左心耳封堵患者新型口服抗凝药与华法林单药治疗的疗效比较：一项系统评价和荟萃分析。
Comparison of outcomes between novel oral anticoagulants and warfarin monotherapy in patients with left atrial appendage closure: A systematic review and meta-analysis.
作者信息
Sun Bing, Chen Rui Rui, Gao Chao, Tao Ling
机构信息
Department of Cardiology, Xijing Hospital, Air Force Medical University, Xi'an, China.
Department of Cardiology, Tangdu Hospital, Air Force Medical University, Xi'an, China.
出版信息
Front Cardiovasc Med. 2022 Oct 24;9:1023941. doi: 10.3389/fcvm.2022.1023941. eCollection 2022.
BACKGROUND
Pivotal trials of percutaneous left atrial appendage closure (LAAC) used dedicated post-procedure antithrombotic protocols. However, there is no consensus on the selection of new oral anticoagulants (NOAC) and warfarin monotherapy after LAAC. This study aims to compare NOAC with warfarin monotherapy 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 NOAC with warfarin monotherapy after LAAC. The effective outcomes included any major adverse events (all-cause death, stroke, major bleeding) and their individual components. Safety outcomes included all-cause death, major bleeding, total bleeding, DRT, and PDL >5 mm.
RESULTS
We included 10 non-randomized clinical trials with 10,337 patients, of whom 4,960 patients received NOAC, while 5,377 patients received warfarin. There were no statistically significant differences in any major adverse events (LogOR: -0.11, 95% CI: -0.27, 0.04, = 0.16), stroke (LogOR: 0.00, 95% CI: -0.42, 0.42, = 1.00), all-cause death (LogOR: -0.23, 95% CI: -0.48, 0.02, = 0.07), major bleeding (LogOR: -0.22, 95% CI: -0.45, 0.01, = 0.06). NOAC was associated with a significant reduction in total bleeding (LogOR: -1.01, 95% CI: -1.47, -0.55, < 0.0001) compared to warfarin. No statistically significant differences were found in DRT (LogOR: -0.19, 95% CI: -0.15, 0.52, = 0.27) and PDL >5 mm (LogOR: 0.19, 95% CI: -0.33, 0.72, = 0.47). Meta-regression and subgroup analysis showed that total bleeding (LogOR: -1.56, 95% CI: -2.15, -0.97, < 0.001) was significantly lower in the NOAC group in the subgroup of <75 y.
CONCLUSION
After LAAC, NOAC monotherapy was associated with a lower risk of bleeding compared to warfarin monotherapy for 45 days. There was no significant difference between NOAC and warfarin in terms of other results.
SYSTEMATIC REVIEW REGISTRATION
www.york.ac.uk/inst/crd, identifier: CRD42022361244.
背景
经皮左心耳封堵术（LAAC）的关键试验采用了专门的术后抗血栓形成方案。然而，对于LAAC术后新型口服抗凝药（NOAC）和华法林单药治疗的选择尚无共识。本研究旨在比较NOAC与华法林单药治疗在LAAC患者中的疗效和安全性。
方法
使用PubMed、EMBASE、Cochrane图书馆和Clinicaltrials.gov进行数据库检索，以查找比较LAAC术后NOAC与华法林单药治疗的试验。有效结局包括任何主要不良事件（全因死亡、中风、大出血）及其各个组成部分。安全结局包括全因死亡、大出血、总出血、封堵器相关血栓形成（DRT）和心包积液（PDL）>5mm。
结果
我们纳入了10项非随机临床试验，共10337例患者，其中4960例患者接受NOAC治疗，5377例患者接受华法林治疗。在任何主要不良事件（对数比值比：-0.11，95%置信区间：-0.27，0.04，P = 0.16）、中风（对数比值比：0.00，95%置信区间：-0.42，0.42，P = 1.00）、全因死亡（对数比值比：-0.23，95%置信区间：-0.48，0.02，P = 0.07）、大出血（对数比值比：-0.22，95%置信区间：-0.45，0.01，P = 0.06）方面，均无统计学显著差异。与华法林相比，NOAC与总出血显著减少相关（对数比值比：-1.01，95%置信区间：-1.47，-0.55，P < 0.0001）。在DRT（对数比值比：-0.19，95%置信区间：-0.15，0.52，P = 0.27）和PDL>5mm（对数比值比：0.19，95%置信区间：-0.33，0.72，P = 0.47）方面未发现统计学显著差异。Meta回归和亚组分析显示，在<75岁亚组中，NOAC组的总出血（对数比值比：-1.56，95%置信区间：-2.15，-0.97，P < 0.001）显著更低。
结论
LAAC术后，与华法林单药治疗相比，NOAC单药治疗在45天内出血风险更低。在其他结果方面，NOAC与华法林之间无显著差异。
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