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穿皮左心房尾关闭 vs 华法林治疗心房动:一项随机临床试验

Vivek Y Reddy¹, Horst Sievert², Jonathan Halperin³

¹Mount Sinai School of Medicine, New York City, New York2St John's Health Center, Santa Monica, California3Homolka Hospital, Prague, Czech Republic.

|November 17, 2014

概括

发现机械左心房附属体 (LAA) 关闭在预防心房动 (AF) 患者中风和死亡方面不低于华法林,并且优于华法林. 这种LAA关闭策略在降低心血管和全因死亡率方面也表现出优越性.

科学领域:

心脏病学心脏病学
医疗器械医疗器械
临床试验临床试验

背景情况:

华法林在心房 (AF) 中有效预防中风,但有局限性,包括狭窄的治疗指数和药物/饮食相互作用.
机械左心房附属体 (LAA) 关闭为AF患者降低中风风险提供了替代策略.

研究的目的:

为了比较LAA关闭与华法林在非膜AF和至少一个中风风险因素的患者中的疗效和安全性.
为了确定LAA关闭是否在预防中风,全身血栓塞和心血管/不明原因死亡的复合终点方面与华法林不劣.

主要方法:

一项多中心,随机 (2:1),无盲目的贝叶斯设计的研究 (PROTECT AF) 涉及707名非膜性AF患者.
患者被分配到LAA关闭 (n=463) 或华法林 (n=244) 中,目标INR为2-3.
随访进行了4年,分析了综合疗效终点,包括中风,全身血栓塞和心血管/不明原因死亡.

主要成果:

在LAA关闭组中,每100个患者年发生的初级事件率为2.3事件,而在华法林组中每100个患者年发生的事件率为3.8事件 (发生率比,0.60).
与华法林相比,LAA的关闭符合非劣势 (后部概率>99.9%) 和优势 (后部概率96.0%) 的标准.
设备组的心血管死亡率 (3.7%vs9.0%) 和所有原因死亡率 (12.3%vs18.0%) 显著降低.

结论:

在高风险的AF患者中,皮肤穿透的LAA关闭在预防中风,全身血栓塞和心血管死亡方面不低于和优于华法林.
关闭LAA还在平均后续3.8年内,在降低心血管和全因死亡率方面表现出优越性.

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