Clinical Scorecard: Real-World Use and Outcomes of Aspirin Avoidance Following HeartMate 3 Implantation: The PRAISE HM3 Study

At a Glance

Key Highlights

• The overall implementation cohort includes 3,365 patients. Recorded early aspirin use declines from 90.2% in 2023 to 55.7% in 2024 and 52.7% in 2025.

• Among 739 post-ARIES-HM3 recipients, 404 (54.7%) have recorded early aspirin use.

• Aspirin use is more common among patients with prior percutaneous coronary intervention (PCI), coronary artery bypass grafting, stroke, or peripheral vascular disease: 67.1% versus 43.4% without these conditions.

• The 12-month composite of death or first major nonsurgical hemocompatibility-related adverse event occurs in 29.3% with aspirin and 21.7% without recorded aspirin. The adjusted association is not significant (HR for no recorded aspirin versus aspirin, 0.86; 95% CI, 0.61–1.22).

• Major nonsurgical bleeding occurs in 22.0% and 15.0%, respectively, without a significant adjusted association (HR, 0.82; 95% CI, 0.54–1.26).

• No excess stroke or peripheral arterial thromboembolism is observed without recorded aspirin. Pump thrombosis is rare.

Guideline-Based Recommendations

Diagnosis

• This study does not establish diagnostic recommendations. Clinical outcomes are identified using electronic-record algorithms intended to approximate ARIES-HM3 definitions, without patient-level validation against chart-adjudicated events.

Management

• The randomized ARIES-HM3 trial supports aspirin avoidance after de novo HM3 implantation when vitamin K antagonist anticoagulation continues.

• PRAISE HM3 supports distinguishing remote, stable vascular disease from recent vascular events or another active antiplatelet indication. The authors emphasize individualized management after recent PCI, acute coronary syndrome, acute stroke, or another active indication.

Monitoring & Follow-up

• Study follow-up begins at postoperative day 14 among patients alive, supported with the index device, under observation, and free of major nonsurgical hemocompatibility-related adverse events.

• The authors call for continued surveillance for rare thrombotic complications as aspirin avoidance becomes more widely adopted.

Risks

• Major nonsurgical bleeding, particularly gastrointestinal bleeding, remains an important complication after LVAD implantation.

• Nonrandomized treatment selection and residual confounding prevent causal comparisons. Rare thrombotic events and wide confidence intervals preclude conclusions about equivalence or noninferiority.

• Electronic-record outcome ascertainment, unequal follow-up, incomplete event capture, and unavailable timing of prior vascular events limit interpretation.

Patient & Prescribing Data

The contemporary clinical analysis includes 1,577 eligible HM3 recipients: 838 implanted before and 739 after ARIES-HM3 publication. Patients require documented warfarin therapy within 14 days of implantation.

Early aspirin exposure requires a recorded administration, dispense, or active medication order on postoperative days 2–7. Records initiated on days 0–1 also qualify when their documented duration extends into this window. Exposure groups represent initial treatment strategies rather than confirmed long-term adherence or persistence.

Clinical Best Practices

• Distinguish randomized ARIES-HM3 evidence from the observational associations reported in PRAISE HM3.

• A remote vascular diagnosis alone should not compel aspirin continuation during HM3 support with vitamin K antagonist anticoagulation, according to the randomized evidence discussed in the article.

• Interpret the adjusted findings as showing no detected safety signal discordant with ARIES-HM3, rather than proof of equivalent outcomes or a causal benefit from aspirin avoidance.

Related Resources & Content

• Aspirin and hemocompatibility events with a left ventricular assist device in advanced heart failure: The ARIES-HM3 randomized clinical trial — Mehra MR, Netuka I, Uriel N, et al.; JAMA; 2023;330:2171–2181.

• Aspirin and hemocompatibility after LVAD implantation in patients with atherosclerotic vascular disease: A secondary analysis from the ARIES-HM3 randomized clinical trial — Gustafsson F, Uriel N, Netuka I, et al.; JAMA Cardiology; 2025;10:235–242.

• Impact of atrial fibrillation, diabetes mellitus, and obesity on outcomes with aspirin avoidance and hemocompatibility with a left ventricular assist device: An analysis from the ARIES-HM3 trial — Uriel N, Netuka I, Jorde UP, et al.; Journal of Cardiac Failure; 2026;32:1224–1233.

• Withdrawal of aspirin in patients with left ventricular assist device treated with vitamin K antagonists: Impact of anticoagulation quality in the randomized ARIES-HM3 trial — Connors JM, Gustafsson F, Uriel N, et al.; European Heart Journal; 2026;47:942–952.

• Concomitant surgical procedures and aspirin avoidance with left ventricular assist device therapy — Pagani FD, Netuka I, Jorde UP, et al.; JACC: Heart Failure; 2025;13:102411.

• Hemocompatibility outcomes with pharmacological therapy following LVAD implantation: Insights from the ARIES-HM3 trial — Katz JN, Connors JM, Pagani FD, et al.; JACC: Heart Failure; 2026;14:102769.