European Society of Cardiology and American College of Cardiology guidelines for redefinition of myocardial infarction

How to use existing assays clinically and for clinical trials

Fred S. Apple, Alan H B Wu, Allan S Jaffe

Research output: Contribution to journalArticle

343 Citations (Scopus)

Abstract

Background: The European Society of Cardiology and American College of Cardiology guidelines for redefinition of myocardial infarction suggest that the cutoff value for diagnosis of acute myocardial infarction (AMI) be the 99th percentile of the reference population at a level measured with imprecision (coefficient of variation) ≤10%. No current commercially available troponin assay meets this requirement. Accordingly, questions have been raised about how to implement cutoff values from the guidelines. The Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluation (COURAGE) trial asked for recommendations concerning the use of troponin assays for the trial. Methods: Cutoff values for the various assays were obtained from package inserts or from direct communication with manufacturers. Results: The cutoff value with ≤10% imprecision was above the 99th percentile of the reference range for all assays. For the present, we suggest that this value be used for clinical and clinical trial purposes. It will account for analytic variability and individual biological changes. We provide recommendations for clinical practice and clinical trials concerning how to make the diagnosis of AMI in patients with ischemic symptoms and patients who undergo percutaneous coronary intervention and coronary artery bypass surgery. Conclusions: This is a first attempt to define cutoff values on the basis of the European Society of Cardiology and American College of Cardiology guidelines. These criteria will provide increased consistency until assays improve to allow full implementation of the guidelines.

Original languageEnglish (US)
Pages (from-to)981-986
Number of pages6
JournalAmerican Heart Journal
Volume144
Issue number6
DOIs
StatePublished - Dec 1 2002

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Myocardial Infarction
Clinical Trials
Guidelines
Troponin
Product Labeling
Drug Evaluation
Percutaneous Coronary Intervention
Coronary Artery Bypass
Reference Values
Communication
Population

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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abstract = "Background: The European Society of Cardiology and American College of Cardiology guidelines for redefinition of myocardial infarction suggest that the cutoff value for diagnosis of acute myocardial infarction (AMI) be the 99th percentile of the reference population at a level measured with imprecision (coefficient of variation) ≤10{\%}. No current commercially available troponin assay meets this requirement. Accordingly, questions have been raised about how to implement cutoff values from the guidelines. The Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluation (COURAGE) trial asked for recommendations concerning the use of troponin assays for the trial. Methods: Cutoff values for the various assays were obtained from package inserts or from direct communication with manufacturers. Results: The cutoff value with ≤10{\%} imprecision was above the 99th percentile of the reference range for all assays. For the present, we suggest that this value be used for clinical and clinical trial purposes. It will account for analytic variability and individual biological changes. We provide recommendations for clinical practice and clinical trials concerning how to make the diagnosis of AMI in patients with ischemic symptoms and patients who undergo percutaneous coronary intervention and coronary artery bypass surgery. Conclusions: This is a first attempt to define cutoff values on the basis of the European Society of Cardiology and American College of Cardiology guidelines. These criteria will provide increased consistency until assays improve to allow full implementation of the guidelines.",
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