Validation of a 0/1 h Algorithm for Rapid Diagnosis of Myocardial Infarction Using a High-Sensitivity Troponin I Assay

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Validation of a 0/1 h Algorithm for Rapid Diagnosis of Myocardial Infarction Using a High-Sensitivity Troponin I Assay. / Lehmacher, Jonas; Toprak, Betül; Sörensen, Nils Arne; Bei der Kellen, Ramona; Goßling, Alina; Hartikainen, Tau Sarra; Haller, Paul Michael; Schock, Alina; Twerenbold, Raphael; Zeller, Tanja; Blankenberg, Stefan; Westermann, Dirk; Neumann, Johannes Tobias.

in: CLIN CHEM, Jahrgang 69, Nr. 5, 28.04.2023, S. 482-491.

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@article{7f281eef6412418ab9a6014d15863769,
title = "Validation of a 0/1 h Algorithm for Rapid Diagnosis of Myocardial Infarction Using a High-Sensitivity Troponin I Assay",
abstract = "BACKGROUND: Current guidelines recommend 0/1 h algorithms using high-sensitivity cardiac troponin (hs-cTn) for fast diagnosis of myocardial infarction (MI). Yet, for some assays, existing data is limited. We aimed to evaluate the diagnostic performance and the prognostic value of a rapid 0/1 h algorithm for the Access hs-cTnI assay.METHODS: In consecutive patients presenting with suspected MI, we measured concentrations of Access hs-cTnI at presentation and after 1 hour. Final diagnosis was adjudicated independently by 2 cardiologists. Parameters for diagnostic performance were calculated, applying the recently derived European Society of Cardiology (ESC) 0/1 h algorithm for Access hs-cTnI. Additionally, we assessed the prognostic utility of Access hs-cTnI for the composite end point of all-cause mortality and incident MI at 3 years.RESULTS: In 1879 patients, 257 non-ST-elevation MIs occurred. Application of the 0/1 h algorithm classified 44.5% as rule-out, 20.3% as rule-in, and triaged 35.1% to the observe group. High rule-out safety was confirmed with a sensitivity of 97.7% (95% CI, 95.0%-99.1%) and a negative predictive value of 99.3% (95% CI, 98.4%-99.7%). Rule-in capacity was moderate with a specificity of 88.0% (95% CI, 86.3%-89.6%) and a positive predictive value of 50.8% (95% CI, 45.7%-55.9%). After exclusion of patients with ST-elevation MI the results showed strong prognostic value, even after adjustment for cardiovascular risk factors and comorbidities, with adjusted hazard ratios of 2.51 (95% CI, 1.56-4.04) in the observe and 3.55 (95% CI, 2.18-5.79) in the rule-in group for the composite end point of all-cause mortality and incident MI at 3 years, compared to ruled-out patients.CONCLUSION: The ESC 0/1 h algorithm for Access hs-cTnI allows safe and efficient triage of patients with suspected MI and has strong prognostic utility up to 3 years after the initial evaluation.",
keywords = "Humans, Troponin I, Biomarkers, Prospective Studies, Myocardial Infarction/diagnosis, Algorithms, Troponin T",
author = "Jonas Lehmacher and Bet{\"u}l Toprak and S{\"o}rensen, {Nils Arne} and {Bei der Kellen}, Ramona and Alina Go{\ss}ling and Hartikainen, {Tau Sarra} and Haller, {Paul Michael} and Alina Schock and Raphael Twerenbold and Tanja Zeller and Stefan Blankenberg and Dirk Westermann and Neumann, {Johannes Tobias}",
note = "{\textcopyright} American Association for Clinical Chemistry 2023. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.",
year = "2023",
month = apr,
day = "28",
doi = "10.1093/clinchem/hvad019",
language = "English",
volume = "69",
pages = "482--491",
journal = "CLIN CHEM",
issn = "0009-9147",
publisher = "American Association for Clinical Chemistry Inc.",
number = "5",

}

RIS

TY - JOUR

T1 - Validation of a 0/1 h Algorithm for Rapid Diagnosis of Myocardial Infarction Using a High-Sensitivity Troponin I Assay

AU - Lehmacher, Jonas

AU - Toprak, Betül

AU - Sörensen, Nils Arne

AU - Bei der Kellen, Ramona

AU - Goßling, Alina

AU - Hartikainen, Tau Sarra

AU - Haller, Paul Michael

AU - Schock, Alina

AU - Twerenbold, Raphael

AU - Zeller, Tanja

AU - Blankenberg, Stefan

AU - Westermann, Dirk

AU - Neumann, Johannes Tobias

N1 - © American Association for Clinical Chemistry 2023. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

