Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure: The ARIES-HM3...

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.