Antithrombotic therapy for atrial fibrillation with stable coronary disease

the AFIRE Investigators

研究成果: ジャーナルへの寄稿記事

5 引用 (Scopus)

抄録

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.

元の言語英語
ページ(範囲)1103-1113
ページ数11
ジャーナルNew England Journal of Medicine
381
発行部数12
DOI
出版物ステータス出版済み - 9 19 2019

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Atrial Fibrillation
Coronary Disease
Coronary Artery Disease
Therapeutics
Confidence Intervals
Safety
Platelet Aggregation Inhibitors
Unstable Angina
Percutaneous Coronary Intervention
Patient Safety
Group Psychotherapy
Embolism
Hemostasis
Coronary Artery Bypass
Anticoagulants
Cause of Death
Japan
Thrombosis
Stroke
Myocardial Infarction

All Science Journal Classification (ASJC) codes

  • Medicine(all)

これを引用

Antithrombotic therapy for atrial fibrillation with stable coronary disease. / the AFIRE Investigators.

:: New England Journal of Medicine, 巻 381, 番号 12, 19.09.2019, p. 1103-1113.

研究成果: ジャーナルへの寄稿記事

the AFIRE Investigators. / Antithrombotic therapy for atrial fibrillation with stable coronary disease. :: New England Journal of Medicine. 2019 ; 巻 381, 番号 12. pp. 1103-1113.
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title = "Antithrombotic therapy for atrial fibrillation with stable coronary disease",
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.",
author = "{the AFIRE Investigators} and Satoshi Yasuda and Koichi Kaikita and Masaharu Akao and Junya Ako and Tetsuya Matoba and Masato Nakamura and Katsumi Miyauchi and Nobuhisa Hagiwara and Kazuo Kimura and Atsushi Hirayama and Kunihiko Matsui and Hisao Ogawa",
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T1 - Antithrombotic therapy for atrial fibrillation with stable coronary disease

AU - the AFIRE Investigators

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

PY - 2019/9/19

Y1 - 2019/9/19

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.

AB - 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.

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