Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic.
Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic.
J Am Coll Cardiol. 2022 Jan 4;79(1):1-14. doi: 10.1016/j.jacc.2021.10.023. Epub 2021 Nov 5.
The PRAGUE-17 (Left Atrial Appendage Closure vs Novel Anticoagulation Agents in Atrial Fibrillation) trial demonstrated that left atrial appendage closure (LAAC) was noninferior to nonwarfarin direct oral anticoagulants (DOACs) for preventing major neurological, cardiovascular, or bleeding events in patients with atrial fibrillation (AF) who were at high risk.
This study sought to assess the prespecified long-term (4-year) outcomes in PRAGUE-17.
PRAGUE-17 was a randomized noninferiority trial comparing percutaneous LAAC (Watchman or Amulet) with DOACs (95% apixaban) in patients with nonvalvular AF and with a history of cardioembolism, clinically-relevant bleeding, or both CHADS-VASc ≥3 and HASBLED ≥2. The primary endpoint was a composite of cardioembolic events (stroke, transient ischemic attack, or systemic embolism), cardiovascular death, clinically relevant bleeding, or procedure-/device-related complications (LAAC group only). The primary analysis was modified intention-to-treat.
This study randomized 402 patients with AF (201 per group, age 73.3 ± 7.0 years, 65.7% male, CHADS-VASc 4.7 ±1.5, HASBLED 3.1 ± 0.9). After 3.5 years median follow-up (1,354 patient-years), LAAC was noninferior to DOACs for the primary endpoint by modified intention-to-treat (subdistribution HR [sHR]: 0.81; 95% CI: 0.56-1.18; P = 0.27; P for noninferiority = 0.006). For the components of the composite endpoint, the corresponding sHRs were 0.68 (95% CI: 0.39-1.20; P = 0.19) for cardiovascular death, 1.14 (95% CI: 0.56-2.30; P = 0.72) for all-stroke/transient ischemic attack, 0.75 (95% CI: 0.44-1.27; P = 0.28) for clinically relevant bleeding, and 0.55 (95% CI: 0.31-0.97; P = 0.039) for nonprocedural clinically relevant bleeding. The primary endpoint outcomes were similar in the per-protocol (sHR: 0.80; 95% CI: 0.54-1.18; P = 0.25) and on-treatment (sHR: 0.82; 95% CI: 0.56-1.20; P = 0.30) analyses.
In long-term follow-up of PRAGUE-17, LAAC remains noninferior to DOACs for preventing major cardiovascular, neurological, or bleeding events. Furthermore, nonprocedural bleeding was significantly reduced with LAAC. (PRAGUE-17 [Left Atrial Appendage Closure vs Novel Anticoagulation Agents in Atrial Fibrillation]; NCT02426944).
PRAGUE-17（左心耳封堵 vs 房颤新型抗凝药物）试验表明，对于伴有高卒中风险的非瓣膜性房颤患者，左心耳封堵（LAAC）在预防主要神经、心血管或出血事件方面不劣于非华法林直接口服抗凝剂（DOACs）。
本研究旨在评估 PRAGUE-17 的预设 4 年长期结局。
PRAGUE-17 是一项随机非劣效性试验，比较了经皮 LAAC（Watchman 或 Amulet）与 DOACs（95%阿哌沙班）在非瓣膜性房颤且有栓塞史、有临床相关出血史或两者均有的患者中的应用。主要终点是栓塞性事件（卒、短暂性脑缺血发作或全身性栓塞）、心血管死亡、有临床意义的出血或与手术/器械相关的并发症的复合终点（仅 LAAC 组）。主要分析采用意向治疗的改良分析。
本研究随机纳入了 402 例房颤患者（每组 201 例，年龄 73.3±7.0 岁，65.7%为男性，CHA2DS2-VASc 评分为 4.7±1.5，HAS-BLED 评分为 3.1±0.9）。在 3.5 年的中位随访（1354 患者-年）后，LAAC 在改良意向治疗的主要终点方面不劣于 DOACs（校正亚分布风险比[sHR]：0.81；95%置信区间：0.56-1.18；P=0.27；非劣效性 P 值=0.006）。对于复合终点的各个组成部分，相应的 sHR 分别为：心血管死亡（sHR：0.68；95%置信区间：0.39-1.20；P=0.19）、全卒中/短暂性脑缺血发作（sHR：1.14；95%置信区间：0.56-2.30；P=0.72）、有临床意义的出血（sHR：0.75；95%置信区间：0.44-1.27；P=0.28）和非手术相关有临床意义的出血（sHR：0.55；95%置信区间：0.31-0.97；P=0.039）。在符合方案分析（sHR：0.80；95%置信区间：0.54-1.18；P=0.25）和治疗分析（sHR：0.82；95%置信区间：0.56-1.20；P=0.30）中，主要终点结局相似。
在 PRAGUE-17 的长期随访中，LAAC 在预防主要心血管、神经或出血事件方面仍然不劣于 DOACs。此外，LAAC 可显著减少非手术相关出血。（PRAGUE-17 [左心耳封堵 vs 房颤新型抗凝药物]；NCT02426944）。
