Real World Adoption and Associated Outcomes of Aspirin Avoidance After HeartMate 3 Implantation: The PRAISE HM3 Study.

BACKGROUND

The ARIES-HM3 trial demonstrated that aspirin can be safely omitted after HeartMate 3 (HM3) implantation when vitamin K antagonist anticoagulation is continued, resulting in reduced nonsurgical bleeding without an increased risk of thromboembolic events. The pace, extent, and pattern of adoption in clinical practice, and whether real-world outcomes after adoption are consistent with the trial, remain uncertain.

METHODS

Using the Truveta electronic health record network (30 U.S. health systems), we identified adults undergoing de novo durable left ventricular assist device (LVAD) implantation with documented warfarin therapy from January 2016 through March 2026. Recorded early aspirin use was defined as an aspirin administration, dispense, or active order on postoperative days 2-7. Temporal trends were examined relative to ARIES-HM3 publication (November 2023) and the FDA labeling revision (August 2024). Among HM3 recipients implanted after ARIES-HM3 publication and event-free at a postoperative day-14 landmark, the 12-month composite of death or first major nonsurgical hemocompatibility-related adverse event (HRAE) was compared using Kaplan-Meier methods and sequentially adjusted Cox regression.

RESULTS

In the overall LVAD cohort (n=3,365), recorded aspirin use declined from 90.2% in 2023 to 55.7% in 2024 and 52.7% in 2025. Of 739 post-ARIES HM3 recipients, 404 (54.7%) had recorded early aspirin use. Aspirin was continued in 67.1% of patients with prior PCI, CABG, stroke, or peripheral vascular disease versus 43.4% of those without. The 12-month composite occurred in 29.3% of patients with and 21.7% without recorded aspirin (unadjusted HR, 0.70; 95% CI, 0.51-0.94); after multivariable adjustment, no significant association remained (HR, 0.86; 95% CI, 0.61-1.22). Major nonsurgical bleeding occurred in 22.0% and 15.0%, respectively (unadjusted HR, 0.65; 95% CI, 0.45-0.94; adjusted HR, 0.82; 95% CI, 0.54-1.26). Stroke (4.7% vs 2.7%) and peripheral arterial thromboembolism (4.3% vs 2.6%) were not more frequent without aspirin; pump thrombosis was rare (2 vs 3 events).

CONCLUSIONS

After ARIES-HM3 publication and the FDA labeling revision, aspirin use in HM3 LVAD implantation declined substantially but persisted in approximately half of recipients, most often in those with established vascular disease, the population in which ARIES-HM3 showed preserved safety and a numerically greater bleeding reduction with aspirin avoidance. In this observational analysis, aspirin avoidance was not associated with a higher adjusted risk of the composite outcome, and no excess of stroke or arterial thromboembolism was observed.