新型口服抗凝剂在左心耳封堵术后运用的疗效与安全性的meta分析

Meta analysis of efficacy and safety of a new oral anticoagulant after left atrial appendage closure

目的:评估新型口服抗凝剂(NOAC)应用于左心耳封堵术(LAAC)后患者的疗效以及安全性。方法:计算机检索中国知网(CNKI)、维普(VIP)、万方、中国生物医学文献数据库(CMB)、Pubmed、Embase、Cochrane Library数据库,检索范围为2000年—2022年11月。检验漏斗图的对称性以评估纳入研究有无偏倚,应用Revman5.3合并RR值进行meta分析。结果:最终纳入12篇文献,其中前瞻性队列研究1篇和回顾性队列研究11篇,总计13 480例研究对象。Meta分析结果显示,与标准治疗方案相比,NOAC对围手术期不良事件减少相关(RR=0.39,95%CI 0.21~0.73,P<0.05;I~2=16%,P=0.31),随访45 d内对器械相关血栓(DRT)事件(RR=0.68,95%CI 0.49~0.96,P=0.03;I~2=0%,P=0.45)、大出血事件(RR=0.54,95%CI 0.39~0.75,P<0.05;I~2=0%,P=0.96)、所有出血事件(RR=0.27,95%CI 0.14~0.54,P<0.05;I~2=0%,P=0.49)、全因死亡事件(RR=0.55,95%CI 0.44~0.69,P<0.05;I~2=0.82,P=0.82)减少相关,与复合栓塞事件无统计学差异(RR=0.88,95%CI 0.221~3.49,P=0.86;I~2=46%,P=0.10),在平均随访期45~868 d内,与华法林相比,NOAC对复合栓塞事件(RR=0.60,95%CI 0.45~0.81,P<0.05;I~2=0%,P=0.45)、DRT事件(RR=0.68,95%CI 0.50~0.93,P=0.02;I~2=26%,P=0.22)、大出血事件(RR=0.53,95%CI 0.44~0.64,P<0.05;I~2=0%,P=0.66)、所有出血事件(RR=0.45,95%CI 0.28~0.72,P<0.05;I~2=9%,P=0.36)、全因死亡事件(RR=0.51,95%CI 0.44~0.60,P<0.05;I~2=0%,P=1.00)减少相关,与残余漏(PDL)>5 mm(RR=0.75,95%CI 0.44~1.29,P=0.30;I~2=0%,P=0.32)无统计学差异。讨论:NOAC在左心耳封堵术后的应用具有良好的疗效与安全性,对围手术期不良事件以及随访期内DRT形成、大出血、所有出血事件、全因死亡事件的发生优于华法林治疗。

Objective: To evaluate the efficacy and safety of a new oral anticoagulant(NOAC) in patients after left atrial appendage occlusion(LAAC). Methods: The computer searches CNKI, VIP, Wanfang, China Biomedical Literature Database(CMB), Pubmed, Embase, and Cochrane Library databases from 2000 to November 2022. The symmetry of funnel chart was tested to assess whether the included studies were biased. Revman 5.3 was used to combine RR values for Meta-analysis. Results: 12 articles were finally included, including 1 prospective cohort study and 11 retrospective cohort studies, with a total of 13, 480 subjects. Meta analysis results showed that compared with the standard treatment regimen, NOAC was associated with the reduction of adverse events during perioperative period(RR=0.39, 95%CI 0.21-0.73, P<0.05, I~2=16%, P=0.31). During the 45 days of follow-up, NOAC was associated with the reduction of DRT events(RR=0.68, 95%CI 0.49-0.96, P=0.03, I~2=0%, P=0.45), massive bleeding events(RR=0.54, 95%CI 0.39-0.75, P<0.05, I~2=0%, P=0.96), all bleeding events(RR=0.27, 95%CI 0.14-0.54, P<0.05, I~2=0%, P=0.49) The reduction of all-cause death events(RR=0.55, 95%CI 0.44-0.69, P<0.05, I~2=0.82, P=0.82) was related to the reduction of composite embolic events, and there was no statistical difference with composite embolic events(RR=0.88, 95%CI 0.221-3.49, P=0.86, I~2=46%, P=0.10). During the average follow-up period of 45 days to 868, compared with warfarin, NOAC was associated with composite embolic events(RR=0.60, 95%CI 0.45-0.81, P<0.05, I~2=0%, P=0.45), DRT events(RR=0.68, 95%CI 0.50-0.93, P=0.02, I~2=26%, P=0.22), massive hemorrhage events(RR=0.53, 95%CI 0.44-0.64, P<0.05, I~2=0%, P=0.66) The reduction of all bleeding events(RR=0.45, 95%CI 0.28-0.72, P<0.05, I~2=9%, P=0.36) and all-cause death events(RR=0.51, 95%CI 0.44-0.60, P<0.05, I~2=0%, P=1.00) was related to the reduction of residual leakage(PDL)5 mm.(RR=0.75, 95%CI 0.44-1.29, P=0.30, I~2=0%, P=0.32) Conclusion: The application of NOAC after left atrial appendage closure has good efficacy and safety, and is superior to warfarin in the treatment of adverse events in the perioperative period and the occurrence of DRT formation, massive hemorrhage, all bleeding events, and all cause death events during the follow-up period.