The Impact of Aspirin Dose on Hemocompatibility-Related Adverse Events during HeartMate 3 Support - An Analysis from the MOMENTUM 3 Trial

O. Saeed, P. C. Columbo, M. R. Mehra, N. Uriel, D. J. Goldstein, J. C. Cleveland, J. M. Conners, S. S. Najjar, N. A. Mokadam, A. Bansal, D. L. Crandall, P. Sood, U. P. Jorde

Research output: Contribution to journalArticle

Abstract

PURPOSE: Antiplatelet therapy with aspirin (ASA) is mandated with Left Ventricular Assist Devices (LVADs) on the presumption that this therapy modulates Hemocompatibility-related adverse events (HRAEs). The effect of aspirin (ASA) dosing, particularly during support with the HeartMate 3 (HM3) LVAD is unknown. METHODS: We conducted an exploratory analysis of HM3 supported patients in the MOMENTUM 3 clinical trial. HM3 patients were categorized into 2 groups based on daily ASA dose as Usual-dose (325 mg) or Low-dose (81 mg) with anticoagulation targeted to an INR 2.0-3.0. Exclusion criteria included patients not receiving either ASA 81mg or 325mg dose, those with HRAEs ≤7 days after LVAD implantation, or those receiving >1 antiplatelet agent. The composite primary endpoint was freedom from HRAEs, including non-surgical bleeding, pump thrombosis, stroke and peripheral arterial thromboembolic events at 2 years. RESULTS: Overall, 321 HM3 patients (Usual-dose n=141; Low-dose n=180) were included. Patients in the Usual-dose group were younger (57±13 vs. 60±12 years, p=0.035) and less often implanted as destination therapy (55% vs. 67%, p=0.029) than those receiving Low-dose. INR at the time of HRAEs was clinically similar between Usual- and Low-dose groups (2.20 [1.66, 3.20] vs. 2.0 [1.50, 2.60], p=0.054 respectively). At 2 years, a similar proportion of patients in the Usual- and Low-dose (43.5% vs 45.3%, p=0.94, Figure 1) groups survived free from HRAEs. There were no differences in survival free from component hemorrhagic (Usual-dose: 54.4% vs Low-dose: 51.7%, p=0.42) and thrombotic (Usual-dose: 76.8% vs Low-dose: 75.7%, p=0.92) events. CONCLUSION: At 2-years after HM 3 LVAD implant, no difference in HRAEs between Usual- and Low-dose ASA was shown in the MOMENTUM 3 clinical trial. These findings suggest similar efficacy and safety of these two distinct aspirin dose ranges and call into question any meaningful therapeutic effect of this agent in HM 3 treated patients.

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine
  • Transplantation

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