Aspirin Avoidance Safe Without Increased Thrombosis Risk in LVAD Patients: JAMA
The ARIES-HM3 trial analysis found that in advanced heart failure patients with traditional indications for antiplatelet therapy at the time of left ventricular assist device (LVAD) implantation, avoiding aspirin was safe and did not increase the risk of thrombosis. The ARIES-HM3 study examines the safety and efficacy of aspirin avoidance in patients with preexisting conditions such as prior percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), stroke, or peripheral vascular disease (PVD). This study was published in the journal of JAMA Cardiology by Finn G. and colleagues.
A total of 51 centers participated in the international, multicenter, prospective, double-blind, placebo-controlled, randomized clinical trial, ARIES-HM3. Data analysis was conducted between April and July 2024. Patients who received a de novo HM3 LVAD were randomized 1:1 to aspirin 100 mg/day or placebo with a vitamin K antagonist (VKA) to achieve an international normalized ratio (INR) of 2 to 3.
A total of 589 patients were included in the study, with a mean age of 57.1 years and 77.4% male. Among them, 240 patients (41%) had a history of PCI, CABG, stroke, or PVD. The primary endpoint was a composite of survival free of nonsurgical HRAEs, including stroke, pump thrombosis, bleeding, and arterial thromboembolism, at 12 months. Secondary endpoints assessed individual complications, such as nonsurgical bleeding, stroke, and pump thrombosis.
Key Findings
• The analysis demonstrated no meaningful interaction between the presence of vascular conditions and the effect of aspirin compared with placebo (p=0.23).
• The prespecified 10% non inferiority margin was not crossed in the presence of vascular conditions, suggesting that aspirin avoidance was safe.
• Thrombotic events were few in all the groups, without significant differences in aspirin treatment versus placebo irrespective of vascular disease status (p=0.77).
• A higher rate of nonsurgical major bleeding events occurred in patients who had a history of vascular conditions; the rate ratio for placebo relative to aspirin was 0.52 (95% CI, 0.35-0.79).
• For patients without vascular conditions, the difference in bleeding risk was not as pronounced, reinforcing the safety of aspirin avoidance in this population.
A safer aspirin-free strategy was used in patients with advanced heart failure, indicating that it doesn't increase thrombosis rates. It also reduced nonsurgical bleeding events particularly in patients that had prior conditions such as a history of PVD, CABG, stroke, or even PCI. These findings may guide a shift in the management of antithrombotic therapy in LVAD patients, emphasizing a tailored approach based on individual risk factors.
Reference:
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
