ARIES-HM3 (secondary analysis)
Trial question
Is avoidance of aspirin noninferior to aspirin in patients with advanced HF treated with a fully magnetically levitated LV assist device, with or without atherosclerotic vascular disease?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
23.0% female
77.0% male
N = 589
589 patients (133 female, 456 male).
Inclusion criteria: patients with advanced HF treated with a fully magnetically levitated LV assist device [HeartMate 3™], with or without atherosclerotic vascular disease.
Key exclusion criteria: post-implant additional temporary or permanent mechanical circulatory support; investigator mandated antiplatelet therapy for other conditions; patients who were NPO post-implant through day 7; known allergy to aspirin.
Interventions
N=271 aspirin avoidance (placebo plus VKA therapy).
N=273 aspirin therapy (aspirin 100 mg/day plus VKA therapy).
Primary outcome
Survival free of any nonsurgical hemocompatibility-related adverse events in patients with a history of atherosclerotic vascular disease
73.6%
61.4%
73.6 %
55.2 %
36.8 %
18.4 %
0.0 %
Aspirin
avoidance
Aspirin
therapy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in survival free of any nonsurgical hemocompatibility-related adverse events in patients with a history of atherosclerotic vascular disease (73.6% vs. 61.4%; AD 12.2%, 95% CI -0.1 to 24.4).
Secondary outcomes
No significant difference in survival free of any nonsurgical hemocompatibility-related adverse events in patients without a history of atherosclerotic vascular disease (74.7% vs. 72.1%; AD 2.6%, 95% CI -7.2 to 12.4).
No significant difference in thrombotic events during follow-up in patients with a history of atherosclerotic vascular disease (0.02 events / p-ys vs. 0.041 events / p-ys; RR 0.48, 95% CI 0.11 to 2).
No significant difference in thrombotic events during follow-up in patients without a history of atherosclerotic vascular disease (0.014 events / p-ys vs. 0.022 events / p-ys; RR 0.64, 95% CI 0.15 to 2.7).
Conclusion
In patients with advanced HF treated with a fully magnetically levitated LV assist device [HeartMate 3™], with or without atherosclerotic vascular disease, aspirin avoidance was noninferior to aspirin therapy with respect to survival free of any nonsurgical hemocompatibility-related adverse events in patients with a history of atherosclerotic vascular disease.
Reference
Finn Gustafsson, Nir Uriel, Ivan Netuka 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 Mar 1;10(3):235-242.
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