Department of Medicine, Dow University of Health Sciences, Karachi, Pakistan.
Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA.
Catheter Cardiovasc Interv. 2022 Jun;99(7):2101-2110. doi: 10.1002/ccd.30213. Epub 2022 Apr 27.
The efficacy and safety of novel oral anticoagulants (NOACs) compared to the current guideline-recommended vitamin K antagonists (VKAs) in atrial fibrillation (AF) patients undergoing transcatheter aortic valve replacement (TAVR) has not been well established. We pooled evidence from all available studies to assess the risks and benefits of this drug class.
We queried electronic databases (MEDLINE, Scopus, and Cochrane central) up until January 28th, 2022 for studies comparing NOACs to VKAs in AF patients undergoing TAVR. Results from studies were presented as risk ratios (RR) and pooled using a random-effects model. Subgroup analysis by study design and meta-regression analysis were performed to explore heterogeneity.
A total of 12 studies (3 RCTs and 9 observational) containing 12,203 patients (mean age 81.2 years; 50.5% men) were identified and included in the analysis. Pooled analysis revealed no significant difference between NOACs and VKAs in terms of stroke or systemic embolism (RR: 0.78; p = 0.18), major bleeding (RR: 0.84; p = 0.32), intracranial hemorrhage (RR 0.61; p = 0.06), all-cause mortality (RR: 0.69; p = 0.07), and myocardial infarction (RR: 1.60; p = 0.24) at a mean length of follow-up of 15.1 months. RCTs and observational studies did not significantly differ across outcomes on subgroup analysis. Meta-regression analysis found heterogeneity in all-cause mortality to be significantly explained by percentage of males (coefficient: 0.049, p = 0.007), mean age (coefficient: 0.221, p < 0.001), and CHA2DS2-VASc score (coefficient: -1.657, p < 0.001).
This meta-analysis suggests that outcomes with NOACs do not significantly differ compared to VKAs following TAVR in patients with AF.
新型口服抗凝剂（NOACs）与目前指南推荐的维生素 K 拮抗剂（VKAs）在接受经导管主动脉瓣置换术（TAVR）的心房颤动（AF）患者中的疗效和安全性尚未得到充分证实。我们汇总了所有可用研究的证据，以评估该类药物的风险和获益。
我们检索了电子数据库（MEDLINE、Scopus 和 Cochrane 中心），截至 2022 年 1 月 28 日，以比较 AF 患者接受 TAVR 时使用 NOACs 与 VKAs 的研究。研究结果以风险比（RR）呈现，并采用随机效应模型进行汇总。我们进行了研究设计的亚组分析和荟萃回归分析，以探索异质性。
共纳入 12 项研究（3 项 RCT 和 9 项观察性研究），共包含 12203 名患者（平均年龄 81.2 岁；50.5%为男性）。汇总分析显示，NOACs 与 VKAs 在卒中或全身性栓塞（RR：0.78；p=0.18）、大出血（RR：0.84；p=0.32）、颅内出血（RR：0.61；p=0.06）、全因死亡率（RR：0.69；p=0.07）和心肌梗死（RR：1.60；p=0.24）方面无显著差异，平均随访时间为 15.1 个月。RCT 和观察性研究在亚组分析中，各结局的差异均无统计学意义。荟萃回归分析发现，全因死亡率的异质性可由男性比例（系数：0.049，p=0.007）、平均年龄（系数：0.221，p<0.001）和 CHA2DS2-VASc 评分（系数：-1.657，p<0.001）显著解释。
本荟萃分析表明，在 AF 患者中，与 VKAs 相比，NOACs 用于 TAVR 后结局无显著差异。
