Andrea Tripoli, Miguel A Samaniego, Norma N Gamarra-Valverde, Shivraj Paneer Selvam, Edgardo Kaplinsky, Alejandro Barbagelata, Anna Mara Scandroglio, Juliana Giorgi
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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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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<sup>²</sup>=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<sup>²</sup>=0%). All-cause bleeding was also significantly reduced (RR 0.33; 95% CI 0.19-0.57; p = 0.005, I²=0%).</p><p><strong>Conclusions: </strong>This meta-analysis showed that Apixaban reduced bleeding complications, comparable stroke prevention, and similar survival outcomes. 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引用次数: 0
摘要
背景:维生素K拮抗剂(VKAs)是左心室辅助装置(lvad)患者抗凝治疗的一线策略。最近,HeartMate 3 (HM3) LVAD显示出比以前的技术更低的血栓并发症。直接口服抗凝剂(DOACs)正在成为该患者群体口服抗凝的替代方案。然而,它们的安全性和有效性仍不确定。由于doac代表了具有不同特征的药物类别,本荟萃分析将研究直接因子Xa抑制剂阿哌沙班对HM3-LVAD的影响。方法:我们系统地检索医学数据库,比较阿哌沙班和vka在HM3支持患者中的应用。主要终点是血液相容性相关不良事件(HRAEs)和大出血。全因死亡率、轻度出血、全出血、血栓栓塞事件和中风作为次要结局进行分析。结果:纳入5项研究,共209例患者(阿哌沙班治疗119例,vka治疗90例)。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;²= 0%)。阿哌沙班组与VKA组在HRAEs主要疗效终点分析上无统计学差异(RR 0.59;95% ci 0.26-1.32;p = 0.204;²= 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:该荟萃分析显示阿哌沙班减少了出血并发症,卒中预防和相似的生存结果。这些发现表明,Xa因子抑制剂可能是华法林的一种更安全、对患者更友好的替代品,特别是在减少胃肠道出血和提高抗凝治疗依从性方面。
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.
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; I²=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; I²=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.
期刊介绍:
The Journal of Thrombosis and Thrombolysis is a long-awaited resource for contemporary cardiologists, hematologists, vascular medicine specialists and clinician-scientists actively involved in treatment decisions and clinical investigation of thrombotic disorders involving the cardiovascular and cerebrovascular systems. The principal focus of the Journal centers on the pathobiology of thrombosis and vascular disorders and the use of anticoagulants, platelet antagonists, cell-based therapies and interventions in scientific investigation, clinical-translational research and patient care.
The Journal will publish original work which emphasizes the interface between fundamental scientific principles and clinical investigation, stimulating an interdisciplinary and scholarly dialogue in thrombosis and vascular science. Published works will also define platforms for translational research, drug development, clinical trials and patient-directed applications. The Journal of Thrombosis and Thrombolysis'' integrated format will expand the reader''s knowledge base and provide important insights for both the investigation and direct clinical application of the most rapidly growing fields in medicine-thrombosis and vascular science.