Hemocompatibility outcomes with pharmacological therapy following LVAD implantation: Insights from the ARIES-HM3 trial

Authors

Jason N. Katz, Division of Cardiology, Department of Medicine, NYU Grossman School of Medicine and Bellevue Hospital, New York, New York, USA.
Jean M. Connors, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Francis D. Pagani, University of Michigan, Ann Arbor, Michigan, USA.
Ulrich P. Jorde, Division of Cardiology, Montefiore Medical Center, Albert Einstein College of Medicine, New York, New York, USA.
Finn Gustafsson, Abbott, Abbott Park, Illinois, USA.
Nir Uriel, Division of Cardiology, Columbia University Irving Medical Center, New York-Presbyterian Hospital, New York, New York, USA.
Ivan Netuka, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
Mirnela Byku, Division of Cardiology, Department of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.
Anelechi Anyanwu, Department of Cardiovascular Surgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Mary Keebler, Department of Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Sriram Nathan, Department of Advanced Cardiopulmonary Therapeutics and Transplantation, McGovern Medical School, University of Texas Health Science Center, Houston, Texas, USA.
Craig H. Selzman, Division of Cardiothoracic Surgery, University of Utah Health, Salt Lake City, Utah, USA.
Jeffrey D. Alexis, Division of Cardiology, School of Medicine and Dentistry, University of Rochester, Rochester, New York, USA.
Nasir Sulemanjee, Advocate Health - MidwestFollow
Pavan Atluri, Division of Cardiovascular Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
David D'Allesandro, Division of Cardiac Surgery, Massachusetts General Hospital, Boston, Massachusetts, USA.
Sydney Porter, Abbott, Abbott Park, Illinois, USA.
Fei San Lee, Abbott, Abbott Park, Illinois, USA.
Mandeep R. Mehra, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. Electronic address: mmehra@bwh.harvard.edu.

Affiliations

Aurora St. Luke's Medical Center

Abstract

Background: The ARIES-HM3 (Antiplatelet Removal and Hemocompatibility Events With the HeartMate 3 Pump) trial demonstrated safety and decreased bleeding in eliminating aspirin from the antithrombotic regimen of patients implanted with a HM3 left ventricular assist device (LVAD). Whether pharmacologic therapies impact hemocompatibility-related adverse events (HRAEs) remains uncertain.

Objectives: In this trial analysis, the authors investigated associations between pharmacologic therapy and hemocompatibility outcomes.

Methods: Among 547 of 589 randomized patients who were discharged, non-inotrope-dependent, and completed 1-month of follow-up, the study explored the influence of pharmacotherapy (renin-angiotensin-aldosterone system [RAAS] inhibitors, heart failure [HF]-related and other cardiovascular drugs) on blood pressure control and on survival free of major nonsurgical HRAE (stroke, pump thrombosis, bleeding, and arterial thromboembolism) at 12 months.

Results: In 547 eligible patients, 65% received RAAS inhibitors, 89% received other HF-related therapy, and 82% received another cardiovascular drug at 1 month. No statistically significant interaction between RAAS inhibitors (P = 0.08), other HF-related therapies (P = 0.65), or other cardiovascular drugs (P = 0.92) on aspirin use and primary endpoint success was observed. Patients receiving RAAS inhibitors at 1 month had greater primary endpoint success (78.9% vs 69.3%, HR: 0.61 [95% CI: 0.37-1.01]; P = 0.14). Other HF-related therapies and cardiovascular drugs were not associated with primary event success either on or off prescription (HF-related therapy: 75.4% vs 76.7%; other cardiovascular drugs: 74.3% vs 81.3%). Pharmacologic therapy did not have a significant interaction with blood pressure control (RAAS inhibitors: P = 0.69; other HF-related therapy: P = 0.40).

Conclusions: Background pharmacologic therapy did not modify the effect of aspirin on HRAE; however, the use of a RAAS inhibitor was independently associated with a reduction in HRAE. These exploratory observations may potentially point to opportunity for enhancing hemocompatibility in patients receiving LVAD therapy. (Antiplatelet Removal and Hemocompatibility Events With the HeartMate 3 Pump [ARIES-HM3]; NCT04069156).

Type

Article

PubMed ID

41258850


 

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