FDA Approves Dropping Aspirin for HeartMate 3 LVAD Patients

Pharmacotherapy for advanced heart failure patients with a HeartMate 3 left ventricular assist device (LVAD) is being simplified following US Food and Drug Administration approval of a labeling change that eliminates aspirin from the antithrombotic regimen, device maker Abbott announced today.

The FDA’s decision is based on data from the international ARIES-HM3 trial. As TCTMD previously reported, the study found that an aspirin-free regimen, compared with low-dose aspirin plus vitamin K antagonist therapy, was associated with fewer bleeding events and no increased risk of stroke or other thromboembolic events at 12 months across diverse subgroups of patients.

The ARIES-HM3 investigators estimated that for every 100 patients, avoiding aspirin would prevent 14.5 major bleeding events in the first year after LVAD implantation. As a result of fewer bleeding events, going aspirin-free was projected to decrease days spent in the hospital by 47% and cost of care for bleeding encounters by 41%.

In a press release announcing the approval of the labeling change request, Abbott noted that the elimination of aspirin from the therapeutic regimen applies exclusively to patients who receive a HeartMate 3 device, and that this change has also been approved by regulatory agencies in Canada and the European Union.