Myocardial Infarction Risk Stratification With a Single Measurement of High-Sensitivity Troponin I.


Journal

Journal of the American College of Cardiology
ISSN: 1558-3597
Titre abrégé: J Am Coll Cardiol
Pays: United States
ID NLM: 8301365

Informations de publication

Date de publication:
23 07 2019
Historique:
received: 16 04 2019
revised: 10 05 2019
accepted: 13 05 2019
entrez: 20 7 2019
pubmed: 20 7 2019
medline: 22 5 2020
Statut: ppublish

Résumé

Limited data exist on rapid risk-stratification strategies using the U.S. Food and Drug Administration-cleared high-sensitivity cardiac troponin I (hs-cTnI) assays. This study sought to examine single measurement hs-cTnI to identify patients at low and high risk for acute myocardial infarction (MI). This was a prospective, multicenter, observational study of patients with suspected acute MI enrolled across 29 U.S. sites with hs-cTnI measured using the Atellica IM TnIH and ADVIA Centaur TNIH (Siemens Healthineers) assays. To identify low-risk patients, sensitivities and negative predictive values (NPVs) for acute MI and MI or death at 30 days were examined across baseline hs-cTnI concentrations. To identify high-risk patients, positive predictive values and specificities for acute MI were evaluated. Among 2,212 patients, acute MI occurred in 12%. The limits of detection or quantitation resulted in excellent sensitivities (range 98.6% to 99.6%) and NPVs (range 99.5% to 99.8%) for acute MI or death at 30 days across both assays. An optimized threshold of <5 ng/l identified almost one-half of all patients as low risk, with sensitivities of 98.6% (95% confidence interval: 97.2% to 100%) and NPVs of 99.6% (95% confidence interval: 99.2% to 99.9%) for acute MI or death at 30 days across both assays. For high-risk patients, hs-cTnI ≥120 ng/l resulted in positive predictive values for acute MI of ≥70%. Recognizing the continuous relationship between baseline hs-cTnI and risk for adverse events, using 2 Food and Drug Administration-cleared hs-cTnI assays, an optimized threshold of <5 ng/l safely identified almost one-half of all patients as low risk at presentation, with hs-cTnI ≥120 ng/l identifying high-risk patients.

Sections du résumé

BACKGROUND
Limited data exist on rapid risk-stratification strategies using the U.S. Food and Drug Administration-cleared high-sensitivity cardiac troponin I (hs-cTnI) assays.
OBJECTIVES
This study sought to examine single measurement hs-cTnI to identify patients at low and high risk for acute myocardial infarction (MI).
METHODS
This was a prospective, multicenter, observational study of patients with suspected acute MI enrolled across 29 U.S. sites with hs-cTnI measured using the Atellica IM TnIH and ADVIA Centaur TNIH (Siemens Healthineers) assays. To identify low-risk patients, sensitivities and negative predictive values (NPVs) for acute MI and MI or death at 30 days were examined across baseline hs-cTnI concentrations. To identify high-risk patients, positive predictive values and specificities for acute MI were evaluated.
RESULTS
Among 2,212 patients, acute MI occurred in 12%. The limits of detection or quantitation resulted in excellent sensitivities (range 98.6% to 99.6%) and NPVs (range 99.5% to 99.8%) for acute MI or death at 30 days across both assays. An optimized threshold of <5 ng/l identified almost one-half of all patients as low risk, with sensitivities of 98.6% (95% confidence interval: 97.2% to 100%) and NPVs of 99.6% (95% confidence interval: 99.2% to 99.9%) for acute MI or death at 30 days across both assays. For high-risk patients, hs-cTnI ≥120 ng/l resulted in positive predictive values for acute MI of ≥70%.
CONCLUSIONS
Recognizing the continuous relationship between baseline hs-cTnI and risk for adverse events, using 2 Food and Drug Administration-cleared hs-cTnI assays, an optimized threshold of <5 ng/l safely identified almost one-half of all patients as low risk at presentation, with hs-cTnI ≥120 ng/l identifying high-risk patients.

Identifiants

pubmed: 31319909
pii: S0735-1097(19)35530-5
doi: 10.1016/j.jacc.2019.05.058
pii:
doi:

Substances chimiques

Troponin I 0

Types de publication

Journal Article Multicenter Study Observational Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

271-282

Commentaires et corrections

Type : CommentIn
Type : CommentIn

Informations de copyright

Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Auteurs

Yader Sandoval (Y)

Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota. Electronic address: https://twitter.com/yadersandoval.

Richard Nowak (R)

Department of Emergency Medicine, Henry Ford Health System, Detroit, Michigan.

Christopher R deFilippi (CR)

Inova Heart and Vascular Institute, Falls Church, Virginia.

Robert H Christenson (RH)

Core Laboratories and Point of Care Services, University of Maryland School of Medicine, Baltimore, Maryland.

W Frank Peacock (WF)

Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas.

James McCord (J)

Heart & Vascular Institute and Department of Internal Medicine, Henry Ford Hospital, Detroit, Michigan.

Alexander T Limkakeng (AT)

Division of Emergency Medicine, Duke University, School of Medicine, Durham, North Carolina.

Anne Sexter (A)

Chronic Disease Research Group, Hennepin Healthcare Research Institute, Minneapolis, Minnesota.

Fred S Apple (FS)

Department of Laboratory Medicine and Pathology, Hennepin Healthcare/Hennepin County Medical Center, Minneapolis, Minnesota; Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota. Electronic address: apple004@umn.edu.

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