Withdrawal of aspirin in patients with left ventricular assist device treated with vitamin K antagonists: impact of anticoagulation quality in the randomized ARIES-HM3 trial

作者：Jean M. Connors, Finn Gustafsson, Nir Uriel, Francis D. Pagani, Ulrich P. Jorde, Jason N. Katz, Ivan Netuka, Daniel Zimpfer, Hassan Nemeh, J. Ransom, Richa Agarwal, Mirnela Byku, Michael M. Givertz, Shelley Hall, Manreet Kanwar, Rebecca Cogswell, Farooq H. Sheikh, Anita Phancao, Ashwin Ravichandran, Jennifer Conway, Eric Adler, Eugene Chung, Jonathan Grinstein, Nick Dirckx, Nourdine Chakouri, Mandeep R. Mehra · 发表于：European Heart Journal · 年份：2025 · DOI：10.1093/eurheartj/ehaf745 · 被引用次数：6 · 研究领域：Mechanical Circulatory Support Devices、Atrial Fibrillation Management and Outcomes、Heparin-Induced Thrombocytopenia and Thrombosis

BACKGROUND AND AIMS: Left ventricular assist devices (LVADs), including the HeartMate 3 (HM3), have improved outcomes in patients with advanced heart failure. Use of vitamin K antagonists (VKA) is mandated to reduce the risk of thrombotic events, but there is heterogeneity in management. Time in therapeutic range (TTR) is a crucial metric for assessing the quality of VKA management. The ARIES-HM3 trial demonstrated that aspirin can be safely omitted from the antithrombotic regimen, resulting in reduced bleeding without increased thrombosis. This pre-specified trial analysis explores the relationship of quality of VKA management assessed by TTR with haemocompatibility-related outcomes. METHODS: ARIES-HM3 was an international, randomized, double-blind, placebo-controlled study of aspirin (100 mg/day) or placebo (1:1) with VKA therapy in patients with de-novo HM3 placement. Participants were stratified into low TTR or high TTR groups based on median levels (n = 554). Primary endpoint success and secondary endpoint rates were stratified based on TTR groups. Bleeding rates at 12 months were estimated using an Andersen-Gill model with TTR as a single continuous variable, and multivariable regression analysis was performed. RESULTS: The percentage of patients with a TTR above or below the median of 56 was similar between the aspirin and placebo groups. More participants achieved primary endpoint success with TTR ≥56% (77% vs 66.9%, P = .01). Higher TTR was associated with lower blee...