Visual Abstract Summary for the ARIES-HM3 Trial
Question
Can aspirin be safely excluded from an antithrombotic regimen, including a vitamin K antagonist (VKA), in patients with a fully magnetically levitated LVAD, and does this reduce nonsurgical bleeding complications?
Design
- Trial Type: Randomized, double-blind, placebo-controlled.
- Population: 628 patients with advanced heart failure and fully magnetically levitated LVADs across 51 centers in 9 countries.
- Aspirin group: 314 patients.
- Placebo group: 314 patients.
- Median Follow-up: 14 months.
Key Outcomes
- Primary Endpoint:
- Survival free of major nonsurgical hemocompatibility-related adverse events (stroke, pump thrombosis, major bleeding, or arterial thromboembolism) at 12 months.
- Result: Placebo group: 74% event-free survival vs. Aspirin group: 68%.
- Noninferiority confirmed: (Absolute difference: +6%, 97.5% CI lower bound: −1.6%, P < .001).
- Secondary Endpoint:
- Nonsurgical Bleeding:
- Relative risk reduction: 34% (RR 0.66, 95% CI 0.51–0.85, P = .002).
- No significant increase in thromboembolic events, including stroke or pump thrombosis.
- Nonsurgical Bleeding:
Key Findings
- Avoiding aspirin reduces nonsurgical bleeding without increasing thromboembolic risks.
- Benefits consistent across patient subgroups with vascular disease, obesity, or diabetes.
Conclusion
- Avoiding aspirin is safe and effective in reducing nonsurgical bleeding in patients with fully magnetically levitated LVADs while maintaining thromboembolic safety.
- Aspirin exclusion can significantly improve outcomes in advanced heart failure patients with LVADs.