NVAF患者左心耳封堵术后双联抗血小板治疗与单药抗血小板治疗临床疗效的荟萃分析

Comparison of clinical outcomes of dual versus single antiplatelet therapy after left atrial appendage occlusion in patients with high bleeding risk or contraindications for oral anticoagulant:a study-level Meta-analysis

目的荟萃分析左心耳封堵术(LAAC)后双联抗血小板治疗(dual-antiplatelet therapy,DAPT)与单药抗血小板治疗(single-antiplatelet therapy,SAPT)高出血风险或不耐受口服抗凝药物的非瓣膜性心房颤动(NVAF)患者的有效性与安全性。方法采取主题词与自由词相结合进行文献检索,主题词检索时采用扩展检索组配全部副主题词,由2名研究者独立筛选文献,提交资料并交叉核对,如遇分歧则讨论解决,或交由第三名研究者协助判断。计算机检索PubMed、EMBASE、The Cochrane Library数据库、临床试验注册中心,纳入2012年1月1日~2023年4月1日对比LAAC术后DAPT与SAPT抗栓治疗的临床研究。研究观察终点包括缺血性脑卒中(ischemia stroke,IS),大出血以及器械相关血栓(device-related thrombus,DRT)。本研究共纳入18项非随机对照试验共3637例患者,其中DAPT组2479例,DES组1158例。结果DAPT组IS发生率有低于SAPT组的趋势(2.5%vs.3.3%,OR:0.75,95%CI:0.40~1.42,P=0.380,I^(2)=0%),但差异无统计学意义。DAPT组大出血发生率有高于SAPT组的趋势(5.4%vs.4.3%,OR:0.91,95%CI:0.46~1.79,P=0.790,I^(2)=52%),但差异无统计学意义;去除异质性来源Vignali-2023研究后,高质量文献亚组,DAPT组大出血发生率显著高于SAPT组(6.5%vs.2.3%,OR:2.64,95%CI:1.23~5.68,P=0.010,I^(2)=0%),差异有统计学意义(P<0.05)。DAPT组与SAPT组DRT发生率相近(2.5%vs.2.7%,OR:0.68,95%CI:0.42~1.12,P=0.130,I^(2)=0%),但差异无统计学意义。结论对于高出血风险或无法耐受口服抗凝药物治疗的NVAF患者,LAAC术后DAPT与SAPT预防IS与DRT事件同样有效,SAPT大出血发生率低于DAPT,但差异无统计学意义。

AIM To the optimal antiplatelet strategy after left atrial appendage closure(LAAC)in patients with high bleeding risk or absolute contraindications for oral anticoagulant is unclear.This study aims to compare DAPT with SAPT for efficacy and safety in patients undergoing LAAC.METHODS A database search was conducted using PubMed,EMBASE,Cochrane Library,and Clinicaltrials.gov for trials that compared DAPT with SAPT after LAAC.The outcomes included ischemic stroke(IS),major bleeding and device-related thrombus(DRT).We included 18 nonrandomized clinical trials with 3637 patients,of whom 2479 patients received DAPT,while 1158 patients received SAPT.RESULTS The DAPT group had lower IS than the SAPT group(2.5%vs.3.3%,OR:0.75,95%CI:0.40~1.42,P=0.380,I^(2)=0%),the difference was not statistically significant.There was no significant difference about major bleeding between groups(5.4%vs.4.3%,OR:0.91,95%CI:0.46~1.79,P=0.790,I^(2)=52%).When Vagnali-203 was excluded,major bleeding was significantly higher(P<0.05)in the DAPT group than SAPT group(6.5%vs.2.3%,OR:2.64,95%CI:1.23~5.68,P=0.010,I^(2)=0%)in high-quality study subgroup.DRT was comparable between two groups(2.5%vs.2.7%,OR:0.68,95%CI:0.42~1.12,P=0.130,I^(2)=0%).CONCLUSIONS In patients who underwent LAA occlusion,post-procedural use of SAPT instead of DAPT is associated with a trend of major bleeding reduction,with no significant increase in the risk of thrombotic events.