Kansas City Heart Rhythm Institute and Research Foundation, Overland Park, Kansas, USA.
Tufts Medical Center, Boston, Massachusetts, USA.
JACC Cardiovasc Interv. 2023 Aug 14;16(15):1902-1913. doi: 10.1016/j.jcin.2023.06.022.
The Amulet (Abbott) left atrial appendage occluder investigational device exemption trial is the largest randomized trial evaluating the safety and effectiveness of the Amulet left atrial appendage occluder compared with the Watchman 2.5 device (Boston Scientific) through 5 years.
This analysis evaluated the device effect on 3-year outcomes in the Amulet investigational device exemption trial.
The medication regimen and key clinical outcomes were reported through 3 years including: 1) the composite of ischemic stroke or systemic embolism (SE); 2) the composite of all strokes, SE, or cardiovascular (CV) death; 3) major bleeding; and 4) all-cause death and CV death.
A total of 1,878 patients at 108 sites were randomized. A significantly higher percentage of patients were free of oral anticoagulation usage at 3 years with Amulet (96.2%) vs Watchman (92.5%) (P < 0.01). Clinical outcomes were comparable for the composite of ischemic stroke or SE (5.0% vs 4.6%; P = 0.69); the composite of all strokes, SE, or CV death (11.1% vs 12.7%; P = 0.31); major bleeding (16.1% vs 14.7%; P = 0.46); all-cause death (14.6% vs 17.9%; P = 0.08); and CV death (6.6% vs 8.5%; P = 0.14) for Amulet and Watchman, respectively. Through 3 years, device factors (device-related thrombus or peridevice leak ≥3 mm) preceded ischemic stroke events and CV deaths more frequently in Watchman compared with Amulet patients.
The Amulet occluder demonstrated continued safety and effectiveness with over 96% free of oral anticoagulation usage through 3 years in a high-risk population compared to the Watchman device. (AMPLATZER Amulet LAA Occluder Trial [Amulet IDE]; NCT02879448).
Amulet（雅培）左心耳封堵器研究性器械豁免试验是迄今为止最大的一项随机试验，旨在评估与 Watchman 2.5 装置（波士顿科学公司）相比，Amulet 左心耳封堵器的安全性和有效性，随访时间长达 5 年。
本分析评估了 Amulet 研究性器械豁免试验中 3 年的器械效果。
通过 3 年的时间报告了药物治疗方案和主要临床结局，包括：1）缺血性卒中和全身性栓塞（SE）的复合终点；2）所有卒中和 SE 或心血管（CV）死亡的复合终点；3）主要出血；4）全因死亡和 CV 死亡。
共有 108 个地点的 1878 名患者被随机分组。与 Watchman 相比，Amulet 组在 3 年内有更高比例的患者无需使用口服抗凝药物，分别为 96.2%和 92.5%（P<0.01）。在缺血性卒中和 SE 的复合终点方面，两组结果无显著差异（5.0% vs 4.6%；P=0.69）；在所有卒中和 SE 或 CV 死亡的复合终点方面，两组结果也无显著差异（11.1% vs 12.7%；P=0.31）；在主要出血方面，两组结果无显著差异（16.1% vs 14.7%；P=0.46）；在全因死亡方面，两组结果无显著差异（14.6% vs 17.9%；P=0.08）；在 CV 死亡方面，两组结果无显著差异（6.6% vs 8.5%；P=0.14）。通过 3 年的随访，Watchman 组中与器械相关的血栓或器械周围漏≥3mm 的器械因素比 Amulet 组更频繁地导致缺血性卒中和 CV 死亡事件的发生。
在高危人群中，Amulet 封堵器与 Watchman 装置相比，通过 3 年的随访，超过 96%的患者无需使用口服抗凝药物，安全性和有效性得到持续验证。（Amplatzer Amulet LAA Occluder 试验[Amulet IDE]；NCT02879448）。
