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Antithrombotic Therapy for Atrial Fibrillation with Stable Coronary Disease.
N Engl J Med 2019; 381(12):1103-1113NEJM

Abstract

BACKGROUND

There are limited data from randomized trials evaluating the use of antithrombotic therapy in patients with atrial fibrillation and stable coronary artery disease.

METHODS

In a multicenter, open-label trial conducted in Japan, we randomly assigned 2236 patients with atrial fibrillation who had undergone percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) more than 1 year earlier or who had angiographically confirmed coronary artery disease not requiring revascularization to receive monotherapy with rivaroxaban (a non-vitamin K antagonist oral anticoagulant) or combination therapy with rivaroxaban plus a single antiplatelet agent. The primary efficacy end point was a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death from any cause; this end point was analyzed for noninferiority with a noninferiority margin of 1.46. The primary safety end point was major bleeding, according to the criteria of the International Society on Thrombosis and Hemostasis; this end point was analyzed for superiority.

RESULTS

The trial was stopped early because of increased mortality in the combination-therapy group. Rivaroxaban monotherapy was noninferior to combination therapy for the primary efficacy end point, with event rates of 4.14% and 5.75% per patient-year, respectively (hazard ratio, 0.72; 95% confidence interval [CI], 0.55 to 0.95; P<0.001 for noninferiority). Rivaroxaban monotherapy was superior to combination therapy for the primary safety end point, with event rates of 1.62% and 2.76% per patient-year, respectively (hazard ratio, 0.59; 95% CI, 0.39 to 0.89; P = 0.01 for superiority).

CONCLUSIONS

As antithrombotic therapy, rivaroxaban monotherapy was noninferior to combination therapy for efficacy and superior for safety in patients with atrial fibrillation and stable coronary artery disease. (Funded by the Japan Cardiovascular Research Foundation; AFIRE UMIN Clinical Trials Registry number, UMIN000016612; and ClinicalTrials.gov number, NCT02642419.).

