ARIES-HM3 trial: Subgroup analysis in patients with prior need for aspirin

A post-hoc subanalysis of the ARIES HM3 trial showed that withholding aspirin in patients treated with the centrifugal flow HeartMate 3 (HM3) left ventricular assist device (LVAD) with a prior need for aspirin was not associated with increased thrombotic events in a modest number of patients, but was associated with a reduced risk of bleeding.

A new survival benchmark with contemporary LVAD therapy was heralded by the 5-year survival result of 58.4% with the HM3 in patients with advanced HF [1]. “The increased survival compared with earlier pump types is primarily related to improved haemocompatibility. However, we do still have a significant issue with bleeding in these patients, who are traditionally treated with a vitamin K antagonist and aspirin,” said Prof. Finn Gustafsson (University of Copenhagen, Denmark) [2]. The original ARIES HM3 trial showed that withdrawing aspirin from patients treated with the HM3 LVAD significantly reduced major non-surgical bleeding events by 34% (RR 0.66; 95% CI 0.51–0.85), without a significant increase in thromboembolic risk [3].

Prof. Gustafsson presented the results of a subgroup analysis of the ARIES HM3 trial of patients with a traditional indication for aspirin prior to LVAD implant, which included prior coronary revascularisation, cerebrovascular disease, and peripheral arterial disease [2]. Of the 589 included participants, 240 had a prior indication for aspirin, and 349 had not. Participants with a prior indication for aspirin were older, with a mean age of 62 years compared with 54 years among participants without a prior indication of aspirin (P<0.001). The primary composite endpoint was survival-free from stroke, pump thrombosis, major non-surgical bleeding, and arterial peripheral thromboembolism at 12 months.

The primary endpoint was met by 89 of 121 participants (73.6%) in the placebo group and 62 of 101 (61.4%) in the aspirin group. Despite the small number of events, there was no significant benefit for aspirin for the composite of survival free of non-surgical hemocompatibility-related adverse events at 12 months among participants with a prior indication for aspirin (success difference 12.2%; 95% CI -0.1 to 24.4) and without (success difference 2.6%; 95% CI -7.2 to 12.4; P_interaction=0.230). There was no difference in the risk of thromboembolic events between participants randomised to aspirin or placebo among participants with a prior indication for aspirin (RR 0.48; 95% CI 0.11–2.00) and without a prior indication (RR 0.64; 95% CI 0.15–2.70; P_interaction=0.773). Eliminating aspirin led to a consistent reduction in bleeding events: RR for participants with a prior indication for aspirin was 0.54 (95% CI 0.35–0.79) compared with 0.76 for participants without a prior indication for aspirin (95% CI 0.54–1.06). Prof. Gustafsson stressed the broad generalisability of this study's outcomes, as only very few participants were excluded from the trial.

1. 
   
   1. Mehra MR, et al. JAMA. 2022;328(12):1233-42.
   2. Gustafsson F, et al. Outcomes with aspirin avoidance after implantation of a Fully Magnetically Levitated LVAD in patients with coronary, cerebral or peripheral vascular disease: the ARIES HM3 randomized clinical trial. Late breaking clinical trials: LVAD, HFpEF and hypertrophic cardiomyopathy, Heart Failure 2024, 11–14 May, Lisbon, Portugal.
   3. Mehra MR, et al. JAMA. 2023;330(22):2171-81.

Copyright ©2024 Medicom Medical Publishers



Posted on 16 July 202416 July 2024