MedStar Authors catalog › Details for: Critical Appraisal of Contemporary Clinical Endpoint Definitions in Coronary Intervention Trials: A Guidance Document. [Review]
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Critical Appraisal of Contemporary Clinical Endpoint Definitions in Coronary Intervention Trials: A Guidance Document. [Review]

by Garcia-Garcia, Hector M.
Citation: ; Jacc: Cardiovascular Interventions. 12(9):805-819, 2019 05 13..Journal: JACC. Cardiovascular interventions.Published: ; 2019; ISSN: 1936-8798.Full author list: Brown KJ; Cutlip DE; de Vries T; Garcia-Garcia HM; Held C; Lopes RD; McFadden E; Menon V; Onuma Y; Seltzer JH; Serruys PW; Soliman OII; Spitzer E; Stone GW; Vranckx P.UI/PMID: 31072504.Subject(s): Coronary Angiography/st [Standards] | Treatment Outcome | Time Factors | Terminology as Topic | Stents/st [Standards] | Risk Factors | Risk Assessment | *Research Design/st [Standards] | Recurrence | *Randomized Controlled Trials as Topic/st [Standards] | *Percutaneous Coronary Intervention/st [Standards] | Percutaneous Coronary Intervention/mo [Mortality] | Percutaneous Coronary Intervention/is [Instrumentation] | Percutaneous Coronary Intervention/ae [Adverse Effects] | *Myocardial Infarction/th [Therapy] | Myocardial Infarction/mo [Mortality] | Myocardial Infarction/dg [Diagnostic Imaging] | Humans | Hemorrhage/mo [Mortality] | Hemorrhage/et [Etiology] | *Endpoint Determination/st [Standards] | Coronary Thrombosis/mo [Mortality] | Coronary Thrombosis/et [Etiology] | *Coronary Disease/th [Therapy] | Coronary Disease/mo [Mortality] | Coronary Disease/dg [Diagnostic Imaging]Institution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal Article | ReviewOnline resources: Click here to access online Digital Object Identifier: https://dx.doi.org/10.1016/j.jcin.2018.12.031 (Click here) Abbreviated citation: ; JACC Cardiovasc Interv. 12(9):805-819, 2019 05 13.Local Holdings: Available online through MWHC library: 2008 - present.Abstract: Copyright (c) 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.Abstract: 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.

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