Authors+Show Affiliations

From the National Cerebral and Cardiovascular Center, Suita (S.Y., H.O.), the Department of Cardiology, Osaka Police Hospital, Osaka (A.H.), the Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University (K. Kaikita), and the Department of General Medicine, Kumamoto University Hospital (K. Matsui), Kumamoto, the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M.A.), the Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara (J.A.), the Department of Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (T.M.), the Division of Cardiovascular Medicine, Toho University Ohashi Medical Center (M.N.), the Department of Cardiology, Juntendo University School of Medicine (K. Miyauchi), and the Department of Cardiology, Tokyo Women's Medical University (N.H.), Tokyo, and the Cardiovascular Center, Yokohama City University Medical Center, Yokohama (K. Kimura) - all in Japan.From the National Cerebral and Cardiovascular Center, Suita (S.Y., H.O.), the Department of Cardiology, Osaka Police Hospital, Osaka (A.H.), the Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University (K. Kaikita), and the Department of General Medicine, Kumamoto University Hospital (K. Matsui), Kumamoto, the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M.A.), the Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara (J.A.), the Department of Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (T.M.), the Division of Cardiovascular Medicine, Toho University Ohashi Medical Center (M.N.), the Department of Cardiology, Juntendo University School of Medicine (K. Miyauchi), and the Department of Cardiology, Tokyo Women's Medical University (N.H.), Tokyo, and the Cardiovascular Center, Yokohama City University Medical Center, Yokohama (K. Kimura) - all in Japan.From the National Cerebral and Cardiovascular Center, Suita (S.Y., H.O.), the Department of Cardiology, Osaka Police Hospital, Osaka (A.H.), the Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University (K. Kaikita), and the Department of General Medicine, Kumamoto University Hospital (K. Matsui), Kumamoto, the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M.A.), the Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara (J.A.), the Department of Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (T.M.), the Division of Cardiovascular Medicine, Toho University Ohashi Medical Center (M.N.), the Department of Cardiology, Juntendo University School of Medicine (K. Miyauchi), and the Department of Cardiology, Tokyo Women's Medical University (N.H.), Tokyo, and the Cardiovascular Center, Yokohama City University Medical Center, Yokohama (K. Kimura) - all in Japan.From the National Cerebral and Cardiovascular Center, Suita (S.Y., H.O.), the Department of Cardiology, Osaka Police Hospital, Osaka (A.H.), the Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University (K. Kaikita), and the Department of General Medicine, Kumamoto University Hospital (K. Matsui), Kumamoto, the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M.A.), the Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara (J.A.), the Department of Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (T.M.), the Division of Cardiovascular Medicine, Toho University Ohashi Medical Center (M.N.), the Department of Cardiology, Juntendo University School of Medicine (K. Miyauchi), and the Department of Cardiology, Tokyo Women's Medical University (N.H.), Tokyo, and the Cardiovascular Center, Yokohama City University Medical Center, Yokohama (K. Kimura) - all in Japan.From the National Cerebral and Cardiovascular Center, Suita (S.Y., H.O.), the Department of Cardiology, Osaka Police Hospital, Osaka (A.H.), the Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University (K. Kaikita), and the Department of General Medicine, Kumamoto University Hospital (K. Matsui), Kumamoto, the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M.A.), the Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara (J.A.), the Department of Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (T.M.), the Division of Cardiovascular Medicine, Toho University Ohashi Medical Center (M.N.), the Department of Cardiology, Juntendo University School of Medicine (K. Miyauchi), and the Department of Cardiology, Tokyo Women's Medical University (N.H.), Tokyo, and the Cardiovascular Center, Yokohama City University Medical Center, Yokohama (K. Kimura) - all in Japan.From the National Cerebral and Cardiovascular Center, Suita (S.Y., H.O.), the Department of Cardiology, Osaka Police Hospital, Osaka (A.H.), the Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University (K. Kaikita), and the Department of General Medicine, Kumamoto University Hospital (K. Matsui), Kumamoto, the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M.A.), the Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara (J.A.), the Department of Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (T.M.), the Division of Cardiovascular Medicine, Toho University Ohashi Medical Center (M.N.), the Department of Cardiology, Juntendo University School of Medicine (K. Miyauchi), and the Department of Cardiology, Tokyo Women's Medical University (N.H.), Tokyo, and the Cardiovascular Center, Yokohama City University Medical Center, Yokohama (K. Kimura) - all in Japan.From the National Cerebral and Cardiovascular Center, Suita (S.Y., H.O.), the Department of Cardiology, Osaka Police Hospital, Osaka (A.H.), the Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University (K. Kaikita), and the Department of General Medicine, Kumamoto University Hospital (K. Matsui), Kumamoto, the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M.A.), the Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara (J.A.), the Department of Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (T.M.), the Division of Cardiovascular Medicine, Toho University Ohashi Medical Center (M.N.), the Department of Cardiology, Juntendo University School of Medicine (K. Miyauchi), and the Department of Cardiology, Tokyo Women's Medical University (N.H.), Tokyo, and the Cardiovascular Center, Yokohama City University Medical Center, Yokohama (K. Kimura) - all in Japan.From the National Cerebral and Cardiovascular Center, Suita (S.Y., H.O.), the Department of Cardiology, Osaka Police Hospital, Osaka (A.H.), the Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University (K. Kaikita), and the Department of General Medicine, Kumamoto University Hospital (K. Matsui), Kumamoto, the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M.A.), the Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara (J.A.), the Department of Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (T.M.), the Division of Cardiovascular Medicine, Toho University Ohashi Medical Center (M.N.), the Department of Cardiology, Juntendo University School of Medicine (K. Miyauchi), and the Department of Cardiology, Tokyo Women's Medical University (N.H.), Tokyo, and the Cardiovascular Center, Yokohama City University Medical Center, Yokohama (K. Kimura) - all in Japan.From the National Cerebral and Cardiovascular Center, Suita (S.Y., H.O.), the Department of Cardiology, Osaka Police Hospital, Osaka (A.H.), the Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University (K. Kaikita), and the Department of General Medicine, Kumamoto University Hospital (K. Matsui), Kumamoto, the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M.A.), the Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara (J.A.), the Department of Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (T.M.), the Division of Cardiovascular Medicine, Toho University Ohashi Medical Center (M.N.), the Department of Cardiology, Juntendo University School of Medicine (K. Miyauchi), and the Department of Cardiology, Tokyo Women's Medical University (N.H.), Tokyo, and the Cardiovascular Center, Yokohama City University Medical Center, Yokohama (K. Kimura) - all in Japan.From the National Cerebral and Cardiovascular Center, Suita (S.Y., H.O.), the Department of Cardiology, Osaka Police Hospital, Osaka (A.H.), the Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University (K. Kaikita), and the Department of General Medicine, Kumamoto University Hospital (K. Matsui), Kumamoto, the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M.A.), the Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara (J.A.), the Department of Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (T.M.), the Division of Cardiovascular Medicine, Toho University Ohashi Medical Center (M.N.), the Department of Cardiology, Juntendo University School of Medicine (K. Miyauchi), and the Department of Cardiology, Tokyo Women's Medical University (N.H.), Tokyo, and the Cardiovascular Center, Yokohama City University Medical Center, Yokohama (K. Kimura) - all in Japan.From the National Cerebral and Cardiovascular Center, Suita (S.Y., H.O.), the Department of Cardiology, Osaka Police Hospital, Osaka (A.H.), the Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University (K. Kaikita), and the Department of General Medicine, Kumamoto University Hospital (K. Matsui), Kumamoto, the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M.A.), the Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara (J.A.), the Department of Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (T.M.), the Division of Cardiovascular Medicine, Toho University Ohashi Medical Center (M.N.), the Department of Cardiology, Juntendo University School of Medicine (K. Miyauchi), and the Department of Cardiology, Tokyo Women's Medical University (N.H.), Tokyo, and the Cardiovascular Center, Yokohama City University Medical Center, Yokohama (K. Kimura) - all in Japan.From the National Cerebral and Cardiovascular Center, Suita (S.Y., H.O.), the Department of Cardiology, Osaka Police Hospital, Osaka (A.H.), the Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University (K. Kaikita), and the Department of General Medicine, Kumamoto University Hospital (K. Matsui), Kumamoto, the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M.A.), the Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara (J.A.), the Department of Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (T.M.), the Division of Cardiovascular Medicine, Toho University Ohashi Medical Center (M.N.), the Department of Cardiology, Juntendo University School of Medicine (K. Miyauchi), and the Department of Cardiology, Tokyo Women's Medical University (N.H.), Tokyo, and the Cardiovascular Center, Yokohama City University Medical Center, Yokohama (K. Kimura) - all in Japan.No affiliation info available

