Cardiovascular Department Humanitas Gavazzeni Hospital Bergamo Italy.
Department of Biomedical Sciences Humanitas University Pieve Emanuele MI Italy.
J Am Heart Assoc. 2024 Aug 20;13(16):e034815. doi: 10.1161/JAHA.124.034815. Epub 2024 Aug 9.
Percutaneous left atrial appendage closure (LAAC) has been suggested as an alternative to long-term oral anticoagulation for nonvalvular atrial fibrillation, but comparative data remain scarce. We aimed to assess ischemic and bleeding outcomes of LAAC compared with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) for the prevention of cardioembolic events in patients with atrial fibrillation.
Embase and MEDLINE were searched for randomized trials comparing LAAC, VKAs, and DOACs. The primary efficacy end point was any stroke or systemic embolism. Treatment effects were calculated from a network meta-analysis and ranked according to the surface under the cumulative ranking curve. Seven trials and 73 199 patients were included. The risk of the primary end point was not statistically different between LAAC versus VKAs (odds ratio [OR], 0.92 [95% CI, 0.62-1.50]) and LAAC versus DOACs (OR, 1.11 [95% CI, 0.71-1.73]). LAAC and DOACs resulted in similar risk of major or minor (OR, 0.93 [95% CI, 0.61-1.42]) and major bleeding (OR, 0.92 [95% CI, 0.58-1.46]); however, after exclusion of procedural bleeding, bleeding risk was significantly lower in those undergoing LAAC. Both LAAC and DOACs reduced the risk of all-cause death compared with VKAs (LAAC versus VKAs: OR, 0.70 [95% CI, 0.53-0.91]; DOACs versus VKAs: OR, 0.90 [95% CI, 0.85-0.95], respectively). DOACs ranked as the best treatment for stroke or systemic embolism prevention (66.9%) and LAAC for reducing major bleeding (63.9%) and death (96.4%).
As a nonpharmacological alternative to oral anticoagulation for atrial fibrillation, LAAC showed similar efficacy and safety compared with VKAs or DOACs. Prospective confirmation from larger studies is warranted.
经皮左心耳封堵术(LAAC)已被提议作为非瓣膜性心房颤动患者长期口服抗凝治疗的替代方法,但比较数据仍然很少。我们旨在评估 LAAC 与维生素 K 拮抗剂(VKA)或直接口服抗凝剂(DOAC)预防心房颤动患者心源性栓塞事件的缺血和出血结局。
Embase 和 MEDLINE 检索了比较 LAAC、VKA 和 DOAC 的随机试验。主要疗效终点是任何卒中和全身性栓塞。通过网络荟萃分析计算治疗效果,并根据累积排序曲线下面积进行排名。纳入 7 项试验和 73199 例患者。LAAC 与 VKA (比值比[OR],0.92[95%可信区间,0.62-1.50])和 LAAC 与 DOAC (OR,1.11[95%可信区间,0.71-1.73])之间的主要终点风险无统计学差异。LAAC 和 DOAC 的主要或次要(OR,0.93[95%可信区间,0.61-1.42])和主要出血(OR,0.92[95%可信区间,0.58-1.46])风险相似;然而,在排除程序出血后,接受 LAAC 的患者出血风险显著降低。与 VKA 相比,LAAC 和 DOAC 均降低全因死亡率(LAAC 与 VKA:OR,0.70[95%可信区间,0.53-0.91];DOAC 与 VKA:OR,0.90[95%可信区间,0.85-0.95])。DOAC 被评为预防卒中或全身性栓塞的最佳治疗方法(66.9%),LAAC 则是预防大出血(63.9%)和死亡(96.4%)的最佳治疗方法。
作为心房颤动患者口服抗凝的非药物替代方法,LAAC 与 VKA 或 DOAC 相比具有相似的疗效和安全性。需要更大规模的研究来证实。