Núcleo de Avaliação de Tecnologias em Saúde da Unimed do Brasil, Unimed do Brasil, São Paulo, SP, Brazil.
Núcleo de Avaliação de Tecnologias em Saúde da Unimed do Brasil, Unimed do Brasil, São Paulo, SP, Brazil.
Clinics (Sao Paulo). 2024 Aug 30;79:100465. doi: 10.1016/j.clinsp.2024.100465. eCollection 2024.
With the aim of reducing the risk of Cerebrovascular Accident (CVA) in patients with Non-Valvular Atrial Fibrillation (NVAF), Left Atrial Appendage Occlusion (LAAO) devices are emerging as an alternative to oral anticoagulants.
To analyze the efficacy and safety of the LAAO procedure in patients with NVAF and contraindications and/or failure for oral anticoagulants.
The search for evidence was carried out in the electronic databases Medline and Embase till January 2024. Additional searches were conducted on Google Scholar. The clinical trials registry database was also consulted. Two blinded investigators performed the search, study selection, and data collection, and assessed quality and risk of bias using the Cochrane tool for randomized clinical trials. Meta-analyses of eligible trials were performed using RevMan 5.4.1 software. The random effects model was used for all analyses.
Five articles were selected, among which three were non-inferiority randomized clinical trials that analyzed the performance and safety of LAAO devices compared to the use of Vitamin K Antagonists (AVKs) or Novel Oral Anticoagulants (NOACs). No randomized clinical trials were found that analyzed populations with absolute contraindications to oral anticoagulants. Having as primary outcomes analyzed the occurrence of stroke (ischemic or hemorrhagic), cardiovascular or unexplained death and systemic embolism, the non-inferiority of the LAAO procedure compared to the use of oral anticoagulants was verified.
For patients with an absolute contraindication to anticoagulation and/or failure to use oral anticoagulants, evidence for the use of LAAO devices is scarce.
为降低非瓣膜性心房颤动(NVAF)患者发生脑血管意外(CVA)的风险,左心耳封堵(LAAO)装置作为口服抗凝剂的替代方法逐渐兴起。
分析 LAAO 术在 NVAF 合并口服抗凝剂禁忌证和/或不耐受患者中的疗效和安全性。
在 Medline 和 Embase 电子数据库中进行证据检索,检索时间截至 2024 年 1 月。还在 Google Scholar 上进行了额外的搜索。同时还查阅了临床试验注册数据库。由两名盲法调查员进行检索、研究选择和数据收集,并使用 Cochrane 随机临床试验工具评估质量和偏倚风险。使用 RevMan 5.4.1 软件对合格试验进行荟萃分析。所有分析均采用随机效应模型。
共选择了 5 篇文章,其中 3 篇为非劣效性随机临床试验,分析了 LAAO 装置与维生素 K 拮抗剂(AVKs)或新型口服抗凝剂(NOACs)的使用相比的性能和安全性。未发现分析对口服抗凝剂有绝对禁忌证的人群的随机临床试验。将卒中(缺血性或出血性)、心血管或不明原因死亡和全身栓塞的发生作为主要结局进行分析,验证了 LAAO 术与口服抗凝剂相比的非劣效性。
对于绝对抗凝禁忌和/或不能使用口服抗凝剂的患者,LAAO 装置的使用证据有限。