Percutaneous WATCHMAN Left Atrial Appendage Closure for Japanese Patients With Nonvalvular Atrial Fibrillation at Increased Risk of Thromboembolism - First Results From the SALUTE Trial -
Percutaneous WATCHMAN Left Atrial Appendage Closure for Japanese Patients With Nonvalvular Atrial Fibrillation at Increased Risk of Thromboembolism - First Results From the SALUTE Trial -
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DOI：
10.1253/circj.cj-18-0222
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发表时间：
2018-12-01
影响因子：
3.3
通讯作者：
Saito, Shigeru
中科院分区：
文献类型：
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作者：
Aonuma, Kazutaka;Yamasaki, Hiro;Saito, Shigeru
背景：PROTECT AF 和 PREVAIL 试验表明，WATCHMAN 左心耳 (LAA) 封堵器是美国和欧洲非瓣膜性心房颤动 (NVAF) 患者中风预防的华法林治疗的合理替代方案。我们在日本进行了 SALUTE 试验，以确认左心耳封堵治疗对 NVAF 患者的安全性和有效性。 方法和结果：共有 54 名 CHA2DS2-VASc 评分≥ 2 的 NVAF 受试者（包括 12 名 Roll-in）入组。所有受试者均成功植入左心耳封堵器。没有发生与主要手术安全终点相关的严重不良事件。第二个共同主要终点是所有卒中、全身性栓塞和心血管/不明原因死亡的复合终点。 6 个月随访期间发生 1 例缺血性中风（1/42）。定义为第三个共同主要终点的有效左心耳封堵率在 45 天和 6 个月的随访中均为 100%（42/42）。 结论：SALUTE 试验的手术安全性和 6 个月结果表明，左心耳封堵装置安全有效，与大规模随机临床试验的结果相似，为需要长期替代的日本 NVAF 患者提供了左心耳封堵的新视角。口服抗凝药。
Background: The PROTECT AF and PREVAIL trials demonstrated that the WATCHMAN left atrial appendage (LAA) closure device is a reasonable alternative to warfarin therapy for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) in the USA and Europe. We conducted the SALUTE trial to confirm the safety and efficacy of the LAA closure therapy for patients with NVAF in Japan.Methods and Results: A total of 54 subjects (including 12 Roll-in) with NVAF who had a CHA2DS2-VASc score >= 2 were enrolled. All subjects were successfully implanted with the LAA closure device. No serious adverse events related to the primary proceduresafety endpoint occurred. The 2nd co-primary endpoint was a composite of all stroke, systemic embolism and cardiovascular/unexplained death. One ischemic stroke (1/42) occurred during the 6-month follow-up. The effective LAA closure rate defined as the 3rd co-primary endpoint was 100% (42/42) at both 45-day and 6-month follow-up.Conclusions: The procedural safety and 6-month results from the SALUTE trial demonstrated that the LAA closure device was safe and effective, similar to the results of large-scale randomized clinical trials, and provides a novel perspective of LAA closure for Japanese patients with NVAF in need of an alternative to long-term oral-anticoagulation.