左心耳封堵术与口服抗凝药预防心房颤动患者卒中的最新荟萃分析。
完整摘要 · 中文译文
背景：非瓣膜性心房颤动中90%的左心房血栓起源于左心耳，左心耳可经皮封堵（左心耳封堵（left atrial appendage closure [LAAC]））。两项2026年试验（CHAMPION-AF[Watchman Flx对比非维生素K拮抗剂口服抗凝药用于非瓣膜性心房颤动患者管理中的栓塞保护]和CLOSURE-AF[心房颤动患者左心耳封堵与药物治疗的比较]）使比较LAAC与口服抗凝治疗的可用随机证据增加了一倍以上。我们按出血风险、抗凝适用性和对照措施评估了LAAC对卒中、出血和死亡率的合并效应。方法：在这项系统评价和荟萃分析中，我们检索了PubMed、Scopus和Embase从建库至2026年4月15日的资料，以查找比较经皮LAAC与口服抗凝治疗在非瓣膜性心房颤动中应用的随机对照试验。偏倚风险采用Cochrane偏倚风险2工具评估。累积发生率结局以比值比采用随机效应模型合并，并计算预测区间、进行预设亚组分析和试验序贯分析。结果：6项随机对照试验（2014—2026年；北美、欧洲和亚洲358个中心；7028例患者）比较了LAAC与华法林（2项试验）或直接口服抗凝药（4项试验）；人群主要为符合抗凝条件且既往卒中患病率低者，另有2项高出血风险试验和1项消融后试验。总体卒中率在两组间相似（odds 比值，1.10 [95% CI，0.78-1.56]）。缺血性卒中在LAAC组更常见（比值比，1.41 [95% CI，1.07-1.86]），但未达到所需信息量。非操作相关出血在LAAC组较低（比值比，0.58 [95% CI，0.35-0.96]），这是唯一达到足够信息量的结局，见于标准风险和消融术后患者，而非高出血风险患者。 结论：LAAC最适合用于降低符合抗凝治疗标准且出血风险为中低程度的患者的非操作相关出血，而非作为口服抗凝治疗的卒中等效替代方案。 注册：网址：https://www.crd.york.ac.uk/PROSPERO/；唯一标识号：CRD420261370546。
完整摘要 · 英文原文
BACKGROUND: Ninety percent of left atrial thrombi in nonvalvular atrial fibrillation arise in the left atrial appendage, which can be occluded percutaneously (left atrial appendage closure [LAAC]). Two 2026 trials (CHAMPION-AF [Watchman Flx Versus Non-Vitamin K Antagonist Oral Anticoagulant for Embolic Protection in the Management of Patients With Non-Valvular Atrial Fibrillation] and CLOSURE-AF [Left Atrial Appendage Closure in Patients With Atrial Fibrillation Compared to Medical Therapy]) more than doubled the available randomized evidence comparing LAAC with oral anticoagulation. We evaluated pooled effects of LAAC on stroke, bleeding, and mortality by bleeding risk, anticoagulation eligibility, and comparator. METHODS: In this systematic review and meta-analysis, we searched PubMed, Scopus, and Embase from inception to April 15, 2026, for randomized controlled trials comparing percutaneous LAAC with oral anticoagulation in nonvalvular atrial fibrillation. Risk of bias was assessed with the Cochrane Risk of Bias 2 tool. Cumulative-incidence outcomes were pooled as odds ratios using random-effects models, with prediction intervals, prespecified subgroups, and trial sequential analysis. RESULTS: Six randomized controlled trials (2014-2026; 358 sites in North America, Europe, and Asia; 7028 patients) compared LAAC with warfarin (2 trials) or a direct oral anticoagulant (4 trials); populations were predominantly anticoagulation-eligible with low prior-stroke prevalence, plus 2 high-bleeding-risk and 1 postablation trial. Overall stroke rates were similar between arms (odds ratio, 1.10 [95% CI, 0.78-1.56]). Ischemic stroke was more frequent with LAAC (odds ratio, 1.41 [95% CI, 1.07-1.86]) but did not reach the required information size. Nonprocedural bleeding was lower with LAAC (odds ratio, 0.58 [95% CI, 0.35-0.96]), the only outcome reaching a sufficient information size, in standard-risk and postablation but not high-bleeding-risk patients. CONCLUSIONS: LAAC is best positioned to reduce nonprocedural bleeding in anticoagulation-eligible patients at standard-to-moderate bleeding risk, rather than as a stroke-equivalent substitute for oral anticoagulation. REGISTRATION: URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD420261370546.