IN PATIENTS with advanced heart failure and an implanted HeartMate 3 (HM3) left ventricular assist device (LVAD), aspirin avoidance was found to be safe, with no increased risk of thrombosis and a significant reduction in nonsurgical bleeding, even in those with prior vascular conditions traditionally requiring aspirin therapy.
This secondary analysis of the ARIES-HM3 randomized clinical trial evaluated whether conditions such as prior percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), stroke, or peripheral vascular disease (PVD) modified the outcomes when aspirin was excluded from the antithrombotic regimen. The study involved 589 patients across 51 centers, randomized in a double-blind, placebo-controlled design to receive either aspirin (100 mg daily) or placebo alongside a vitamin K antagonist. The primary endpoint was survival free of nonsurgical hemocompatibility-related adverse events (HRAEs) at 12 months, including stroke, pump thrombosis, bleeding, or arterial peripheral thromboembolism.
Of the patients analyzed, 41% had a history of vascular conditions. The results demonstrated no significant interaction between the presence of these conditions and aspirin’s effects compared to placebo (P for interaction = .23). Thrombotic events were rare, and there were no significant differences between aspirin and placebo in patients with or without vascular disease (P for interaction = .77). However, aspirin use was linked to a higher rate of nonsurgical bleeding in patients with a vascular history, with the rate ratio favoring placebo at 0.52 (95% CI, 0.35–0.79). The noninferiority margin for the primary endpoint was not crossed, indicating that aspirin avoidance was not associated with worse outcomes in the studied subgroup.
In conclusion, the findings suggest that aspirin can be safely eliminated from the antithrombotic regimen in patients with HM3 LVADs, including those with atherosclerotic vascular conditions. This approach reduces nonsurgical bleeding risk without compromising thrombotic safety, providing a meaningful shift in clinical practice. Future research may explore the implications of these findings for broader antithrombotic management in advanced heart failure patients.
Katrina Thornber, EMJ
Reference
Gustafsson F et al. Aspirin and hemocompatibility after LVAD Implantation in patients with atherosclerotic vascular disease: a secondary analysis from the aries-hm3 randomized clinical trial. JAMA Cardiol. 2025;DOI:10.1001/jamacardio.2024.4849.
