Concomitant Surgical Procedures and Aspirin Avoidance With Left Ventricular Assist Device Therapy.

Area of Science:

• Cardiovascular Surgery
• Medical Devices
• Clinical Trials

Background:

• The ARIES-HM3 trial showed aspirin avoidance with HeartMate 3 (HM3) left ventricular assist device (LVAD) reduces bleeding without increasing thromboembolism.
• The impact of concomitant surgical procedures on these outcomes was previously uncertain.

Purpose of the Study:

• To assess clinical outcomes of aspirin avoidance in HM3 LVAD patients who underwent concomitant surgical procedures.
• To evaluate the safety and efficacy of excluding aspirin while maintaining a vitamin K antagonist during LVAD implantation with concurrent surgeries.

Main Methods:

• A prespecified analysis of the ARIES-HM3 trial involving 628 patients randomized to placebo or aspirin with a vitamin K antagonist.
• Patients were sub-categorized based on whether they underwent concomitant surgical procedures (valvular/CABG or non-valvular).
• The primary endpoint was survival free from major nonsurgical hemocompatibility-related adverse events at 12 months.

Main Results:

• No significant interaction was observed between concomitant procedures and primary outcomes (P_int > 0.05 for all categories).
• A similar reduction in nonsurgical major hemorrhagic events was observed with placebo versus aspirin in patients with or without concomitant procedures.
• The percentage of subjects achieving primary endpoint success was higher in the placebo group among those with concomitant procedures.

Conclusions:

• Aspirin avoidance is safe and effective in HM3 LVAD patients, even when undergoing concomitant surgical procedures.
• This antithrombotic strategy supports reduced bleeding complications without compromising safety.
• Findings support the exclusion of aspirin in the antithrombotic regimen for HM3 LVAD patients with concurrent surgeries.