Faculdade Israelita de Ciências da Saúde Albert Einstein, Rua Comendador Elias Jafet, 755- São Paulo, São Paulo, 05653-000, Brazil.
Universidade Federal do Rio de Janeiro, Rua Professor Rodolpho Paulo Rocco, 255- Rio de Janeiro, Rio de Janeiro, 21941-617, Brazil.
Curr Probl Cardiol. 2025 Jan;50(1):102880. doi: 10.1016/j.cpcardiol.2024.102880. Epub 2024 Oct 10.
Direct Oral Anticoagulants (DOACs) are the first line anticoagulation for patients with non-valvular atrial fibrillation (NVAF). Percutaneous Left Atrial Appendage Occlusion (LAAO) has emerged as a new therapy and its safety and effectiveness compared with DOACs are still controversial.
A systematic review of randomized controlled trials and observational studies was conducted, focusing on patients with NVAF. Outcomes analyzed included: (1) all-cause mortality; (2) cardiovascular (CV) mortality; (3) thromboembolic events; (4) stroke or transient ischemic attack (TIA); (5) bleeding events; and a (6) composite of death, hemorrhagic, and thromboembolic events. We performed a subgroup analysis of major bleeding according to different definitions: (1) Bleeding Academic Research Consortium (BARC); (2) International Society on Thrombosis and Haemostasis (ISTH); and (3) other definitions.
Ten studies involving 18,507 patients were included, with 42.35 % undergoing LAAO. In pooled analysis, LAAO was associated with lower rates of all-cause mortality (HR 0.63; 95 % CI 0.50-0.80), cardiovascular mortality (HR 0.56; 95 % CI 0.45-0.70), and of the composite outcome (HR 0.73; 95 % CI 0.58-0.92). A trend towards lower stroke/TIA events was observed but not statistically significant. Overall bleeding events did not significantly differ between groups; using the ISTH definition, LAAO showed significantly lower incidence of bleeding events (HR 0.63; 95 % CI 0.43-0.91). No difference was found in thromboembolic events.
LAAO was associated with a significantly lower all-cause mortality and cardiovascular mortality, as well as the composite of death, hemorrhagic or thromboembolic events, as compared with DOACs.
直接口服抗凝剂（DOACs）是治疗非瓣膜性心房颤动（NVAF）患者的一线抗凝药物。经皮左心耳封堵术（LAAO）已成为一种新的治疗方法，但其与 DOACs 相比的安全性和有效性仍存在争议。
对 NVAF 患者的随机对照试验和观察性研究进行了系统评价。分析的结局包括：（1）全因死亡率；（2）心血管死亡率；（3）血栓栓塞事件；（4）卒中和短暂性脑缺血发作（TIA）；（5）出血事件；（6）死亡、出血和血栓栓塞事件的复合结局。我们根据不同的定义对主要出血事件进行了亚组分析：（1）Bleeding Academic Research Consortium（BARC）；（2）国际血栓与止血学会（ISTH）；（3）其他定义。
共纳入 10 项研究，涉及 18507 例患者，其中 42.35%的患者行 LAAO。汇总分析显示，LAAO 与较低的全因死亡率（HR 0.63；95%CI 0.50-0.80）、心血管死亡率（HR 0.56；95%CI 0.45-0.70）和复合结局（HR 0.73；95%CI 0.58-0.92）相关。虽观察到卒中/TIA 事件发生率呈下降趋势，但无统计学意义。两组总体出血事件发生率无显著差异；采用 ISTH 定义，LAAO 组出血事件发生率显著降低（HR 0.63；95%CI 0.43-0.91）。血栓栓塞事件发生率无差异。
与 DOACs 相比，LAAO 可显著降低全因死亡率、心血管死亡率以及死亡、出血或血栓栓塞事件的复合结局。