Pub Type(s)

Comparative Study
Equivalence Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31475793

Citation

Yasuda, Satoshi, et al. "Antithrombotic Therapy for Atrial Fibrillation With Stable Coronary Disease." The New England Journal of Medicine, vol. 381, no. 12, 2019, pp. 1103-1113.
Yasuda S, Kaikita K, Akao M, et al. Antithrombotic Therapy for Atrial Fibrillation with Stable Coronary Disease. N Engl J Med. 2019;381(12):1103-1113.
Yasuda, S., Kaikita, K., Akao, M., Ako, J., Matoba, T., Nakamura, M., ... Ogawa, H. (2019). Antithrombotic Therapy for Atrial Fibrillation with Stable Coronary Disease. The New England Journal of Medicine, 381(12), pp. 1103-1113. doi:10.1056/NEJMoa1904143.
Yasuda S, et al. Antithrombotic Therapy for Atrial Fibrillation With Stable Coronary Disease. N Engl J Med. 2019 09 19;381(12):1103-1113. PubMed PMID: 31475793.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Antithrombotic Therapy for Atrial Fibrillation with Stable Coronary Disease. 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 - Kimura,Kazuo, AU - Hirayama,Atsushi, AU - Matsui,Kunihiko, AU - Ogawa,Hisao, AU - ,, Y1 - 2019/09/02/ PY - 2019/9/3/pubmed PY - 2019/9/27/medline PY - 2019/9/3/entrez SP - 1103 EP - 1113 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 381 IS - 12 N2 - BACKGROUND: There are limited data from randomized trials evaluating the use of antithrombotic therapy in patients with atrial fibrillation and stable coronary artery disease. METHODS: In a multicenter, open-label trial conducted in Japan, we randomly assigned 2236 patients with atrial fibrillation who had undergone percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) more than 1 year earlier or who had angiographically confirmed coronary artery disease not requiring revascularization to receive monotherapy with rivaroxaban (a non-vitamin K antagonist oral anticoagulant) or combination therapy with rivaroxaban plus a single antiplatelet agent. The primary efficacy end point was a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death from any cause; this end point was analyzed for noninferiority with a noninferiority margin of 1.46. The primary safety end point was major bleeding, according to the criteria of the International Society on Thrombosis and Hemostasis; this end point was analyzed for superiority. RESULTS: The trial was stopped early because of increased mortality in the combination-therapy group. Rivaroxaban monotherapy was noninferior to combination therapy for the primary efficacy end point, with event rates of 4.14% and 5.75% per patient-year, respectively (hazard ratio, 0.72; 95% confidence interval [CI], 0.55 to 0.95; P<0.001 for noninferiority). Rivaroxaban monotherapy was superior to combination therapy for the primary safety end point, with event rates of 1.62% and 2.76% per patient-year, respectively (hazard ratio, 0.59; 95% CI, 0.39 to 0.89; P = 0.01 for superiority). CONCLUSIONS: As antithrombotic therapy, rivaroxaban monotherapy was noninferior to combination therapy for efficacy and superior for safety in patients with atrial fibrillation and stable coronary artery disease. (Funded by the Japan Cardiovascular Research Foundation; AFIRE UMIN Clinical Trials Registry number, UMIN000016612; and ClinicalTrials.gov number, NCT02642419.). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/31475793/Antithrombotic_Therapy_for_Atrial_Fibrillation_with_Stable_Coronary_Disease L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa1904143?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -