Abbott HeartMate 3 LVAD Gains FDA Approval for Aspirin-Free Regimen

August 21, 2024—Abbott announced that the FDA approved a change to the label for the company’s HeartMate 3 left ventricular assist device (LVAD) that eliminates aspirin as part of routine patient management. The labeling update is exclusively for patients with a HeartMate 3 heart pump and has also been approved by regulatory agencies in Canada and the European Union, advised Abbott.

According to the company, the ARIES-HM3 trial was conducted to help clinicians understand whether aspirin is needed as part of a blood-thinning regimen for HeartMate 3 patients. The trial showed that patients who received a HeartMate 3 but did not take aspirin as part of their blood-thinning medication regimen had approximately 40% fewer complications from bleeding, without increasing the risk of forming a blood clot compared to patients who received HeartMate 3 but did take aspirin.

As a result of reduced bleeding risk, the ARIES-HM3 trial also found that patients who avoided aspirin postimplant experienced reduced days in the hospital compared to patients who took aspirin daily, noted Abbott.

Mandeep R. Mehra, MD, Executive Director of the Center for Advanced Heart Disease and William Harvey Distinguished Chair at Brigham and Women’s Hospital in Boston, Massachusetts, serves as Principal Investigator of the ARIES-HM3 trial.

“Aspirin, along with warfarin, has traditionally been mandated for advanced heart failure patients living with an LVAD, but whether it contributes to excessive bleeding has been uncertain,” commented Dr. Mehra in Abbott’s press release. “The ARIES-HM3 trial, in which aspirin was removed from the medication regimen, provided important data challenging the assumption that patients with a heart pump must take aspirin daily. With this labeling change, physicians can avoid using aspirin in patients receiving the HeartMate 3 LVAD, a decision that is safe and decreases bleeding and its associated hospital visits.”

As summarized by Abbott in the press release, ARIES-HM3 was an international, randomized study of either aspirin (100 mg/day) or placebo with vitamin-K antagonist (VKA) therapy in advanced heart failure patients newly implanted with the HeartMate 3 LVAD (aged ≥ 18 years).

The study found that HeartMate 3 patients who did not receive aspirin but continued using the standard postimplant VKA treatment regimen met the primary endpoint by showing noninferiority of no aspirin to aspirin. HeartMate 3 patients who did not take aspirin spent 47% fewer days in the hospital because of an approximately 40% decrease in bleeding events compared to patients who continued to take aspirin daily. The data also found this same group had no elevated risk in developing thrombosis, stated Abbott.

In November 2023, Abbott announced that the ARIES-HM3 findings were presented at the 2023 American Heart Association scientific sessions held November 11-13 in Philadelphia, Pennsylvania.