Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure: The ARIES-HM3 Randomized Clinical Trial

Mehra M.R. Netuka I. Uriel N. Katz J.N. Pagani F.D. Jorde U.P. Gustafsson F. Connors J.M. Ivak P. Cowger J. Ransom J. Bansal A. Takeda K. Agarwal R. Byku M. Givertz M.M. Bitar A. Hall S. Zimpfer D. Vega J.D. Kanwar M.K. Saeed O. Goldstein D.J. Cogswell R. Sheikh F.H. Danter M. Pya Y. Phancao A. Henderson J. Crandall D.L. Sundareswaran K. Soltesz E. Estep J.D.
12 December 2023 American Medical Association

JAMA
2023 #330 Issue 22 2171 - 2181 pp.

IMPORTANCE: Left ventricular assist devices (LVADs) enhance quality and duration of life in advanced heart failure. The burden of nonsurgical bleeding events is a leading morbidity. Aspirin as an antiplatelet agent is mandated along with vitamin K antagonists (VKAs) with continuous-flow LVADs without conclusive evidence of efficacy and safety. OBJECTIVE: To determine whether excluding aspirin as part of the antithrombotic regimen with a fully magnetically levitated LVAD is safe and decreases bleeding. DESIGN, SETTING, and PARTICIPANTS: This international, randomized, double-blind, placebo-controlled study of aspirin (100 mg/d) vs placebo with VKA therapy in patients with advanced heart failure with an LVAD was conducted across 51 centers with expertise in treating patients with advanced heart failure across 9 countries. The randomized population included 628 patients with advanced heart failure implanted with a fully magnetically levitated LVAD (314 in the placebo group and 314 in the aspirin group), of whom 296 patients in the placebo group and 293 in the aspirin group were in the primary analysis population, which informed the primary end point analysis. The study enrolled patients from July 2020 to September 2022; median follow-up was 14 months. Intervention: Patients were randomized in a 1:1 ratio to receive aspirin (100 mg/d) or placebo in addition to an antithrombotic regimen. MAIN OUTCOMES AND MEASURES: The composite primary end point, assessed for noninferiority (-10% margin) of placebo, was survival free of a major nonsurgical (>14 days after implant) hemocompatibility-related adverse events (including stroke, pump thrombosis, major bleeding, or arterial peripheral thromboembolism) at 12 months. The principal secondary end point was nonsurgical bleeding events. RESULTS: Of the 589 analyzed patients, 77% were men; one-third were Black and 61% were White. More patients were alive and free of hemocompatibility events at 12 months in the placebo group (74%) vs those taking aspirin (68%). Noninferiority of placebo was demonstrated (absolute between-group difference, 6.0% improvement in event-free survival with placebo [lower 1-sided 97.5% CI, -1.6%]; P <.001). Aspirin avoidance was associated with reduced nonsurgical bleeding events (relative risk, 0.66 [95% confidence limit, 0.51-0.85]; P =.002) with no increase in stroke or other thromboembolic events, a finding consistent among diverse subgroups of patient characteristics. CONCLUSIONS AND RELEVANCE: In patients with advanced heart failure treated with a fully magnetically levitated LVAD, avoidance of aspirin as part of an antithrombotic regimen, which includes VKA, is not inferior to a regimen containing aspirin, does not increase thromboembolism risk, and is associated with a reduction in bleeding events. 2023 American Medical Association. All rights reserved.

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Brigham and Womens Hospital, Harvard Medical School, Boston, MA, United States
Institute for Clinical and Experimental Medicine, Prague, Czech Republic
Columbia University College of Physicians and Surgeons, New York Presbyterian Hospital, New York, United States
Duke University Medical Center, Durham, NC, United States
University of Michigan, Ann Arbor, United States
Montefiore Einstein Center for Heart and Vascular Care, New York, NY, United States
Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
Henry Ford Hospital, Detroit, MI, United States
Baptist Health Medical Center, Little Rock, AR, United States
Ochsner Medical Center, New Orleans, LA, United States
University of North Carolina at Chapel Hill, Chapel Hill, United States
Baylor University Hospital, Dallas, TX, United States
Medical University of Vienna, Vienna, Austria
Emory University Hospital, Atlanta, GA, United States
Allegheny Health Network, Pittsburgh, PA, United States
University of Minnesota Medical Center Fairview, Minneapolis, United States
Medstar Washington Hospital Center, Washington, DC, United States
Kansas University Medical Center, Kansas City, United States
National Research Center for Cardiac Surgery, Kazakhstan
Miami Transplant Institute - Jackson Memorial, Miami, FL, United States
Abbott, Chicago, IL, United States
The Cleveland Clinic Foundation, Cleveland, OH, United States

Brigham and Womens Hospital
Institute for Clinical and Experimental Medicine
Columbia University College of Physicians and Surgeons
Duke University Medical Center
University of Michigan
Montefiore Einstein Center for Heart and Vascular Care
Rigshospitalet
Henry Ford Hospital
Baptist Health Medical Center
Ochsner Medical Center
University of North Carolina at Chapel Hill
Baylor University Hospital
Medical University of Vienna
Emory University Hospital
Allegheny Health Network
University of Minnesota Medical Center Fairview
Medstar Washington Hospital Center
Kansas University Medical Center
National Research Center for Cardiac Surgery
Miami Transplant Institute - Jackson Memorial
Abbott
The Cleveland Clinic Foundation

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