombotic disease. REGISTRATION: URL: https://www.umin.ac.jp/ctr/; Unique identifier: UMIN000016612. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02642419.
AB - BACKGROUND: Among patients with atrial fibrillation and stable coronary artery disease, those with histories of atherothrom-botic disease are at high-risk for future ischemic events. This study investigated the efficacy and safety of rivaroxaban mono-therapy in patients with atrial fibrillation, coronary artery disease, and histories of atherothrombotic disease. METHODS AND RESULTS: This was a post hoc subanalysis of the AFIRE (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) trial. Patients with non-valvular atrial fibrillation and coronary artery disease were recruited and randomized to receive the rivaroxaban monotherapy or combination therapy with rivaroxaban plus antiplatelet drug. For the purpose of this sub-study, participants were divided into 2 subgroups, including the atherothrom-bosis group (those with histories of myocardial infarction, stroke, and/or peripheral artery disease; n=1052, 47.5%) and non-atherothrombosis group (n=1163, 52.5%). The efficacy end point included cardiovascular events or all-cause death, while the safety end point was major bleeding. Net adverse events consisted of all-cause death, myocardial infarction, stroke, or major bleeding. In the atherothrombosis group, rivaroxaban monotherapy was significantly associated with a lower risk of net adverse events when compared with combination therapy (hazard ratio [HR], 0.50; 95% CI, 0.34– 0.74; P<0.001), with a decrease in both efficacy (HR, 0.68; 95% CI, 0.47– 0.99; P=0.044) and safety (HR, 0.37; 95% CI, 0.19– 0.71; P=0.003) end points. By contrast, there were no differences between treatment outcomes for the non-atherothrombosis group. CONCLUSIONS: Rivaroxaban monotherapy significantly reduced net adverse events as compared with combination therapy for patients with atrial fibrillation, coronary artery disease, and prior atherothrombotic disease. REGISTRATION: URL: https://www.umin.ac.jp/ctr/; Unique identifier: UMIN000016612. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02642419.
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U2 - 10.1161/JAHA.121.020907
DO - 10.1161/JAHA.121.020907
M3 - Article
C2 - 34658247
AN - SCOPUS:85120823688
VL - 10
JO - Journal of the American Heart Association
JF - Journal of the American Heart Association
SN - 2047-9980
IS - 21
M1 - e020907
ER -