Abbott’s HeartMate 3 LVAD Studied With Aspirin-Free Antiplatelet Regimen in ARIES

November 27, 2023—Abbott recently announced data showing that advanced heart failure patients living with the company’s HeartMate 3 left ventricular assist device (LVAD) who did not receive aspirin as part of their anticoagulation regimen experienced fewer complications from bleeding and were associated with reduced hospital visits compared to patients who received aspirin daily after implantation of the device.

The ARIES international, placebo-controlled, randomized clinical study assessed whether the absence of aspirin was safe and decreased bleeding in patients implanted with the HeartMate 3. The data from the ARIES trial may potentially shift how physicians manage patients living with a HeartMate 3 heart pump, stated the company.

The findings were presented during a late-breaking science session at the 2023 AHA scientific sessions held November 11-13 in Philadelphia, Pennsylvania.

According to Abbott, ARIES met its primary endpoint, demonstrating noninferiority for HeartMate 3 patients who did not receive aspirin but continued using the standard postimplantation vitamin-K antagonist (VKA) treatment regimen versus patients who also received aspirin. The HeartMate 3 patients who did not take aspirin spent 47% fewer days in the hospital which was because of an approximately 40% decrease in bleeding events compared to patients who continued to take aspirin daily.

Additionally, the ARIES trial revealed cost savings for heart failure patients who did not take aspirin after implantation of a HeartMate 3 LVAD. At 1-year, there was a 41% reduction in estimated costs related to bleeding events. The data also found this same group had no elevated risk of developing thrombosis.

The international, randomized study of either aspirin (100 mg/day) or placebo with VKA therapy in advanced heart failure patients with the HeartMate 3 LVAD was conducted across 51 centers in the United States, Canada, the United Kingdom, France, Italy, Austria, the Czech Republic, Kazakhstan, and Australia. More than 600 patients were enrolled between July 2020 and September 2022.

“The ARIES study moves the needle forward in improving the journey of advanced heart failure patients with a marked improvement in bleeding events, healthcare resource use, and cost-savings by a simple decision to avoid the use of aspirin,” commented Mandeep R. Mehra, MD, in Abbott’s press release. “The data are so compelling that the magnitude of benefit observed in avoiding aspirin is similar to the impact of introducing a new device to the market.” Dr. Mehra is Executive Director of the Center for Advanced Heart Disease and the William Harvey Distinguished Chair at Brigham and Women’s Hospital in Boston, Massachusetts

Robert Kormos, MD, who is Divisional Vice President, Gobal Medical Affairs, for Abbott’s heart failure business, stated in the company’s press release, “There is a general consensus within the medical community that aspirin use should be a mandatory part of the treatment regimen for heart failure patients living with an LVAD; however, those assumptions were largely driven by observational data that have rarely been challenged.

“The ARIES trial estimates that for every 100 people with the HeartMate 3, not taking aspirin prevents nearly 15 major bleeding events within their first year with the device. That equates to many more moments these patients can spend with their loved ones living a fuller life.”

The HeartMate 3 LVAD is indicated for providing short- and long-term mechanical circulatory support in adult and pediatric patients with advanced refractory left ventricular heart failure and with an appropriate body surface area. It is contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.

The new clinical approach for patient management evaluated in the ARIES clinical study has not been reviewed by the FDA and labeling changes related to the study’s anticoagulation regimen have not been approved by the FDA, advised Abbott.