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.

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^²=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^²=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.