PRAISE-HM3 Real-World Data Show Decline in Aspirin Use After HeartMate 3 Implantation
New findings presented at HFSA 2026 examine changes in antithrombotic management following ARIES-HM3 and the HeartMate 3 FDA labeling update
New findings presented at HFSA 2026 examine changes in antithrombotic management following ARIES-HM3 and the HeartMate 3 FDA labeling update
Abbott announced new real-world data from the PRAISE-HM3 study examining antithrombotic management among patients supported by the HeartMate 3 left ventricular assist device (LVAD). The findings were presented at HFSA 2026 and simultaneously published in the Journal of Cardiac Failure.
The study evaluated how clinical practice has changed following publication of the ARIES-HM3 trial and the subsequent FDA labeling update for HeartMate 3. Recorded aspirin use declined from 90.2% in 2023 to 52.7% in 2025.
Overall, PRAISE-HM3 found no significant difference in the primary composite outcome of death or first major nonsurgical hemocompatibility-related adverse event between patients with and without recorded early aspirin use.
Major nonsurgical bleeding occurred in 15.0% of patients managed without aspirin compared with 22.0% of patients receiving aspirin, although the difference was not statistically significant after adjustment. Stroke rates remained low in both groups, occurring in 2.7% of patients without aspirin and 4.7% of those receiving aspirin.
Aspirin use remained more common among patients with a history of vascular disease, at 67.1%, compared with 43.4% among those without a history of vascular disease. Despite the overall decline in aspirin use, more than half of HeartMate 3 patients continued to receive aspirin.
“The study highlights an important potential for further improvement in post-LVAD antithrombotic management as more than 50% of patients still receive aspirin after the release of the FDA labelling revision,” said Finn Gustafsson, MD, PhD, chief medical officer and divisional vice president of Abbott’s heart failure business. “PRAISE-HM3 adds useful real-world evidence as we continue to refine antithrombotic management after HeartMate 3 implantation.”
The findings provide real-world evidence on changes in antithrombotic practice following publication of ARIES-HM3 and the HeartMate 3 labeling update.
Reference
Sheikh FH, Molina EJ, Jorde UP, Byku MP, Kim JA, Bettampadi D, Gustafsson F, Mehra MR. Real World Adoption and Associated Outcomes of Aspirin Avoidance After HeartMate 3 Implantation: The PRAISE HM3 Study. J Card Fail. 2026 Oct 12:S1071-9164(26)00596-8. doi: 10.1016/j.cardfail.2026.09.031
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CLD talks with Igor Gosev, MD, PhD, Chief, Heart Transplant and Mechanical Circulatory Support (MCS), Newark Beth Israel Medical Center, RWJBarnabas Health, Newark, New Jersey
