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心房颤动合并稳定型冠心病的抗血栓治疗
Antithrombotic Therapy for Atrial Fibrillation with Stable Coronary Disease


Satoshi Yasuda ... 心脑血管疾病 • 2019.09.19
相关阅读
• 时机问题:根据心房颤动患者ACS或PCI后的时间分层的抗血栓策略 • 接受PCI的心房颤动患者的出血预防研究

冠脉介入治疗合并房颤患者的抗血栓治疗

 

娄亚柯,刘巍*

首都医科大学附属北京安贞医院心内科

*通讯作者

 

研究背景

经皮冠状动脉介入治疗(PCI)后使用双联抗血小板治疗(P2Y12抑制剂+阿司匹林)可降低缺血性或动脉粥样硬化血栓事件的风险,包括支架内血栓形成、复发性心肌梗死及心血管原因死亡。在接受PCI治疗的冠心病患者中,5%~7%的患者有长期口服抗凝治疗的适应证。丹麦最近的一项全国队列研究表明,抗血小板药物联合抗凝治疗会增加出血事件的风险1。因此,为房颤合并稳定性冠心病患者选择最有效的抗血栓治疗是一个临床挑战,需要仔细评估每个患者的缺血和出血风险。

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摘要


背景

关于心房颤动合并稳定型冠心病患者的抗血栓治疗,来自随机试验的数据有限。

 

方法

在日本进行的一项多中心开放标签试验中,我们将2,236例心房颤动患者随机分组,分别接受利伐沙班(非维生素K拮抗剂类的口服抗凝剂)单药治疗或利伐沙班与一种抗血小板药联合治疗;这些患者已于超过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),或者血管造影证实冠心病但不需要血运重建。主要疗效终点是由卒中、全身性栓塞、心肌梗死、需要血运重建的不稳定型心绞痛或全因死亡构成的复合终点;我们以1.46的非劣效性界值对该终点进行了非劣效性分析。主要安全性终点是根据国际血栓与止血学会(International Society on Thrombosis and Hemostasis)标准定义的大出血;我们对该终点进行了优效性分析。

 

结果

由于联合治疗组的死亡率增加,因此本试验提前终止。在主要疗效终点方面,利伐沙班单药治疗不劣于联合治疗,每患者-年的事件发生率分别为4.14%和5.75%(风险比,0.72;95%置信区间[CI],0.55~0.95;非劣效性P<0.001)。在主要安全性终点方面,利伐沙班单药治疗优于联合治疗,每患者-年的事件发生率分别为1.62%和2.76%(风险比,0.59;95% CI,0.39~0.89;优效性P=0.01)。

 

结论

在心房颤动合并稳定型冠心病患者中,作为抗血栓治疗的利伐沙班单药治疗在疗效方面不劣于联合治疗,在安全性方面优于联合治疗(由日本心血管研究基金会[Japan Cardiovascular Research Foundation]资助;AFIRE在UMIN Clinical Trials Registry注册号为UMIN000016612;在ClinicalTrials.gov注册号为NCT02642419)。





作者信息

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*
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. Address reprint requests to Dr. Yasuda at the Japan Cardiovascular Research Foundation, National Cerebral and Cardiovascular Center, 6-1 Kishibe-Shimmachi, Suita, Osaka 565-8565, Japan, or at yasuda.satoshi.hp@ncvc.go.jp. *A full list of the AFIRE investigators and committee members is provided in the Supplementary Appendix, available at NEJM.org.

 

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