For the first time, new data shows that an aspirin-free regimen can improve outcomes for people living with a heart pump by reducing hospitalizations without increasing the risk of blood clots, according to the ARIES-HM3 study. The trial was the first international, placebo-controlled randomized study to assess whether the absence of aspirin is safe and decreases bleeding in people with a left ventricular assist device, known as an LVAD, or heart pump, to treat advanced heart failure.
The data were presented during a late-breaking session at the 2023 American Heart Association Scientific Sessions in Philadelphia on Nov. 11 and simultaneously published in The Journal of the American Medical Association.
“These findings can transform how physicians manage the care of these patients and significantly reduce hospitalizations,” said Dr. Nir Uriel, director of advanced heart failure and cardiac transplantation at NewYork-Presbyterian, a co-author and member of the trial steering committee.
While newer advancements in heart pumps are associated with lower rates of complications, bleeding remains one of the leading causes of rehospitalizations. Typically, advanced heart failure patients who receive a heart pump are treated with a blood-thinning regimen to prevent blood clots that includes aspirin and vitamin K antagonist therapy (VKA), which hinders vitamin K’s clotting ability. The study sought to determine whether excluding aspirin as part of the regimen for patients with a newer LVAD is safe and decreases bleeding.
The ARIES-HM3 (Antiplatelet Removal and Hemocompatibility Events With the HeartMate 3 Pump) trial studied more than 600 patients and found that HeartMate 3 (a newer generation device with a magnetically levitated motor that created a frictionless pump) patients who didn’t receive aspirin but continued with VKA spent 47% fewer days in the hospital due to a nearly 40% decrease in bleeding events compared to patients who continued to take aspirin daily.
The study, from July 2020 to September 2022, was conducted across 51 centers and included patients in the United States, Canada, the United Kingdom, France, Italy, Austria, Czech Republic, Kazakhstan, and Australia.
“Thousands of patients with advanced heart failure rely on heart pumps to extend their lives, and we are dedicated to studying ways to improve their quality of life,” said Dr. Uriel, who is also a professor of medicine in the Division of Cardiology at Columbia University Vagelos College of Physicians and Surgeons and an adjunct professor of medicine in the Greenberg Division of Cardiology at Weill Cornell Medicine. “Reducing bleeding can keep people out of the hospital, giving our patients the gift of more time with their loved ones and the opportunity to thrive.”
The paper is titled, “Aspirin and hemocompatibility events with a left ventricular assist device in advanced heart failure.”
The trial was funded by Abbott.
Dr. Uriel is a co-author and trial steering committee member of the study with no financial compensation. He received a research grant from Abbott in connection to a different study.