Aspirin and left ventricular assist devices: rationale and design for the international randomized, placebo-controlled, non-inferiority ARIES HM3 trial
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Aims: Over decades, left ventricular assist device (LVAD) technology has transitioned from less durable bulky pumps to smaller continuous-flow pumps which have substantially improved long-term outcomes and quality of life. Contemporary LVAD therapy is beleaguered by haemocompatibility-related adverse events including thrombosis, stroke and bleeding. A fully magnetically levitated pump, the HeartMate 3 (HM3, Abbott, USA) LVAD, has been shown to be superior to the older HeartMate II (HMII, Abbott, USA) pump by improving haemocompatibility. Experience with the HM3 LVAD suggests near elimination of de-novo pump thrombosis, a marked reduction in stroke rates, and only a modest decrease in bleeding complications. Since the advent of continuous-flow LVAD therapy, patients have been prescribed a combination of aspirin and anticoagulation therapy on the presumption that platelet activation and perturbations to the haemostatic axis determine their necessity. Observational studies in patients implanted with the HM3 LVAD who suffer bleeding have suggested a signal of reduced subsequent bleeding events with withdrawal of aspirin. The notion of whether antiplatelet therapy can be avoided in an effort to reduce bleeding complications has now been advanced. Methods: To evaluate this hypothesis and its clinical benefits, the Antiplatelet Removal and Hemocompatibility Events with the HeartMate 3 Pump (ARIES HM3) has been introduced as the first-ever international prospective, randomized, double-blind and placebo-controlled, non-inferiority trial in a patient population implanted with a LVAD. Conclusion: This paper reviews the biological and clinical role of aspirin (100 mg) with LVADs and discusses the rationale and design of the ARIES HM3 trial.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | European Journal of Heart Failure |
| Vol/bind | 23 |
| Udgave nummer | 7 |
| Sider (fra-til) | 1226-1237 |
| Antal sider | 12 |
| ISSN | 1388-9842 |
| DOI | |
| Status | Udgivet - 2021 |
Bibliografisk note
Funding Information:
ARIES HM3 (NCT04069156) is funded by Abbott (Chicago, IL). Conflict of interest: M.R.M. reports payments made to his institution from Abbott for consulting; consultant fees from Medtronic, Janssen, Mesoblast, Portola, Bayer, Triple Gene, and Baim Institute for Clinical Research. Scientific Advisory Board Member for NuPulseCV, Leviticus and FineHeart. D.L.C. is an employee of Abbott, the sponsor of the study. F.G. reports honoraria from Abbott, Bayer, Pfizer, Alnylam, Boehringer Ingelheim Amgen, Pharmacosmos and Idorisa for consulting, and speaker fees from Novartis, AstraZeneca, Orion Pharma, and Vifor. U.P.J. reports honoraria from Abbott. J.N.K. reports consulting fees from Abbott. I.N. reports grants, personal fees and non-financial support from Abbott during the conduct of the study; grants, personal fees and non-financial support from CARMAT SA outside of the submitted work; non-financial support and other from LeviticusCardio Ltd. outside of the submitted work; personal fees and non-financial support from Evaheart Inc. outside the submitted work. N.U. reports consulting fees from Abbott and Medtronic and is on the scientific advisory board of Leviticus Cardio Ltd. J.M.C. reports honoraria from Abbott, Bristol-Myers Squibb, Pfizer, Portola, Takeda and research funding to the institution from CSL Behring. P.S. is an employee of Abbott, the sponsor of the study. G.H. is an employee of Abbott, the sponsor of the study. F.D.P. reports that he is on the scientific advisory board of FineHeart, Data Safety and Monitoring Board for CARMAT SA and the NHLBI PumpKIN Trial. Additionally, he is a task force chair for the STS INTERMACS.
Funding Information:
ARIES HM3 (NCT04069156) is funded by Abbott (Chicago, IL).
Publisher Copyright:
© 2021 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.
ID: 303035877