PY - 2023/4/28

Y1 - 2023/4/28

N2 - BACKGROUND: Current guidelines recommend 0/1 h algorithms using high-sensitivity cardiac troponin (hs-cTn) for fast diagnosis of myocardial infarction (MI). Yet, for some assays, existing data is limited. We aimed to evaluate the diagnostic performance and the prognostic value of a rapid 0/1 h algorithm for the Access hs-cTnI assay.METHODS: In consecutive patients presenting with suspected MI, we measured concentrations of Access hs-cTnI at presentation and after 1 hour. Final diagnosis was adjudicated independently by 2 cardiologists. Parameters for diagnostic performance were calculated, applying the recently derived European Society of Cardiology (ESC) 0/1 h algorithm for Access hs-cTnI. Additionally, we assessed the prognostic utility of Access hs-cTnI for the composite end point of all-cause mortality and incident MI at 3 years.RESULTS: In 1879 patients, 257 non-ST-elevation MIs occurred. Application of the 0/1 h algorithm classified 44.5% as rule-out, 20.3% as rule-in, and triaged 35.1% to the observe group. High rule-out safety was confirmed with a sensitivity of 97.7% (95% CI, 95.0%-99.1%) and a negative predictive value of 99.3% (95% CI, 98.4%-99.7%). Rule-in capacity was moderate with a specificity of 88.0% (95% CI, 86.3%-89.6%) and a positive predictive value of 50.8% (95% CI, 45.7%-55.9%). After exclusion of patients with ST-elevation MI the results showed strong prognostic value, even after adjustment for cardiovascular risk factors and comorbidities, with adjusted hazard ratios of 2.51 (95% CI, 1.56-4.04) in the observe and 3.55 (95% CI, 2.18-5.79) in the rule-in group for the composite end point of all-cause mortality and incident MI at 3 years, compared to ruled-out patients.CONCLUSION: The ESC 0/1 h algorithm for Access hs-cTnI allows safe and efficient triage of patients with suspected MI and has strong prognostic utility up to 3 years after the initial evaluation.

AB - BACKGROUND: Current guidelines recommend 0/1 h algorithms using high-sensitivity cardiac troponin (hs-cTn) for fast diagnosis of myocardial infarction (MI). Yet, for some assays, existing data is limited. We aimed to evaluate the diagnostic performance and the prognostic value of a rapid 0/1 h algorithm for the Access hs-cTnI assay.METHODS: In consecutive patients presenting with suspected MI, we measured concentrations of Access hs-cTnI at presentation and after 1 hour. Final diagnosis was adjudicated independently by 2 cardiologists. Parameters for diagnostic performance were calculated, applying the recently derived European Society of Cardiology (ESC) 0/1 h algorithm for Access hs-cTnI. Additionally, we assessed the prognostic utility of Access hs-cTnI for the composite end point of all-cause mortality and incident MI at 3 years.RESULTS: In 1879 patients, 257 non-ST-elevation MIs occurred. Application of the 0/1 h algorithm classified 44.5% as rule-out, 20.3% as rule-in, and triaged 35.1% to the observe group. High rule-out safety was confirmed with a sensitivity of 97.7% (95% CI, 95.0%-99.1%) and a negative predictive value of 99.3% (95% CI, 98.4%-99.7%). Rule-in capacity was moderate with a specificity of 88.0% (95% CI, 86.3%-89.6%) and a positive predictive value of 50.8% (95% CI, 45.7%-55.9%). After exclusion of patients with ST-elevation MI the results showed strong prognostic value, even after adjustment for cardiovascular risk factors and comorbidities, with adjusted hazard ratios of 2.51 (95% CI, 1.56-4.04) in the observe and 3.55 (95% CI, 2.18-5.79) in the rule-in group for the composite end point of all-cause mortality and incident MI at 3 years, compared to ruled-out patients.CONCLUSION: The ESC 0/1 h algorithm for Access hs-cTnI allows safe and efficient triage of patients with suspected MI and has strong prognostic utility up to 3 years after the initial evaluation.

KW - Humans

KW - Troponin I

KW - Biomarkers

KW - Prospective Studies

KW - Myocardial Infarction/diagnosis

KW - Algorithms

KW - Troponin T

U2 - 10.1093/clinchem/hvad019

DO - 10.1093/clinchem/hvad019

M3 - SCORING: Journal article

C2 - 36935359

VL - 69

SP - 482

EP - 491

JO - CLIN CHEM

JF - CLIN CHEM

SN - 0009-9147

IS - 5

ER -