Aspirin-Free Regimen Lowers Bleeding Events in Patients With Heartmate 3 Heart Pump

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Recent data show Abbott’s HeartMate 3 heart pump may improve the treatment of patients with advanced heart failure. Findings from the ARIES trial show that patients with advanced heart failure not taking aspirin as part of their blood-thinning medication regimen had fewer complications from bleeding with lower hospital visits vs. patients who took aspirin daily following their implant.

According to Abbott, these data may alter how physicians manage patients with a HeartMate 3 heart pump.

"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," Mandeep R. Mehra, MD, executive director of the Center for Advanced Heart Disease and the William Harvey Distinguished Chair at Brigham and Women's Hospital, said in a 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."

The international, placebo-controlled, randomized ARIES clinical trial evaluated whether the absence of aspirin is safe and lowers the risk of bleeding in patients with the HeartMate 3 left ventricular assist device (LVAD). The trial, which included more than 600 patients, showed that patients with HeartMate 3 who were not taking aspirin as part of their regimen but continued use of the standard post-implant vitamin-K antagonist treatment regimen achieved the primary endpoint of non-inferiority for no aspirin vs. aspirin

The HeartMate 3 cohort who did not take aspirin experienced 47% fewer days in the hospital with an approximately 40% drop in bleeding events vs. patients taking aspirin daily. Although HeartMate 3 was associated with fewer complications vs. previous generation heart pumps, bleeding is still the primary cause of rehospitalizations in patients with advanced heart failure.

“The ARIES trial demonstrated a reduction in bleeding events in patients without aspirin, which could lead to an important change in management of patients with a HeartMate 3,” Abbott stated in a press release.

In addition to the findings for reduced bleeding events, ARIES also showed cost-savings for patients with heart failure who did not take aspirin following use of the HeartMate 3 pump, according to Abbott.

Data show a 41% drop in estimated costs related to bleeding events at one year after receiving the pump along with no increased risk in the development of thrombosis.

"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," Robert Kormos, MD, divisional vice president, global medical affairs, Abbott's heart failure business, said in a press release. "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."
HeartMate 3 is indicated for 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.

"Abbott has focused its investments on ways that we can continue to improve the outcomes for the thousands of patients a year who are eligible to receive a heart pump," said Keith Boettiger, vice president, Abbott's heart failure business, in a press release. "With the ARIES trial, we've identified an important new approach to patient management that doctors can consider to reduce bleeding risk for their patients and make LVAD therapy more accessible to patients who need this life-saving device."

Reference

Late-Breaking Data Show an Aspirin-Free Medication Regimen Benefits People With Abbott's Heartmate 3™ Heart Pump. Abbott. News release. Accessed December 14, 2023. https://abbott.mediaroom.com/2023-11-13-Late-Breaking-Data-Show-an-Aspirin-Free-Medication-Regimen-Benefits-People-with-Abbotts-HeartMate-3-TM-Heart-Pump