比较Amulet与Watchman FLX用于房颤患者左心耳封堵的3年临床结局：SWISS-APERO随机临床试验结果
3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial.
作者信息
Galea Roberto, De Marco Federico, Aminian Adel, Meneveau Nicolas, Chalkou Konstantina, Anselme Frederic, Gräni Christoph, Franzone Anna, Vranckx Pascal, Fischer Urs, Valgimigli Marco, Räber Lorenz
机构信息
Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland; Department of Cardiology, Hospital Centre of Biel, Biel, Switzerland.
Department of Cardiology, Monzino Cardiology Center, Milan, Italy.
出版信息
J Am Coll Cardiol. 2025 Jul 8;86(1):3-14. doi: 10.1016/j.jacc.2025.03.535.
BACKGROUND
No study thus far has compared Amulet with Watchman FLX for clinical outcomes beyond 1 year after percutaneous left atrial appendage closure (LAAC).
OBJECTIVES
The goal of this study was to compare Amulet and Watchman FLX in terms of 3-year clinical outcomes.
METHODS
In the investigator-initiated SWISS-APERO (Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure) trial, patients with atrial fibrillation and high bleeding risk undergoing LAAC were randomly assigned (1:1) to receive Amulet or Watchman/FLX across 8 centers. Study endpoint included the composite of cardiovascular death, stroke, transient ischemic attack, or systemic embolism at 3 years. Analyses were repeated in the as-treated (AT) and per-protocol (PP) populations.
RESULTS
Of the 221 patients randomized to treatment, 220 completed LAAC and 3 patients randomized to receive the Amulet device received the Watchman FLX device. The follow-up rate at 3 years was 96.4% in the Amulet group and 97.3% in the Watchman group. The composite ischemic endpoint occurred numerically less frequently in the Amulet group compared with the Watchman group (18.2% vs 31.0%; HR: 0.58; 95% CI: 0.33-1.03; P = 0.06). In both the AT (17.0% vs 31.1%; HR: 0.53; 95% CI: 0.30-0.96; P = 0.035) and PP (16.2% vs 29.2%; HR: 0.54; 95% CI: 0.29-1.00; P = 0.049) populations, the composite ischemic endpoint was significantly lower in the Amulet group compared with the Watchman group.
CONCLUSIONS
At 3 years after LAAC, there was no significant difference in the ischemic risk between the Amulet and the Watchman FLX groups. The lower occurrence of the ischemic composite endpoint observed in the Amulet group in both the AT and PP analyses is hypothesis generating and emphasizes the need for further studies. (Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure [SWISS-APERO]; NCT03399851).
背景
迄今为止，尚无研究比较经皮左心耳封堵术（LAAC）后1年以上使用Amulet和Watchman FLX的临床结局。
目的
本研究的目的是比较Amulet和Watchman FLX在3年临床结局方面的差异。
方法
在研究者发起的SWISS-APERO（接受左心耳封堵术患者中Amplatzer Amulet与Watchman装置的比较）试验中，将有房颤且出血风险高且接受LAAC的患者随机分配（1:1），在8个中心接受Amulet或Watchman/FLX治疗。研究终点包括3年时心血管死亡、中风、短暂性脑缺血发作或全身性栓塞的复合终点。在接受治疗（AT）和符合方案（PP）的人群中重复进行分析。
结果
在随机接受治疗的221例患者中，220例完成了LAAC，3例随机接受Amulet装置的患者接受了Watchman FLX装置。Amulet组3年时的随访率为96.4%，Watchman组为97.3%。与Watchman组相比，Amulet组复合缺血终点的发生次数在数值上较少（18.2%对31.0%；HR：0.58；95%CI：0.33-1.03；P=0.06）。在AT人群（17.0%对31.1%；HR：0.53；95%CI：0.30-0.96；P=0.035）和PP人群（16.2%对29.2%；HR：0.54；95%CI：0.29-1.00；P=0.049）中，与Watchman组相比，Amulet组的复合缺血终点均显著更低。
结论
LAAC后3年，Amulet组和Watchman FLX组在缺血风险方面无显著差异。在AT分析和PP分析中，Amulet组观察到的复合缺血终点发生率较低，这一现象有待进一步研究证实，并强调了进一步研究的必要性。（接受左心耳封堵术患者中Amplatzer Amulet与Watchman装置的比较[SWISS-APERO]；NCT03399851）
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