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Critical Appraisal of Contemporary Clinical Endpoint Definitions in Coronary Intervention Trials A Guidance Document
Cardialysis Core Labs, Rotterdam, Netherlands;Clin Trial Management, Rotterdam, Netherlands;Erasmus MC, Thoraxctr, Dept Cardiol, Rotterdam, Netherlands.
Cork Univ Hosp, Dept Cardiol, Cork, Ireland.
Hasselt Univ, Hartctr Hasselt, Dept Cardiol & Crit Care Med, Fac Med & Life Sci,Jessa Ziekenhuis, Hasselt, Belgium.
MedStar Washington Hosp Ctr, Dept Cardiol, Washington, DC USA.
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2019 (English)In: JACC: Cardiovascular Interventions, ISSN 1936-8798, E-ISSN 1876-7605, Vol. 12, no 9, p. 805-819Article, review/survey (Refereed) Published
Abstract [en]

The Academic Research Consortium (ARC) and the Standardized Data Collection for Cardiovascular Trials Initiative have recently published updated clinical and angiographic endpoint definitions for percutaneous coronary intervention trials. The aim of this document is to provide practical guidance to facilitate and harmonize the implementation of those definitions in randomized trials or registries, as well as to foster consistency among independent adjudication committees. The authors compared the ARC-2 and Standardized Data Collection for Cardiovascular Trials Initiative definitions to identify areas of consistency, complex scenarios, and definitions in need of further standardization. Furthermore, the authors compared the fourth universal definition of myocardial infarction with the ARC-2 definition of myocardial infarction. The Society for Cardiovascular Angiography and Interventions definition of periprocedural myocardial infarction was also compared with the ARC-2 definition and the fourth universal definition of myocardial infarction. An in-depth assessment was done for each individual clinical endpoint to guide clinical investigators on reporting and classifying clinical adverse events. Finally, the authors propose standard streamlined data capture templates for reporting and adjudicating death, myocardial infarction, stroke, revascularization, stent or scaffold thrombosis, and bleeding. (c) 2019 by the American College of Cardiology Foundation.

Place, publisher, year, edition, pages
Elsevier, 2019. Vol. 12, no 9, p. 805-819
Keywords [en]
bleeding, clinical endpoint adjudication, clinical endpoint definition, death, myocardial infarction, revascularization, scaffold thrombosis, stent thrombosis, stroke
National Category
Cardiac and Cardiovascular Systems
Identifiers
URN: urn:nbn:se:uu:diva-384078DOI: 10.1016/j.jcin.2018.12.031ISI: 000466940300004PubMedID: 31072504OAI: oai:DiVA.org:uu-384078DiVA, id: diva2:1326727
Available from: 2019-06-18 Created: 2019-06-18 Last updated: 2019-06-18Bibliographically approved

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