日本心血管研究基金会的Satoshi Yasuda与合作者研究探讨了抗血栓药物治疗房颤和稳定型冠心病的疗效和安全性。相关论文9月2日在线发表于《新英格兰医学杂志》。

在日本进行的这项多中心、开放性试验中，研究组招募了2236名房颤患者，他们均在1年前接受了经皮冠状动脉介入治疗（PCI）或冠状动脉旁路移植术（CABG），或经血管造影证实患有冠状动脉疾病且无需行血运重建。随机分配只口服利伐沙班（一种非维生素K拮抗剂的口服抗凝剂）或利伐沙班+一种抗血小板药物（联合治疗组）。

由于联合治疗组的死亡率增加，试验提前终止。利伐沙班单药组中有4.14%的患者发生中风、全身性栓塞、心肌梗死、需要重新血运重建的不稳定心绞痛或全因死亡，显著低于联合治疗组（5.75%），风险比为0.72。利伐沙班单药组中有1.62%的患者发生大出血，显著低于联合治疗组（2.76%），风险比为0.59。

综上，利伐沙班单药抗血栓治疗房颤和稳定型冠心病的疗效和安全性均优于联合治疗。

附：英文原文

Title: Antithrombotic Therapy for Atrial Fibrillation with Stable Coronary Disease

Author: Satoshi Yasuda, M.D., Ph.D., Koichi Kaikita, M.D., Ph.D., Masaharu Akao, M.D., Ph.D., Junya Ako, M.D., Ph.D., Tetsuya Matoba, M.D., Ph.D., Masato Nakamura, M.D., Ph.D., Katsumi Miyauchi, M.D., Ph.D., Nobuhisa Hagiwara, M.D., Ph.D., Kazuo Kimura, M.D., Ph.D., Atsushi Hirayama, M.D., Ph.D., Kunihiko Matsui, M.D., M.P.H., and Hisao Ogawa, M.D., Ph.D. for the AFIRE Investigators*

Issue&Volume: September 2, 2019

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. opens in new tab; and ClinicalTrials.gov number, NCT02642419. opens in new tab.)