Aspirin and Hemocompatibility after LVAD Implantation in Patients with Atherosclerotic Vascular Disease: A Secondary Analysis from the ARIES-HM3 Randomized Clinical Trial

Gustafsson F. Uriel N. Netuka I. Katz J.N. Pagani F.D. Connors J.M. Jorde U.P. Zimpfer D. Pya Y. Conway J. Anyanwu A. Scandroglio A.M. Sulemanjee N. Atluri P. Keebler M. Selzman C.H. Alexis J.D. Hayward C. Henderson J. Dirckx N. Gazzola C. Mehra M.R.
12 March 2025 American Medical Association

JAMA Cardiology
2025 #10 Issue 3 235 - 242 pp.

Importance: The Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure (ARIES-HM3) study demonstrated that aspirin may be safely eliminated from the antithrombotic regimen after HeartMate 3 (HM3 [Abbott Cardiovascular]) left ventricular assist device (LVAD) implantation. This prespecified analysis explored whether conditions requiring aspirin (prior percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG], stroke, or peripheral vascular disease [PVD]) would influence outcomes differentially with aspirin avoidance. Objective: To analyze aspirin avoidance on hemocompatibility-related adverse events (HRAEs) at 1 year after implant in patients with a history of CABG, PCI, stroke, or PVD. Design, Setting, and Participants: This was an international, multicenter, prospective, double-blind, placebo-controlled, randomized clinical trial including patients implanted with a de novo HM3 LVAD across 51 centers. Data analysis was conducted from April to July 2024. Interventions: Patients were randomized in a 1:1 ratio to receive aspirin (100 mg per day) or placebo, in addition to a vitamin K antagonist (VKA) targeted to an international normalized ratio of 2 to 3 in both groups. Main Outcomes and Measures: Primary end point (assessed for noninferiority) was a composite of survival free of any nonsurgical (>14 days after implant) HRAEs including stroke, pump thrombosis, bleeding, and arterial peripheral thromboembolism at 12 months. Secondary end points included nonsurgical bleeding, stroke, and pump thrombosis events. Results: Among 589 of 628 patients (mean [SD] age, 57.1 [13.7] years; 456 male [77.4%]) who contributed to the primary end point analysis, a history of PCI, CABG, stroke, or PVD was present in 41% (240 of 589 patients). There was no interaction between the presence of an atherosclerotic vascular condition and effect of aspirin compared with placebo (P for interaction=.23). The preset 10% noninferiority margin was not crossed for the studied subgroup of patients. Thrombotic events were rare, with no differences between aspirin and placebo in patients with and without vascular disease (P for interaction =.77). Aspirin treatment was associated with a higher rate of nonsurgical major bleeding events in the group with prior vascular condition history compared with those without aspirin (rate ratio for placebo compared with aspirin, 0.52; 95% CI, 0.35-0.79). Conclusions and Relevance: Results of this prespecified analysis of the ARIES-HM3 randomized clinical trial demonstrate that in patients with advanced heart failure who have classical indications for antiplatelet therapy use at the time of LVAD implantation, aspirin avoidance was safe and not associated with increased thrombosis risk. Importantly, elimination of aspirin was associated with no increased thrombosis but a reduction in nonsurgical bleeding events in patients with a history of PCI, CABG, stroke, or PVD. Trial registration: ClinicalTrials.gov Identifier: NCT04069156.

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Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital, New York, United States
Insitute for Clinical and Experimental Medicine, Prague, Czech Republic
NYU Grossman School of Medicine and Bellevue Hospital, New York, NY, United States
University of Michigan, Ann Arbor, United States
Brigham and Womens Hospital and Harvard Medical School, Boston, MA, United States
Montefiore Einstein Center for Heart and Vascular Care, New York, NY, United States
Medical University of Vienna, Vienna, Austria
University Medical Center, Astana, Kazakhstan
University of Alberta Hospital, Edmonton, AB, Canada
Mount Sinai Medical Center, New York, NY, United States
Ospedale San Raffaele, Milan, Italy
Aurora St Lukes Medical Center, Milwaukee, WI, United States
Hospital of the University of Pennsylvania, Philadelphia, United States
University of Pittsburgh Medical Center, Pittsburgh, PA, United States
University of Utah Hospital, Salt Lake City, United States
University of Rochester Medical Center, Rochester, NY, United States
St Vincents Hospital, Sydney, NSW, Australia
Abbott, Chicago, IL, United States
Brigham and Womens Hospital Heart and Vascular Center, Center for Advanced Heart Disease, Harvard Medical School, Boston, MA, United States

Rigshospitalet
Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital
Insitute for Clinical and Experimental Medicine
NYU Grossman School of Medicine and Bellevue Hospital
University of Michigan
Brigham and Womens Hospital and Harvard Medical School
Montefiore Einstein Center for Heart and Vascular Care
Medical University of Vienna
University Medical Center
University of Alberta Hospital
Mount Sinai Medical Center
Ospedale San Raffaele
Aurora St Lukes Medical Center
Hospital of the University of Pennsylvania
University of Pittsburgh Medical Center
University of Utah Hospital
University of Rochester Medical Center
St Vincents Hospital
Abbott
Brigham and Womens Hospital Heart and Vascular Center

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