ADAPT-CEC: adaptief AI-algoritme voor cardiovasculaire event-adjudicatie in klinische trials

Background: Clinical endpoint classification (CEC) is the gold standard for cardiovascular endpoint measurement in clinical trials, but adds time and cost. We developed and validated an artificial intelligence (AI) algorithm (ADAPT-CEC) that adjudicates multiple cardiovascular endpoints and adapts to new definitions.Methods: ADAPT-CEC was derived on myocardial infarction (MI), stroke, and heart failure from the ODYSSEY OUTCOMES trial and externally validated on MI, stroke, bleeding and CV death from the EUCLID trial after adaptation with 20 EUCLID suspected events per endpoint. ADAPT-CEC was compared via F1 score with direct generative pretrained transformer (GPT) 4.0 adjudication and a hybrid approach where the 30% of suspected events with the lowest AI prediction certainty used human adjudication. The EUCLID primary endpoint of CV death, MI, or stroke was re-estimated for all three adjudication strategies.Results: Amongst 13,885 suspected EUCLID primary endpoint events, ADAPT CEC, hy