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

Publication ,  Journal Article
Spitzer, E; McFadden, E; Vranckx, P; Garcia-Garcia, HM; Seltzer, JH; Held, C; de Vries, T; Menon, V; Brown, KJ; Soliman, OII; Onuma, Y ...
Published in: JACC Cardiovasc Interv
May 13, 2019

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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Published In

JACC Cardiovasc Interv

DOI

EISSN

1876-7605

Publication Date

May 13, 2019

Volume

12

Issue

9

Start / End Page

805 / 819

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Terminology as Topic
  • Stents
  • Risk Factors
  • Risk Assessment
  • Research Design
  • Recurrence
  • Randomized Controlled Trials as Topic
  • Percutaneous Coronary Intervention
 

Citation

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Spitzer, E., McFadden, E., Vranckx, P., Garcia-Garcia, H. M., Seltzer, J. H., Held, C., … Serruys, P. W. (2019). Critical Appraisal of Contemporary Clinical Endpoint Definitions in Coronary Intervention Trials: A Guidance Document. JACC Cardiovasc Interv, 12(9), 805–819. https://doi.org/10.1016/j.jcin.2018.12.031
Spitzer, Ernest, Eugene McFadden, Pascal Vranckx, Hector M. Garcia-Garcia, Jonathan H. Seltzer, Claes Held, Ton de Vries, et al. “Critical Appraisal of Contemporary Clinical Endpoint Definitions in Coronary Intervention Trials: A Guidance Document.JACC Cardiovasc Interv 12, no. 9 (May 13, 2019): 805–19. https://doi.org/10.1016/j.jcin.2018.12.031.
Spitzer E, McFadden E, Vranckx P, Garcia-Garcia HM, Seltzer JH, Held C, et al. Critical Appraisal of Contemporary Clinical Endpoint Definitions in Coronary Intervention Trials: A Guidance Document. JACC Cardiovasc Interv. 2019 May 13;12(9):805–19.
Spitzer, Ernest, et al. “Critical Appraisal of Contemporary Clinical Endpoint Definitions in Coronary Intervention Trials: A Guidance Document.JACC Cardiovasc Interv, vol. 12, no. 9, May 2019, pp. 805–19. Pubmed, doi:10.1016/j.jcin.2018.12.031.
Spitzer E, McFadden E, Vranckx P, Garcia-Garcia HM, Seltzer JH, Held C, de Vries T, Menon V, Brown KJ, Soliman OII, Onuma Y, Lopes RD, Stone GW, Cutlip DE, Serruys PW. Critical Appraisal of Contemporary Clinical Endpoint Definitions in Coronary Intervention Trials: A Guidance Document. JACC Cardiovasc Interv. 2019 May 13;12(9):805–819.
Journal cover image

Published In

JACC Cardiovasc Interv

DOI

EISSN

1876-7605

Publication Date

May 13, 2019

Volume

12

Issue

9

Start / End Page

805 / 819

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Terminology as Topic
  • Stents
  • Risk Factors
  • Risk Assessment
  • Research Design
  • Recurrence
  • Randomized Controlled Trials as Topic
  • Percutaneous Coronary Intervention