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阿哌沙班与维生素K拮抗剂用于Heartmate 3全磁悬浮左心室辅助装置患者的疗效和安全性:一项综合荟萃分析。

Efficacy and safety of apixaban versus vitamin K antagonists in patients with heartmate 3 fully magnetically levitated left ventricular assist device: a comprehensive meta-analysis.

作者信息

Tripoli Andrea, Samaniego Miguel A, Gamarra-Valverde Norma N, Selvam Shivraj Paneer, Kaplinsky Edgardo, Barbagelata Alejandro, Scandroglio Anna Mara, Giorgi Juliana

机构信息

Cardiac Intensive Care Unit, San Raffaele Hospital, Università Vita-Salute San Raffaele, Milan, Italy.

Universidad Autónoma Metropolitana, Ciudad de México, Mexico.

出版信息

J Thromb Thrombolysis. 2025 Jul 1. doi: 10.1007/s11239-025-03141-y.

DOI:10.1007/s11239-025-03141-y
PMID:40593455
Abstract

BACKGROUND

Vitamin K antagonists (VKAs) are the first-line strategy for anticoagulation in patients with left ventricular assist devices (LVADs). Recently, the HeartMate 3 (HM3) LVAD, has shown lower thrombotic complications than previous technologies. Direct oral anticoagulants (DOACs) are emerging as an alternative for oral anticoagulation in this patient cohort. However, their safety and efficacy remain uncertain. As DOACs represent a drug class with differing characteristics, this meta-analysis will examine the influence of the Direct Factor Xa inhibitor Apixaban on HM3-LVAD.

METHODS

We systemically searched medical databases for studies comparing Apixaban and VKAs in patients supported with HM3. The primary outcome was hemocompatibility-related adverse events (HRAEs) and major bleeding. All-cause mortality, minor bleeding, all bleeding, thromboembolic events, and stroke were analyzed as secondary outcomes.

RESULTS

Five studies involving a total of 209 patients (119 on Apixaban and 90 on VKAs) were included. The incidence of the primary safety outcome for major bleeding was significantly reduced in the Apixaban group (RR 0.21; 95% CI 0.05-0.81; p = 0.023; I=0%). No statistically significant difference was found between Apixaban and VKA group in the analysis of the primary efficacy endpoint of HRAEs (RR 0.59; 95% CI 0.26-1.32; p = 0.204; I=0%). All-cause bleeding was also significantly reduced (RR 0.33; 95% CI 0.19-0.57; p = 0.005, I²=0%).

CONCLUSIONS

This meta-analysis showed that Apixaban reduced bleeding complications, comparable stroke prevention, and similar survival outcomes. These findings suggest that Factor Xa inhibitors may provide a safer and more patient-friendly alternative to warfarin, particularly in reducing gastrointestinal bleeding and improving anticoagulation management adherence.

摘要

背景

维生素K拮抗剂(VKAs)是左心室辅助装置(LVADs)患者抗凝治疗的一线策略。最近,HeartMate 3(HM3)左心室辅助装置显示出比以往技术更低的血栓形成并发症。直接口服抗凝剂(DOACs)正在成为该患者群体口服抗凝治疗的替代方案。然而,它们的安全性和有效性仍不确定。由于DOACs是一类具有不同特性的药物,本荟萃分析将研究直接因子Xa抑制剂阿哌沙班对HM3左心室辅助装置的影响。

方法

我们系统检索了医学数据库,以查找比较阿哌沙班和VKAs在接受HM3支持的患者中的研究。主要结局是血液相容性相关不良事件(HRAEs)和大出血。全因死亡率、小出血、所有出血、血栓栓塞事件和中风作为次要结局进行分析。

结果

纳入了5项研究,共209例患者(119例使用阿哌沙班,90例使用VKAs)。阿哌沙班组大出血的主要安全结局发生率显著降低(RR 0.21;95% CI 0.05 - 0.81;p = 0.023;I = 0%)。在HRAEs主要疗效终点分析中,阿哌沙班组和VKA组之间未发现统计学显著差异(RR 0.59;95% CI 0.26 - 1.32;p = 0.204;I = 0%)。全因出血也显著减少(RR 0.33;95% CI 0.19 - 0.57;p = 0.005,I² = 0%)。

结论

本荟萃分析表明,阿哌沙班减少了出血并发症,预防中风效果相当,生存结局相似。这些发现表明,因子Xa抑制剂可能为华法林提供一种更安全、更适合患者的替代方案,特别是在减少胃肠道出血和提高抗凝治疗依从性方面。

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