ARIES-HM3
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
Key exclusion criteria: post-implant additional temporary or permanent mechanical circulatory support; investigator mandated antiplatelet therapy for other conditions; patients who are NPO post-implant through day 7; known allergy to acetylsalicylic acid
Interventions
N=314 placebo (matching placebo added to antithrombotic regimen and VKA therapy)
N=314 aspirin (aspirin 100 mg/day added to 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 %
Placebo
Aspirin
Difference not exceeding
nonferiority margin ✓
Difference not exceeding nonferiority 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, placebo was noninferior to aspirin 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 Nov 11.
Open reference URL