- A study published in the Journal of Cardiac Failure used Truveta Data to track aspirin use after HeartMate 3 implantation following new trial evidence.
- Researchers benchmarked outcome measures against a national registry and captured aspirin from hospital doses, dispenses, and orders.
- Aspirin use fell from 90.2% in 2023 to 52.7% in 2025 but persisted most often in patients with vascular disease.
- Avoiding aspirin was not associated with a higher adjusted risk of death or major complications.
Bleeding remains an important cause of complications and hospital stays for people with advanced heart failure who receive a left ventricular assist device (LVAD), and for years, most patients took aspirin along with the anticoagulant warfarin. In 2023, the ARIES-HM3 trial found that aspirin could be safely omitted for patients with the HeartMate 3 LVAD who continued warfarin, and the FDA updated the device label the following year.
In a study published in the Journal of Cardiac Failure, researchers from US health systems, academic medical centers, and Abbott (the maker of HeartMate 3) examined how quickly that evidence reached practice and whether real-world outcomes were consistent with the trial.
Study snapshot
Researchers identified 3,365 adults in Truveta Data who received an LVAD and were treated with warfarin between 2016 and 2026, and tracked aspirin use before and after the trial and label change. To compare outcomes, they followed 739 patients who received a HeartMate 3 after the trial was published, tracking death and major complications such as bleeding, stroke, and clotting over 12 months.
Building confidence in real-world outcomes
In clinical trials, a committee of experts reviews each bleeding or stroke event. Because of the scale needed to assess the impact of the guideline change, researchers built event definitions using real-world electronic health record data to match the trial as closely as possible, combining diagnosis codes with hospital visits, blood transfusions, and lab results documented in routine care. They then benchmarked these definitions against the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS), a national registry of patients with heart pumps, comparing one-year rates of death, gastrointestinal bleeding, stroke, and pump thrombosis with those of nearly 9,000 registry patients over the same period. Aspirin use was captured in similar detail, from doses given in the hospital, dispensed, or ordered in the first week after surgery.
Aspirin use fell, but persisted for patients with vascular disease
After the trial published in late 2023, recorded aspirin use fell from 90.2% of patients that year to 52.7% in 2025, and the decline was sustained after the FDA label change. Clinicians were more likely to continue aspirin for patients with a history of stroke, peripheral vascular disease, or a procedure to open or bypass blocked heart arteries (67.1%) than for patients without these conditions (43.4%). Vascular disease has long been a reason to prescribe aspirin, but an analysis of the trial found that avoiding aspirin was also safe for these patients, who appeared to have an even larger reduction in bleeding. The authors noted that some continued use may reflect individual decisions, such as after a recent heart procedure.
Outcomes without aspirin were consistent with the trial
Avoiding aspirin was not associated with a higher risk of death or major complications. Patients managed without aspirin had fewer of these events within 12 months (21.7% compared with 29.3%), but they were also younger and less likely to have vascular disease, diabetes, and other risk factors. After researchers accounted for these differences, the gap was no longer statistically significant. Stroke and blood clots in the arteries were not more common without aspirin, and pump thrombosis was rare.
Because the study was observational, the authors describe the findings as early real-world safety monitoring rather than evidence that avoiding aspirin directly improved outcomes. As they note, health record data from many health systems can show changes in clinical practice quickly and track safety across a broader range of patients than trials typically enroll.
Read the full study
Real-World Adoption and Associated Outcomes of Aspirin Avoidance After HeartMate 3 Implantation: The PRAISE HM3 Study, Journal of Cardiac Failure
