Eliminating Aspirin Safe After LVAD Implantation in Advanced Heart Failure

Mandeep R. Mehra, MD, MSc

Credit: Brigham and Women's Hospital

A prespecified analysis of the ARIES-HM3 randomized clinical trial found aspirin avoidance safe and not linked to an elevated thrombosis risk in patients with advanced heart failure after left ventricular assist device (LVAD) implantation.¹

History of common atherosclerotic vascular conditions requiring aspirin, including prior percutaneous coronary intervention (PCI, coronary artery bypass grafting (CABG), stroke, or peripheral vascular disease (PVD), did not influence the benefit of aspirin avoidance on hemocompatibility-related adverse events (HRAEs) in the trial.

“This subanalysis from the ARIES-HM3 trial has provided reassurance that aspirin omission is safe even in patients with a history of remote PCI, CABG, stroke, or PVD undergoing HeartMate 3 (HM3) LVAD implantation,” wrote the investigative team, led by Mandeep R. Mehra, MD, MSc, medical director of the Brigham and Women's Hospital (BWH) Heart and Vascular Center. “However, these findings may be specific to the HM3 LVAD and not generalizable to other durable LVAD technologies.”

Aspirin is commonly recommended for secondary prevention in various acute and chronic cardiovascular conditions—in patients with heart failure, atherosclerotic comorbidities are common, with nearly 50% receiving aspirin.² Key findings from the ARIES-HM3 trial reported aspirin could be removed after HM3 LVAD implantation, with a vitamin K antagonist (VKA) alone resulting in fewer nonsurgical bleeding events.³

ARIES was conducted in 51 centers globally, comparing placebo or aspirin and VKA therapy in those with advanced heart failure receiving the HM3 device. For this secondary trial-level analysis, Mehra and colleagues assessed how aspirin avoidance in patients with a history of common atherosclerotic vascular conditions, including CABG, PCI, stroke, or PVD, would influence HRAEs post-LVAD implantation.¹

The analysis’ primary endpoint was a composite of survival-free of non-surgical HRAEs, including stroke, pump thrombosis, bleeding, and arterial peripheral thromboembolism at 12 months. Those with endpoint events occurring within 14 days after LVAD implantation were excluded from the analysis. Secondary endpoints included non-surgical bleeding, stroke, and pump thrombosis events.

ARIES enrolled 878 patients and randomized 628 into the analysis—of the randomized patients, 39 were excluded owing to the above criteria, leaving 589 patients (mean age, 57.1 years; 456 male [77.4%]) for the primary endpoint analysis. A historic of atherosclerotic vascular conditions was identified in 240 individuals (41%), with prior PCI marking the most common condition.

Upon analysis, Mehra and colleagues found no interaction between the presence of any atherosclerotic vascular condition and the effect of aspirin, compared with placebo (P for interaction = .23). Notably, the preset 10% noninferiority margin was not crossed for the subgroups with a history of PCI, CABG, stroke, or PVD.

Further analysis demonstrated the rarity of thrombotic events, without an indication of the difference between aspirin and placebo in patients with or without vascular disease (P for interaction = .77). Overall cumulative incidence of nonsurgical major bleeding events was increased in those with a history of PCI, CABG, stroke, or PVD, compared with those without a history of vascular disease.

Mehra and colleagues attributed the increased rate of bleeding events in those with vascular event history to aspirin randomization (rate ratio [RR], 0.52; 95% CI, 0.35–0.79). On the other hand, the difference in bleeding between aspirin and placebo was reduced for those without a vascular event history (RR, 0.76; 95% CI, 0.54–1.06).

Survival free from death and nonsurgical HRAE analysis demonstrated a significant reduction in risk at 24 months between aspirin and placebo for patients with a prior indication for aspirin (hazard ratio [HR], 0.63; 95% CI, 0.41-0.98; P = .04), but not those without an indication.

“Thus, the presence of these clinical conditions should not compel physicians to use aspirin as part of the antithrombotic regimen after LVAD implantation with the fully magnetically levitated HM3 LVAD,” Mehra and colleagues added.

References

1. _{Gustafsson F, Uriel N, Netuka I, 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. Published online January 08, 2025. doi:10.1001/jamacardio.2024.4849}
2. _{Madelaire C, Gislason G, Kristensen SL, et al. Low-Dose Aspirin in Heart Failure Not Complicated by Atrial Fibrillation: A Nationwide Propensity-Matched Study. JACC Heart Fail. 2018;6(2):156-167. doi:10.1016/j.jchf.2017.09.021}
3. _{Mehra MR, Netuka I, Uriel N, et al. Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure: The ARIES-HM3 Randomized Clinical Trial. JAMA. 2023;330(22):2171-2181. doi:10.1001/jama.2023.23204}