Original Investigation
Early Diagnosis of Myocardial Infarction With Point-of-Care High-Sensitivity Cardiac Troponin I

https://doi.org/10.1016/j.jacc.2019.12.065Get rights and content
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Abstract

Background

Until now, high-sensitivity cardiac troponin (hs-cTn) assays were mainly developed for large central laboratory platforms.

Objectives

This study aimed to assess the clinical performance of a point-of-care (POC)-hs-cTnI assay in patients with suspected myocardial infarction (MI).

Methods

This study enrolled patients presenting to the emergency department with symptoms suggestive of MI. Two cardiologists centrally adjudicated the final diagnosis using all clinical data including cardiac imaging. The primary objective was to directly compare diagnostic accuracy of POC-hs-cTnI-TriageTrue versus best-validated central laboratory assays. Secondary objectives included the derivation and validation of a POC-hs-cTnI-TriageTrue–specific 0/1-h algorithm.

Results

MI was the adjudicated final diagnosis in 178 of 1,261 patients (14%). The area under the curve (AUC) for POC-hs-cTnI-TriageTrue at presentation was 0.95 (95% confidence interval [CI]: 0.93 to 0.96) and was at least comparable to hs-cTnT-Elecsys (AUC: 0.94; 95% CI: 0.93 to 0.96; p = 0.213) and hs-cTnI-Architect (AUC: 0.92; 95% CI: 0.90 to 0.93; p < 0.001). A single cutoff concentration <3 ng/l at presentation identified 45% of patients at low risk with a negative predictive value (NPV) of 100% (95% CI: 99.4% to 100%). A single cutoff concentration >60 ng/l identified patients at high risk with a positive predictive value (PPV) of 76.8% (95% CI: 68.9% to 83.6%). The 0/1-h algorithm ruled out 55% of patients (NPV: 100%; 95% CI: 98.8% to 100%), and ruled in 18% of patients (PPV: 76.8%; 95% CI: 67.2% to 84.7%). Ruled-out patients had cumulative event rates of 0% at 30 days and 1.6% at 2 years. This study confirmed these findings in a secondary analysis including hs-cTnI-Architect for central adjudication.

Conclusions

The POC-hs-cTnI-TriageTrue assay provides high diagnostic accuracy in patients with suspected MI with a clinical performance that is at least comparable to that of best-validated central laboratory assays. (Advantageous Predictors of Acute Coronary Syndromes Evaluation Study [APACE]; NCT00470587)

Key Words

0/1-h algorithm
diagnosis of myocardial infarction
guidelines
high-sensitivity cardiac troponin I
point of care
rule in
rule out

Abbreviations and Acronyms

AUC
area under the curve
CI
confidence interval
cTn
cardiac troponin
cTnT/I
cardiac troponin T and/or I
CV
coefficient of variation
ED
emergency department
ESC
European Society of Cardiology
hs-cTn
high-sensitivity cardiac troponin
IQR
interquartile range
MI
myocardial infarction
NPV
negative predictive value
POC
point-of-care
PPV
positive predictive value

Cited by (0)

The study was supported by research grants from the Swiss National Science Foundation, the Swiss Heart Foundation, the Kommission für Technologie und Innovation, the European Union, the Stiftung für Kardiovaskuläre Forschung Basel, the University of Basel, the University Hospital Basel, Abbott, Beckman Coulter, Biomerieux, Roche, Ortho Clinical Diagnostics, Quidel, Siemens, and Singulex. The sponsors had no role in designing or conducting the study and no role in gathering or analyzing the data or writing the manuscript. Furthermore, the high-sensitivity cardiac troponin assays investigated were donated by the manufacturers, who had no role in the design of the study, the analysis of the data, the preparation of the manuscript, or the decision to submit the manuscript for publication. Dr. Boeddinghaus has received research grants from the University of Basel, the University Hospital of Basel and the Division of Internal Medicine, the Swiss Academy of Medical Sciences, and the Gottfried and Julia Bangerter-Rhyner-Foundation; and has received speaker honoraria and/or consulting honoraria from Siemens, Roche Diagnostics, Ortho Clinical Diagnostics, and Quidel Corporation. Dr. Nestelberger has received speaker honoraria and/or consulting honoraria from Beckman Coulter. Dr. Koechlin has received a research grant from the University of Basel, the Swiss Academy of Medical Sciences, and the Gottfried and Julia Bangerter-Rhyner Foundation, as well as the Freiwillige Akademische Gesellschaft (FAG) Basel. Dr. Walter has received research grants from the Swiss Academy of Medical Sciences, the Gottfried and Julia Bangerter-Rhyner Foundation, and the Swiss Heart Foundation. Dr. Zimmermann received research support from the FAG Basel. Dr. Badertscher has received research funding from the Stiftung für Herzschrittmacher und Elektrophysiologie, the FAG Basel, and from the University of Basel. Dr. Wildi has received research grants from the FAG Basel, the Gottfried and Julia Bangerter-Rhyner Foundation, and the Prince Charles Hospital Foundation; and has received a PhD scholarship from the University of Queensland. Dr. Rubini Gimenez has received research grants from the Swiss National Science Foundation (P400PM_180828), the Swiss Heart Foundation, and the Women and Heart Foundation; and has received speaker honoraria from Abbott, Roche, Siemens, and Ortho Clinical Diagnostics. Dr. Gualandro has received consulting honoraria outside of the submitted work from Roche. Dr. Twerenbold has received research support from the Swiss National Science Foundation (P300PB_167803), the Swiss Heart Foundation, the Swiss Society of Cardiology, the University Hospital of Basel, the University of Basel, and the Cardiovascular Research Foundation Basel; and has received speaker honoraria and/or consulting honoraria from Abbott, Amgen, Brahms, Roche, Singulex, and Siemens. Dr. Mueller has received research support from the Swiss National Science Foundation, the Swiss Heart Foundation, the Kommission für Technologie und Innovation, the Stiftung für Kardiovaskuläre Forschung Basel, the University of Basel, Abbott, AstraZeneca, Beckman Coulter, Biomerieux, Brahms, Ortho Clinical Diagnostics, Roche, Siemens, Singulex, Sphingotec, and the University Hospital Basel; and has received speaker honoraria and/or consulting honoraria from Abbott, Amgen, AstraZeneca, Biomerieux, Boehringer Ingelheim, Bristol-Myers Squibb, Brahms, Cardiorentis, Novartis, Roche, Sanofi, Siemens, and Singulex. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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∗

Drs. Boeddinghaus and Nestelberger have contributed equally and should be considered joint first authors.

© 2020 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.