Background:Percutaneous closure of the left atrial appendage (LAA) is an alternative to chronic oral anticoagulation to reduce stroke risk in patients with nonvalvular atrial fibrillation. The Amulet IDE trial (Amplatzer Amulet Left Atrial Appendage Occluder IDE Trial) was designed to evaluate the safety and effectiveness of the dual-seal mechanism of the Amulet LAA occluder compared with the Watchman device.Methods:Patients with nonvalvular atrial fibrillation at increased risk of stroke were randomly assigned (1:1) to undergo percutaneous implantation of a LAA occluder with the Amulet occluder or Watchman device. The primary end points included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic embolism at 18 months), and the rate of LAA occlusion at 45 days. Prespecified secondary end points included a composite of all stroke, systemic embolism, or cardiovascular/unexplained death at 18 months, major bleeding at 18 months, and superiority test of the 3 primary end points.Results:A total of 1878 patients were enrolled. The Amulet occluder was noninferior to the Watchman device for the primary safety end point (14.5% versus 14.7%; difference=–0.14 [95% CI, –3.42 to 3.13]; P<0.001 for noninferiority). Major bleeding and all-cause death were similar between groups (10.6% versus 10.0% and 3.9% versus 5.1%, respectively). Procedure-related complications were higher for the Amulet occluder (4.5% versus 2.5%), largely related to more frequent pericardial effusion and device embolization. The Amulet occluder was noninferior to the Watchman device for the primary effectiveness end point (2.8% versus 2.8%; difference=0.00 [95% CI, –1.55 to 1.55]; P<0.001 for noninferiority), and the composite of stroke, systemic embolism, or cardiovascular/unexplained death (5.6% versus 7.7%, difference=–2.12 [95% CI, –4.45 to 0.21]; P<0.001 for noninferiority). The rate of major bleeding was similar between groups (11.6% versus 12.3%; difference=–0.71 [95% CI, –3.72 to 2.31]; P=0.32 for superiority). LAA occlusion was higher for the Amulet occluder than for the Watchman device (98.9% versus 96.8%; difference=2.03 [95% CI, 0.41–3.66]; P<0.001 for noninferiority; P=0.003 for superiority).Conclusions:The Amulet occluder was noninferior for safety and effectiveness of stroke prevention for nonvalvular atrial fibrillation compared with the Watchman device and superior for LAA occlusion. Procedure-related complications were higher with the Amulet occluder and decreased with operator experience.Registration:URL: https://www.clinicaltrials.gov; Unique identifier: NCT02879448.

中文翻译：

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Amplatzer Amulet 左心耳封堵器与用于中风预防的 Watchman 装置 (Amulet IDE)：一项随机对照试验

背景：经皮左心耳封堵术 (LAA) 是慢性口服抗凝剂的替代方法，可降低非瓣膜性心房颤动患者的卒中风险。Amulet IDE 试验（Amplatzer Amulet Left Atrial Appendage Occluder IDE Trial）旨在评估 Amulet LAA 封堵器的双重密封机制与 Watchman 装置相比的安全性和有效性。方法：非瓣膜性心房颤动患者的风险增加中风患者被随机分配 (1:1) 接受 Amulet 封堵器或 Watchman 装置经皮植入 LAA 封堵器。主要终点包括安全性（12 个月时手术相关并发症、全因死亡或大出血的综合）、有效性（18 个月时缺血性卒中或全身性栓塞的综合）、和左心耳闭塞率在 45 天。预设的次要终点包括 18 个月时的所有卒中、全身性栓塞或心血管/不明原因死亡、18 个月时的大出血以及 3 个主要终点的优效性检验的复合终点。结果：共纳入 1878 名患者。Amulet 封堵器在主要安全终点方面不劣于 Watchman 装置（14.5% 对 14.7%；差异 =–0.14 [95% CI，–3.42 至 3.13]；7%；差异 =–0.14 [95% CI，–3.42 至 3.13]；7%；差异 =–0.14 [95% CI，–3.42 至 3.13]；对于非劣效性， P <0.001）。组间大出血和全因死亡相似（分别为 10.6% 对 10.0% 和 3.9% 对 5.1%）。Amulet 封堵器的手术相关并发症较高（4.5% 对 2.5%），主要与更频繁的心包积液和装置栓塞有关。Amulet 封堵器在主要有效性终点方面不劣于 Watchman 装置（2.8% 对 2.8%；差异 = 0.00 [95% CI，–1.55 至 1.55]；非劣效性P <0.001），以及卒中、全身栓塞或心血管/不明原因死亡（5.6% 对 7.7%，差异 =–2.12 [95% CI，–4.45 至 0.21]；P<0.001 表示非劣效性）。组间的大出血率相似（11.6% 对 12.3%；差异 =–0.71 [95% CI，–3.72 至 2.31]；P = 0.32 表示优效性）。Amulet 封堵器的 LAA 封堵率高于 Watchman 装置（98.9% 对 96.8%；差异 = 2.03 [95% CI，0.41-3.66]；P <0.001 表示非劣效性；P = 0.003 表示优越性）。结论：Amulet与 Watchman 装置相比，封堵器在预防非瓣膜性心房颤动中风​​的安全性和有效性方面不劣，在左心耳封堵方面更优越。Amulet 封堵器与手术相关的并发症较高，而随着操作者经验的增加而减少。注册：URL：https://www.clinicaltrials.gov；唯一标识符：NCT02879448。