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Published on: June 12, 2021
Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure: The ARIES-HM3
Mandeep R Mehra1, Ivan Netuka2, Nir Uriel3
1Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Insights
Avoiding aspirin with left ventricular assist devices (LVADs) in heart failure patients is safe and reduces bleeding. This approach, combined with VKA therapy, shows noninferiority to aspirin use and lowers nonsurgical bleeding events.
Area of Science:
- Cardiology
- Medical Devices
- Pharmacology
Background:
- Left ventricular assist devices (LVADs) improve outcomes in advanced heart failure.
- Nonsurgical bleeding is a significant complication in LVAD patients.
- Current guidelines often mandate aspirin with VKA therapy, despite limited evidence.
Purpose of the Study:
- To evaluate the safety and efficacy of excluding aspirin from antithrombotic regimens in patients with fully magnetically levitated LVADs.
- To determine if aspirin avoidance reduces bleeding events without increasing thromboembolic risk.
Main Methods:
- International, randomized, double-blind, placebo-controlled trial involving 628 patients with fully magnetically levitated LVADs.
- Patients received VKA therapy plus either aspirin (100 mg/d) or placebo.
- Primary endpoint: 12-month survival free of hemocompatibility-related adverse events (stroke, pump thrombosis, major bleeding, thromboembolism).
Main Results:
- Placebo group showed noninferiority in event-free survival (74% vs 68% in aspirin group).
- Aspirin avoidance significantly reduced nonsurgical bleeding events (RR 0.66; P=.002).
- No increase in stroke or other thromboembolic events observed with aspirin avoidance.
Conclusions:
- Excluding aspirin from VKA therapy in LVAD patients is safe and effective.
- Aspirin avoidance reduces bleeding complications without compromising thrombotic protection.
- This finding supports revised antithrombotic strategies for LVAD recipients.
Importance:
Left ventricular assist devices (LVADs) enhance quality and duration of life in advanced heart failure. The burden of nonsurgical bleeding events is a leading morbidity. Aspirin as an antiplatelet agent is mandated along with vitamin K antagonists (VKAs) with continuous-flow LVADs without conclusive evidence of efficacy and safety.
Objective:
To determine whether excluding aspirin as part of the antithrombotic regimen with a fully magnetically levitated LVAD is safe and decreases bleeding.
Design, Setting, And Participants:
This international, randomized, double-blind, placebo-controlled study of aspirin (100 mg/d) vs placebo with VKA therapy in patients with advanced heart failure with an LVAD was conducted across 51 centers with expertise in treating patients with advanced heart failure across 9 countries. The randomized population included 628 patients with advanced heart failure implanted with a fully magnetically levitated LVAD (314 in the placebo group and 314 in the aspirin group), of whom 296 patients in the placebo group and 293 in the aspirin group were in the primary analysis population, which informed the primary end point analysis. The study enrolled patients from July 2020 to September 2022; median follow-up was 14 months.
Intervention:
Patients were randomized in a 1:1 ratio to receive aspirin (100 mg/d) or placebo in addition to an antithrombotic regimen.
Main Outcomes And Measures:
The composite primary end point, assessed for noninferiority (-10% margin) of placebo, was survival free of a major nonsurgical (>14 days after implant) hemocompatibility-related adverse events (including stroke, pump thrombosis, major bleeding, or arterial peripheral thromboembolism) at 12 months. The principal secondary end point was nonsurgical bleeding events.
Results:
Of the 589 analyzed patients, 77% were men; one-third were Black and 61% were White. More patients were alive and free of hemocompatibility events at 12 months in the placebo group (74%) vs those taking aspirin (68%). Noninferiority of placebo was demonstrated (absolute between-group difference, 6.0% improvement in event-free survival with placebo [lower 1-sided 97.5% CI, -1.6%]; P < .001). Aspirin avoidance was associated with reduced nonsurgical bleeding events (relative risk, 0.66 [95% confidence limit, 0.51-0.85]; P = .002) with no increase in stroke or other thromboembolic events, a finding consistent among diverse subgroups of patient characteristics.
Conclusions And Relevance:
In patients with advanced heart failure treated with a fully magnetically levitated LVAD, avoidance of aspirin as part of an antithrombotic regimen, which includes VKA, is not inferior to a regimen containing aspirin, does not increase thromboembolism risk, and is associated with a reduction in bleeding events.
Trial Registration:
ClinicalTrials.gov Identifier: NCT04069156.
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