ARIES-HM3 (original research)
Trial question
Is avoidance of aspirin noninferior to aspirin in patients with advanced HF treated with a fully magnetically levitated LV assist device?
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™].
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=314 aspirin avoidance (placebo added to the antithrombotic regimen and VKA therapy).
N=314 aspirin therapy (aspirin 100 mg/day added to the antithrombotic regimen and VKA therapy).
Primary outcome
Survival free of a major nonsurgical hemocompatibility-related adverse events at 12 months
74.2%
68.1%
74.2 %
55.7 %
37.1 %
18.6 %
0.0 %
Aspirin
avoidance
Aspirin
therapy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in survival free of a major nonsurgical hemocompatibility-related adverse events at 12 months (74.2% vs. 68.1%; AD 6%, 95% CI -1.6 to 13.7).
Secondary outcomes
Significant decrease in the incidence of nonsurgical bleeding events (25.9/100 py vs. 39.5/100 py; RR 0.66, 95% CI 0.51 to 0.85).
Significant decrease in the incidence of moderate or severe gastrointestinal bleeding events (13.1/100 py vs. 21.6/100 py; RR 0.61, 95% CI 0.42 to 0.87).
No significant difference in the incidence of hemorrhagic stroke events (0.3/100 py vs. 0.9/100 py; RR 0.32, 95% CI 0.03 to 3.08).
Safety outcomes
No significant difference in stroke and other thromboembolic events.
Conclusion
In patients with advanced HF treated with a fully magnetically levitated LV assist device [HeartMate 3™], aspirin avoidance was noninferior to aspirin therapy with respect to survival free of a major nonsurgical hemocompatibility-related adverse events at 12 months.
Reference
Mandeep R Mehra, Ivan Netuka, Nir Uriel et al. Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure: The ARIES-HM3 Randomized Clinical Trial. JAMA. 2023 Dec 12;330(22):2171-2181.
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