{"id":"b8da8a38d1b5","type":"article","url":"https://hartvaat.nl/2021/10/12/reductie-in-ischemische-events-door-onderzoekers-en-adjudicatiecommissie-reduce-/","title":"Reductie in ischemische events door onderzoekers en adjudicatiecommissie: REDUCE-IT","title_en":"Comparative Reductions in Investigator-Reported and Adjudicated Ischemic Events in REDUCE-IT.","category":"cholesterol","category_label":"Cholesterol","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2021.08.009","source_url":"https://doi.org/10.1016/j.jacc.2021.08.009","authors":["Prakriti Gaba","Deepak L Bhatt","Robert P Giugliano","Ph Gabriel Steg","Michael Miller","Eliot A Brinton","Terry A Jacobson","Steven B Ketchum","Rebecca A Juliano","Lixia Jiao","Ralph T Doyle","Craig Granowitz","Jean-Claude Tardif","Christie M Ballantyne","Duane S Pinto","Matthew J Budoff","C Michael Gibson"],"significance":5,"published":"2021-10-12","source_date":"2021-10-12","image":"","kennis":[],"congress":"","summary_en":"This REDUCE-IT analysis compared investigator-reported with centrally adjudicated ischemic events, showing consistent treatment effects regardless of event ascertainment method, strengthening the trial's internal validity.","created":"2026-07-03T10:29:26Z","updated":"2026-07-03T13:28:34Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"REDUCE-IT vergelijking van onderzoekers-gerapporteerde versus geadjudiceerde ischemische events.","abstract_original":"BACKGROUND: REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial) randomized statin-treated patients with elevated triglycerides to icosapent ethyl (IPE) or placebo. There was a significant reduction in adjudicated events, including the primary endpoint (cardiovascular [CV] death, myocardial infarction [MI], stroke, coronary revascularization, unstable angina requiring hospitalization) and key secondary endpoint (CV death, MI, stroke) with IPE. OBJECTIVES: The purpose of this study was to determine the effects of IPE on investigator-reported events. METHODS: Potential endpoints were collected by blinded site investigators and subsequently adjudicated by a blinded Clinical Endpoint Committee (CEC) according to a prespecified charter. Investigator-reported events were compared with adjudicated events for concordance. RESULTS: There was a high degree of concordance between investigator-reported and adjudicated endpoints. The simple Kappa statistic between CEC-adjudicated vs site-reported events for the primary endpoint was 0.89 and for the key secondary endpoint was 0.90. Based on investigator-reported events in 8,179 randomized patients, IPE significantly reduced the rate of the primary endpoint (19.1% vs 24.6%; HR: 0.74 [95% CI: 0.67-0.81]; P < 0.0001) and the key secondary endpoint (10.5% vs 13.6%; HR: 0.75 [95% CI: 0.66-0.85]; P < 0.0001). Among adjudicated events, IPE similarly reduced the rate of the primary and key secondary endpoints. CONCLUSIONS: IPE led to consistent, significant reductions in CV events, including MI and coronary revascularization, as determined by independent, blinded CEC adjudication as well as by blinded investigator-reported assessment. These results highlight the robust evidence for the substantial CV benefits of IPE seen in REDUCE-IT and further raise the question of whether adjudication of CV outcome trial endpoints is routinely required in blinded, placebo-controlled trials. (Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT [Reduction of Cardiovascular Events With EPA - Intervention Trial]; NCT01492361)."}