Concomitant Surgical Procedures and Aspirin Avoidance With Left Ventricular Assist Device Therapy
- PMID: 40208135
- DOI: 10.1016/j.jchf.2025.01.017
Concomitant Surgical Procedures and Aspirin Avoidance With Left Ventricular Assist Device Therapy
Abstract
Background: ARIES-HM3 (Antiplatelet Removal and Hemocompatibility Events With the HeartMate 3 Pump) demonstrated that aspirin avoidance with a fully magnetically levitated HeartMate 3 (HM3) left ventricular assist device (LVAD) reduces bleeding complications and does not increase thromboembolism. Whether a concomitant surgical procedure modifies the observed safety and benefits remains uncertain.
Objectives: This prespecified analysis of ARIES-HM3 studied clinical outcomes when concomitant surgical procedures are performed during LVAD implantation with excluding aspirin but maintaining a vitamin K antagonist.
Methods: Among 628 patients randomized to receive either placebo or aspirin with a vitamin K antagonist, 589 (296 placebo and 293 aspirin) contributed to the primary endpoint analysis. Sub-categorization with receiving a concomitant surgical procedure (valvular procedure/coronary artery bypass grafting or nonvalvular procedure) was done and the composite primary endpoint of survival free from major nonsurgical (>14 days postimplant) hemocompatibility-related adverse events at 12 months was assessed.
Results: There were 155 (52%) and 145 (49%) concomitant procedures in placebo and aspirin arms, respectively. The percentage of subjects achieving primary endpoint success was higher with the placebo group in patients with a concomitant procedure, and no interaction was observed on primary outcomes between those with and without concomitant surgical procedures (Pint = 0.231, 0.298, and 0.735 for any procedure, valvular/coronary artery bypass grafting, and nonvalvular procedures, respectively). There was a similar reduction in nonsurgical major hemorrhagic events with placebo compared with aspirin, observed in patients with or without any concomitant procedure: 0.64 (95% CI: 0.44-0.94) and 0.66 (95% CI: 0.46-0.93).
Conclusions: Our findings support the safety and efficacy of aspirin avoidance from the antithrombotic regimen in HM3 LVAD patients undergoing concomitant surgical procedures. (Antiplatelet Removal and Hemocompatibility Events With the HeartMate 3 Pump [ARIES-HM3]; NCT04069156).
Keywords: aspirin; heart failure; hemocompatibility; left ventricular assist device; mechanical circulatory support.
Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Funding Support and Author Disclosures The ARIES-HM3 Study was funded by Abbott Inc. Dr Pagani has received University of Michigan contract research work with Abbott and BrioHealth Solutions during the conduct of the study and has roles as an ad hoc, noncompensated scientific advisor for Abbott, Medtronic, Berlin Heals, and FineHeart; and as a noncompensated medical monitor for Abiomed. Dr Netuka has received grants from CARMAT and FineHeart outside of the submitted work; personal fees from Abbott, CARMAT, Abiomed, and LeviticusCardio; and owns mutual funds or individual stocks of medical companies as part of a private family investment portfolio. Dr Jorde has received personal fees from Abbott committee outside of the submitted work. Dr Katz has received nonfinancial support from Abbott during the conduct of the study. Dr Gustafsson has received personal fees from Abbott during the conduct of the study; and personal fees from Bayer, Novartis, Pfizer, Alnylam, AstraZeneca, and FineHeart outside of the submitted work. Dr Connors has received personal fees from Abbott, Anthos, Bristol Myers Squibb, Roche, Sanofi, Werfen, and CSL Behring outside of the submitted work. Dr Uriel has received grants from Abbott, Abiomed, and Fire 1; personal fees from LiveMetric; and nonfinancial support from Revamp and Leviticus outside of the submitted work. Dr Soltesz has received honoraria from Abiomed, AtriCure, Abbott, Edwards, and Dillon; Cleveland Clinic has received clinical trial funds from Abbott. Dr Ivak has received institutional grants from Abbott, CARMAT, and FineHeart outside of the submitted work; and personal fees from Abbott and CARMAT. Dr Bitar has received University of Michigan contract research work with Abbott during the conduct of the study. Dr Vega has received institutional support for the ARIES trial. Dr Goldstein has received a consulting agreement at Abbott; is national Co-PI of the Momentum 3 trial; is a consultant and speaker at Abiomed; is national Co-PI of the IMPACT trial; and is a Scientific Advisory Board member at VGS Inc. Dr Danter has received consulting fees from Abbott outside of the submitted work. Dr Ravichandran is a speaker and has received advisor honoraria from Abbott. Dr Conway has received an unrestricted education grant from Abbott and is a medical monitor for the Pumpkin Trial. Dr Adler is chief medical officer and head of research for Lexeo Therapeutics. Dr Chung has received consultant fees from Abbott. Dr Grinstein is a speaker and consultant for Abbott; is a speaker for Abiomed, Medtronic, and BrioHealth; and is a shareholder of PAC Dynamic. Mr Dirckx and Dr Iravani are employees of Abbott. Dr Mehra has received consulting fees paid to Brigham and Women’s Hospital from Abbott during the conduct of the study, and personal fees from Moderna, Natera, Transmedics, Cadrenal, Second Heart Assist, Paragonix, NupulseCV, FineHeart, Fire-1, and Leviticus outside of the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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