ARIES-HM3 is an international, randomized, double-blind, placebo-controlled study of either aspirin (N=293) or placebo with Vitamin K antagonists (warfarin) therapy (n=296) in patients with advanced heart failure supported with a HeartMate 3™ LVAD.
The composite primary endpoint was, assessed for non-inferiority of the aspirin-free regimen, survival free of a major non-surgical hemocompatibility related adverse event at 12 months. HRAEs include stroke, pump thrombosis, major bleeding or arterial peripheral thromboembolism. The principal secondary endpoint was non-surgical bleeding events.
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The ARIES-HM3 clinical study evaluated a new clinical approach to patient management, and the data is currently not reviewed by the FDA. Labeling changes related to the anticoagulation regimen have not been approved by the FDA at this time.