Aspirin Discontinuation in Patients With HeartMate3 LVADs

The American Heart Association’s Scientific Sessions 2023 took place November 10-13 in Philadelphia, Pennsylvania. Among the multiple featured late-breaking trials, the findings of ARIES-HM3, presented by Dr. Mandeep Mehra, represent a monumental step forward in the care of patients with advanced heart failure. The trial answers this question: Can aspirin be safely avoided in patients with a HeartMate3 left ventricular assist device (LVAD) who are taking vitamin K antagonists (VKA)?

In 2019, MOMENTUM 3 showed that the magnetically levitated HeartMate3 (HM3) LVAD had superior hemocompatibility compared with the HeartMate2 LVAD, with extremely low rates of pump thrombosis and a significant reduction in rates of stroke. Bleeding events were also lower, although all-cause bleeding still remained a leading cause of morbidity in HM3. Minimization of bleeding represented a main avenue for risk reduction in patients with HM3 LVADs, hence the genesis of the ARIES-HM3 trial.

This international, double-blind, placebo-controlled study randomized 628 patients implanted with an HM3 LVAD on VKA therapy with an international normalized ratio for atrial fibrillation goal of 2 to 3 to placebo versus aspirin 100 mg daily. The composite primary end point was survival free of a major hemocompatibility event (stroke, pump thrombosis, major bleeding, or arterial peripheral thromboembolism) at 12 months postimplant, assessed for noninferiority.

More patients in the placebo group reached the primary end point (74%) versus those in the aspirin group (68%). Aspirin discontinuation was found to be safe and met the noninferiority criteria. The difference between groups was driven by reduced bleeding in the placebo group, with 14.5 major bleeding events averted per 100 patients avoiding aspirin. Importantly, the omission of aspirin did not lead to an increase in thrombotic events. Investigators concluded that aspirin is not required to preserve hemocompatibility in patients with HM3 LVADs and can be safely excluded.

This study represents the first trial evaluating medical therapy in patients with LVADs and signifies a major advancement in improving the morbidity and quality of life in this patient population.

Dr. Christian Inchaustegui is a Cardiology Fellow at the Oregon Health & Science University and served as a CardioNerds Conference Scholar for the American Heart Association’s Scientific Sessions 2023.

References

1. Mehra MR, Uriel N, Naka Y, et al; MOMENTUM 3 Investigators. A fully magnetically levitated left ventricular assist device – final report. N Engl J Med. 2019;380(17):1618-1627. doi:10.1056/NEJMoa1900486
2. Mehra MR, Netuka I, Uriel N, et al. Aspirin and hemocompatibility events with a left ventricular assist device in advanced heart failure: the ARIES-HM3 randomized clinical trial. 2023. doi:10.1001/jama.2023.23204