Diagnostic discrimination of a novel high-sensitivity cardiac troponin I assay and derivation/validation of an assay-specific 0/1h-algorithm - 08/12/22

Doi : 10.1016/j.ahj.2022.10.007

Luca Koechlin, MD ^a,^b,^c,^{^{1
Drs. Koechlin and Boeddinghaus contributed equally.},}^⁎ , Jasper Boeddinghaus, MD ^a,^c,^d,^e,^{^{1
Drs. Koechlin and Boeddinghaus contributed equally.}}, Pedro Lopez-Ayala, MD ^a,^c, Thomas Nestelberger, MD ^a,^c,^f, Desiree Wussler, MD ^a,^c,^d, Felix Mais ^a,^g, Raphael Twerenbold, MD, Professor ^a,^h, Tobias Zimmermann, MD ^a,^c, Karin Wildi, MD ^a,^c,ⁱ, Anne Marie Köppen ^a, Òscar Miró, MD ^c,^j, F. Javier Martin-Sanchez, MD ^c,^k, Damian Kawecki, MD ^c,^l, Nicolas Geigy, MD ^m, Dagmar I. Keller, MD, Professor ^g, Michael Christ, MD, Professor ⁿ, Andreas Buser, MD, Professor ^o, Maria Rubini Giménez, MD ^a,^p, Luca Bernasconi, Dr. sc. nat. ^q, Angelika Hammerer-Lercher, MD ^q, Christian Mueller, MD ^a,^c,^⁎
for the APACE investigators^{^#}
The collaborators are listed in Appendix.
Jeanne du Fay de Lavallaz, MD PhD ^a,^b, Joan Elias Walter, MD PhD ^a,^b, Michael Freese ^a,^b, Christian Puelacher, MD PhD ^a,^b,^c, Ivo Strebel, PhD ^a,^b, Katharina Rentsch, Prof. Dr. sc. nat ^d, Sandra Mitrovic, PhD ^d, Danielle M. Gualandro, MD ^a,^b, Nicolas Schaerli, MD ^a,^b, Ana Yufera Sanchez, MD ^a,^b, Bernhard Okamura, MD ^a,^b, Samyut Shrestha, MD ^a,^c, Beatriz López, MD ^b,^e, Gemma Martinez-Nadal ^b,^e, Esther Rodriguez Adrada ^f, Jiri Parenica, MD ^j, Arnold von Eckardstein, MD, Professor ^h, Beata Morawiec, MD ^b,ⁱ, Piotr Muzyk, MD ^b,ⁱ
^a Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Basel, Switzerland
^b GREAT network, Basel, Basel, Switzerland
^c Division of Internal Medicine, University Hospital Basel, University of Basel, Basel, Basel, Switzerland
^d Blood Transfusion Centre, Swiss Red Cross, Basel, Switzerland and Department of Hematology, University Hospital Basel, University of Basel, Basel, Basel, Switzerland
^e Emergency Department, Hospital Clinic, Barcelona, Catalonia, Spain
^f Servicio de Urgencias, Hospital Clínico San Carlos, Madrid, Madrid, Spain
^h Emergency Department of Laboratory Medicine, University Hospital Zurich, Zurich, Zurich, Switzerland
ⁱ 2nd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Katowice, Silesian, Poland
^j Department of Cardiology, University Hospital Brno, Brno, Czech Republic and Medical Faculty, Masaryk University, Brno, Moravia, Czech Republic

