Key result
VKA monotherapy significantly reduced hemocompatibility-related adverse events compared to VKA and aspirin in HeartMate 3 patients (OR 0.11; 95% CI 0.02-0.59; p=0.01).
Why the study?
Bleeding complications due to combined VKA and aspirin therapy remain high in HeartMate 3 patients, but safety data on VKA monotherapy are limited.
Does vitamin K antagonist monotherapy reduce hemocompatibility-related adverse events in patients with HeartMate 3 left ventricular assist devices compared to combined therapy with VKA and aspirin?
Meta-Analysis (n=785)
Does vitamin K antagonist monotherapy reduce hemocompatibility-related adverse events in patients with HeartMate 3 left ventricular assist devices compared to combined therapy with VKA and aspirin?
Odds Ratio: 0.11 (95% CI 0.02–0.59)
p-value: p=0.01
In patients with HeartMate 3 left ventricular assist devices, omitting aspirin and using VKA monotherapy significantly reduces bleeding events without increasing the risk of thromboembolic complications.
The HeartMate 3 (HM3) left ventricular assist device has decreased thromboembolic events and minimized the risk of pump thrombosis. However, bleeding complications due to combined antithrombotic therapy with a vitamin K antagonist (VKA) and aspirin remain high. Only limited data on the safety of VKA monotherapy in HM3 patients are available. A systematic search on the main databases was performed. Observational data and randomized trials were eligible for this analysis. As primary endpoint, we analyzed hemocompatibility-related adverse events (HRAE). As secondary endpoints, we investigated the individual components of the primary endpoint. The analysis was carried out using the odds ratio (OR) as outcome measure. A random-effects model was fitted to the data. Five manuscripts fulfilled the inclusion criteria. These trials included 785 patients (381 on VKA monotherapy, 404 on VKA and aspirin). VKA monotherapy significantly reduced HRAE (OR: 0.11 [95% confidence interval {CI}: 0.02-0.59], p = 0.01, I2 = 87%). The reduction was driven by a decrease in bleeding complications (OR: 0.12 [95% CI: 0.02-0.62], p = 0.01, I2 = 86%) without increasing the rates of thromboembolic events (OR: 0.69 [95% CI: 0.26-1.81], p = 0.45, I = 0%). Vitamin K antagonist monotherapy is associated with a significant reduction of bleeding events without increasing the risk of thromboembolic complications in HM3 patients.
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Tscharre et al. (2024) conducted a meta-analysis in HeartMate 3 left ventricular assist devices (n=785). VKA monotherapy vs. VKA and aspirin was evaluated on hemocompatibility-related adverse events (HRAE) (OR 0.11, 95% CI 0.02-0.59, p=0.01). VKA monotherapy significantly reduced hemocompatibility-related adverse events compared to VKA and aspirin in HeartMate 3 patients (OR 0.11; 95% CI 0.02-0.59; p=0.01).
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