ArticleJournal of the American Heart Association2025
Thromboembolic Events in the Hemodialysis Setting: Understanding Risk Profiles and Cumulative Incidences to Inform Clinical Trial Design.
Article in Journal of the American Heart Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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9 authors.
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Abstract
backgroundPeople with kidney failure have a high risk of cardiovascular morbidity/death, including thromboembolic events. Factor XIa inhibitors are a new class of anticoagulants in development that may offer antithrombotic benefits with a lower risk of incremental bleeding events than traditional therapies. We investigated major adverse vascular events (MAVEs), a relevant composite outcome for testing novel antithrombotic agents, in a large cohort of patients on hemodialysis, to better understand the key requirements to adequately design a phase 3 trial. METHODS AND
resultsWe included 25 211 patients on hemodialysis for >90 days in phases 4 to 7 (2009-2021) of the DOPPS (Dialysis Outcomes and Practice Patterns Study). Atherosclerotic cardiovascular disease (ASCVD) was defined as history/presence of coronary, peripheral, or cerebrovascular disease. We estimated MAVE rates and cumulative incidence, overall and by ASCVD. Over half (52%) of the cohort met the ASCVD criteria. The MAVE hospitalization/death composite rate (per 100 patient-years) was 6.0 in the overall cohort and 8.7 in the ASCVD subset. Three-year cumulative incidence of MAVE was 13% in the overall cohort and 18% in the ASCVD subset. The estimated sample size to be randomized in a hypothetical trial in the ASCVD population was ≈7000 patients.
conclusionsEven in the enriched ASCVD group, the observed MAVE incidence combined with a high competing risk, regulatory requirements (α=0.01), and limited recruitment pool makes feasibility of a potential randomized trial targeting MAVE reduction challenging. These results highlight key considerations and challenges for developers of novel therapies targeting systemic thromboembolic events in patients on hemodialysis.
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