^a Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Basel, Switzerland
^b Department of Cardiac Surgery, University Hospital Basel, University of Basel, Basel, Basel, Switzerland
^c GREAT network, Basel, Basel, Switzerland
^d Division of Internal Medicine, University Hospital Basel, University of Basel, Basel, Basel, Switzerland
^e BHF/University Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK
^f Division of Cardiology, Vancouver General Hospital, University of British Columbia, Vancouver, British Columbia, Canada
^g Emergency Department, University Hospital Zurich, Zurich, Zurich, Switzerland
^h University Center of Cardiovascular Science & Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany
ⁱ Critical Care Research Group and the University of Queensland, Brisbane, Queensland, Australia
^j Emergency Department, Hospital Clinic, Barcelona, Catalonia, Spain
^k Servicio de Urgencias, Hospital Clínico San Carlos, Madrid, Madrid, Spain
^l 2nd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Katowice, Silesian, Poland
^m Emergency Department, Kantonsspital Liestal, Liestal Liestal, Switzerland
ⁿ Emergency Department, Kantonsspital Luzern, Luzern, Luzern, Switzerland
^o Department of hematology and Blood Bank, University Hospital Basel, University of Basel, Basel, Basel Switzerland
^p Department of Cardiology, Heart Center Leipzig, University of Leipzig, Leipzig, Saxony, Germany
^q Institute of Laboratory Medicine, County Hospital Aarau, Aarau, Aarau, Switzerland

^⁎Reprint requests. Luca Koechlin and Christian Mueller Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Petersgraben 4, CH-4031 Basel, Basel, Switzerland.Cardiovascular Research Institute Basel (CRIB) and Department of CardiologyUniversity Hospital Basel, University of BaselPetersgraben 4, CH-4031BaselBaselSwitzerland

Résumé

Background

We aimed to assess the diagnostic utility of the Dimension EXL LOCI High-Sensitivity Troponin I (hs-cTnI-EXL) assay.

Methods

This multicenter study included patients with chest discomfort presenting to the emergency department. Diagnoses were centrally and independently adjudicated by two cardiologists using all available clinical information. Adjudication was performed twice including serial measurements of high-sensitivity cardiac troponin (hs-cTn) I-Architect (primary analysis) and serial measurements of hs-cTnT-Elecsys (secondary analysis) in addition to the clinically used (hs)-cTn. The primary objective was to assess and compare the discriminatory performance of hs-cTnI-EXL, hs-cTnI-Architect and hs-cTnT-Elecsys for acute myocardial infarction (MI). Furthermore, we derived and validated a hs-cTnI-EXL-specific 0/1h-algorithm.

Results

Adjudicated MI was the diagnosis in 204/1454 (14%) patients. The area under the receiver operating characteristics curve for hs-cTnI-EXL was 0.94 (95%CI, 0.93-0.96), and comparable to hs-cTnI-Architect (0.95; 95%CI, 0.93-0.96) and hs-cTnT-Elecsys (0.93; 95%CI, 0.91-0.95). In the derivation cohort (n = 813), optimal criteria for rule-out of MI were <9ng/L at presentation (if chest pain onset >3h) or <9ng/L and 0h-1h-change <5ng/L, and for rule-in ≥160ng/L at presentation or 0h-1h-change ≥100ng/L. In the validation cohort (n = 345), these cut-offs ruled-out 56% of patients (negative predictive value 99.5% (95%CI, 97.1-99.9), sensitivity 97.8% (95%CI, 88.7-99.6)), and ruled-in 9% (positive predictive value 83.3% (95%CI, 66.4-92.7), specificity 98.3% (95%CI, 96.1-99.3)). Secondary analyses using adjudication based on hs-cTnT measurements confirmed the findings.

Conclusions

The overall performance of the hs-cTnI-EXL was comparable to best-validated hs-cTnT/I assays and an assay-specific 0/1h-algorithm safely rules out and accurately rules in acute MI.

Clinical Trial Registration

ClinicalTrials.gov number, NCT00470587

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Graphical Abstract

Image, graphical abstract

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Abbreviations : AUC, CAD, CI, cTn, CV, ED, ECG, eGFR, ESC, hs-cTn, IQR, LoB, LoD, LoQ, MACE, MI, NPV, PPV, ROC

Plan

Background

Materials and methods

Study design and patient cohort

Adjudication process

Investigational hs-cTn measurements

Secondary objectives: Derivation of an assay-specific hs-cTnI-EXL 0/1h-algorithm and validation

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Vol 255

P. 58-70 - janvier 2023 Retour au numéro

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Diagnostic discrimination of a novel high-sensitivity cardiac troponin I assay and derivation/validation of an assay-specific 0/1h-algorithm - 08/12/22

Résumé

Background

Methods

Results

Conclusions

Clinical Trial Registration

Graphical Abstract

Plan

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