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Critical Appraisal of Contemporary Clinical Endpoint Definitions in Coronary Intervention Trials: A Guidance Document. [Review]

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Citation: Jacc: Cardiovascular Interventions. 12(9):805-819, 2019 05 13.PMID: 31072504Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | ReviewSubject headings: *Coronary Disease/th [Therapy] | *Endpoint Determination/st [Standards] | *Myocardial Infarction/th [Therapy] | *Percutaneous Coronary Intervention/st [Standards] | *Randomized Controlled Trials as Topic/st [Standards] | *Research Design/st [Standards] | Coronary Angiography/st [Standards] | Coronary Disease/dg [Diagnostic Imaging] | Coronary Disease/mo [Mortality] | Coronary Thrombosis/et [Etiology] | Coronary Thrombosis/mo [Mortality] | Hemorrhage/et [Etiology] | Hemorrhage/mo [Mortality] | Humans | Myocardial Infarction/dg [Diagnostic Imaging] | Myocardial Infarction/mo [Mortality] | Percutaneous Coronary Intervention/ae [Adverse Effects] | Percutaneous Coronary Intervention/is [Instrumentation] | Percutaneous Coronary Intervention/mo [Mortality] | Recurrence | Risk Assessment | Risk Factors | Stents/st [Standards] | Terminology as Topic | Time Factors | Treatment OutcomeYear: 2019 Local holdings: Available online through MWHC library: 2008 - presentISSN:

1936-8798

Name of journal: JACC. Cardiovascular interventionsAbstract: Copyright (c) 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.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.All authors: 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 POriginally published: Jacc: Cardiovascular Interventions. 12(9):805-819, 2019 May 13.Fiscal year: FY2019Digital Object Identifier:

https://dx.doi.org/10.1016/j.jcin.2018.12.031

Date added to catalog: 2019-05-21

Holdings ( 1 )
Title notes ( 4 )

Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article	31072504	Available		31072504

Available online through MWHC library: 2008 - present

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.

English