NEJM:依度沙班对比维生素K拮抗剂治疗TAVR后房颤的疗效比较

2021-12-02 MedSci原创 MedSci原创

在成功接受TAVR的房颤患者中,依度沙班不劣于维生素K拮抗剂,根据不良临床事件复合主要结局的风险比界限为38%。依度沙班治疗的大出血发生率高于维生素K拮抗剂。

与维生素K拮抗剂相比,直接口服抗凝剂对成功经导管主动脉瓣置换术(TAVR)后房颤的作用尚未得到充分证实。

近日,顶级医学期刊NEJM上发表了一篇研究文章,研究人员进行了一项多中心、前瞻性、随机、开放标签、盲法的试验,比较了依度沙班与维生素K拮抗剂在成功TAVR后的患病或新发房颤患者作为口服抗凝治疗的指征。

该研究的主要疗效结局是复合不良事件,包括全因死亡、心肌梗死、缺血性卒中、全身性血栓栓塞、瓣膜血栓形成或大出血。该研究的主要安全性结局是大出血。在分层测试计划的基础上,依次评估了主要疗效和安全性结局的非劣效性,如果风险比的95%置信区间的上限不超过1.38,则确定依度沙班的非劣效性。如果确定了大出血的非劣效性和优效性,则进行依度沙班疗效优效性的评估。

该研究共招募了1426名患者(每组713名)。患者的平均年龄为82.1岁,47.5%的患者为女性。几乎所有患者在TAVR之前都有房颤。依度沙班组的复合主要疗效结局发生率为17.3/100人每年,维生素K拮抗剂组为16.5/100人每年(风险比为1.05;95%置信区间[CI]为0.85至1.31;对于非劣效性,P=0.01)。大出血率分别为9.7人/100人每年和7.0/100人每年(风险比为1.40;95%CI为1.03至1.91;非劣效性P=0.93);组间差异主要是由于依度沙班的胃肠道出血较多。依度沙班组中任何原因或卒中的死亡率为每100人每年10.0人,维生素K拮抗剂组为每100人每年11.7人(风险比为0.85;95%CI为0.66至1.11)。

由此可见,在成功接受TAVR的房颤患者中,依度沙班不劣于维生素K拮抗剂,根据不良临床事件复合主要结局的风险比界限为38%。依度沙班治疗的大出血发生率高于维生素K拮抗剂。

原始出处:
 
Nicolas M. Van Mieghem,et al.Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR.NEJM.2021.https://www.nejm.org/doi/full/10.1056/NEJMoa2111016

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