Critical Appraisal of Contemporary Clinical Endpoint Definitions in Coronary Intervention Trials

• Published in: JACC. Cardiovascular interventions 2019-05, Vol.12 (9), p.805-819
• Main Authors: Spitzer, Ernest, McFadden, Eugene, Vranckx, Pascal, Garcia-Garcia, Hector M., Seltzer, Jonathan H., Held, Claes, de Vries, Ton, Menon, Venu, Brown, Kimberly J., Soliman, Osama I.I., Onuma, Yoshinobu, Lopes, Renato D., Stone, Gregg W., Cutlip, Donald E., Serruys, Patrick W.
• Format: Article
• Language: English
• Subjects: bleeding; clinical endpoint adjudication; clinical endpoint definition; death; myocardial infarction; revascularization; scaffold thrombosis; stent thrombosis; stroke
• ISSN: 1936-8798; 1876-7605
• DOI: 10.1016/j.jcin.2018.12.031

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. [Display omitted] •Clinical trials utilize standardized clinical endpoint definitions for consistency, comparability, and poolability purposes.•In 2018, the Academic Research Consortium and the Standardized Data Collection for Cardiovascular Trials Initiative published updated clinical and angiographic endpoint definitions for percutaneous coronary intervention trials.•This article provides practical guidance to facilitate and harmonize implementation of these definitions in randomized trials or registries, as well as to foster consistency among independent adjudication committees, including standard, streamlined data-capture templates for reporting and adjudicating death, myocardial infarction, stroke, revascularization, stent/scaffold thrombosis, and bleeding.•Continued collaborative efforts among academia, industry, regulatory agencies, and societies are critical to maintain and monitor consistency across ongoing and future clinical trials.