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Undetectable Concentrations of a Food and Drug Administration–approved High‐sensitivity Cardiac Troponin T Assay to Rule Out Acute Myocardial Infarction at Emergency Department Arrival

BACKGROUND: The objective of this study was to quantify the sensitivity of very low concentrations of high‐sensitivity cardiac troponin T (hsTnT) at ED arrival for acute myocardial infarction (AMI) in a large cohort of chest pain patients evaluated in real‐world clinical practice. METHODS: This retr...

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Autores principales: McRae, Andrew D., Innes, Grant, Graham, Michelle, Lang, Eddy, Andruchow, James E., Ji, Yunqi, Vatanpour, Shabnam, Abedin, Tasnima, Yang, Hong, Southern, Danielle A., Wang, Dongmei, Seiden‐Long, Isolde, DeKoning, Lawrence, Kavsak, Peter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5656889/
https://www.ncbi.nlm.nih.gov/pubmed/28544100
http://dx.doi.org/10.1111/acem.13229
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author McRae, Andrew D.
Innes, Grant
Graham, Michelle
Lang, Eddy
Andruchow, James E.
Ji, Yunqi
Vatanpour, Shabnam
Abedin, Tasnima
Yang, Hong
Southern, Danielle A.
Wang, Dongmei
Seiden‐Long, Isolde
DeKoning, Lawrence
Kavsak, Peter
author_facet McRae, Andrew D.
Innes, Grant
Graham, Michelle
Lang, Eddy
Andruchow, James E.
Ji, Yunqi
Vatanpour, Shabnam
Abedin, Tasnima
Yang, Hong
Southern, Danielle A.
Wang, Dongmei
Seiden‐Long, Isolde
DeKoning, Lawrence
Kavsak, Peter
author_sort McRae, Andrew D.
collection PubMed
description BACKGROUND: The objective of this study was to quantify the sensitivity of very low concentrations of high‐sensitivity cardiac troponin T (hsTnT) at ED arrival for acute myocardial infarction (AMI) in a large cohort of chest pain patients evaluated in real‐world clinical practice. METHODS: This retrospective study included consecutive ED patients with suspected cardiac chest pain evaluated in four urban EDs, excluding those with ST‐elevation AMI, cardiac arrest or abnormal kidney function. The primary outcomes were AMI at 7, 30, and 90 days. Secondary outcomes included major adverse cardiac events (MACE; all‐cause mortality, AMI, and revascularization) and the individual MACE components. Test characteristics were calculated for hsTnT values from 3 to 200 ng/L . RESULTS: A total of 7,130 patients met inclusion criteria. AMI incidences at 7, 30, and 90 days were 5.8, 6.0, and 6.2%. When the hsTnT assay was performed at ED arrival, the limit of blank of the assay (3 ng/L) ruled out 7‐day AMI in 15.5% of patients with 100% sensitivity and negative predictive value (NPV). The limit of detection of the assay (5 ng/L) ruled out AMI in 33.6% of patients with 99.8% sensitivity and 99.95% NPV for 7‐day AMI. The limit of quantification (the Food and Drug Administration [FDA]‐approved cutoff for lower the reportable limit) of 6 ng/L ruled out AMI in 42.2% of patients with 99.8% sensitivity and 99.95% NPV. The sensitivities of the cutoffs of <3, <5, and <6 ng/L for 7‐day MACE were 99.6, 97.4, and 96.6%, respectively. The NPVs of the cutoffs of <3, <5, and <6 ng/L for 7‐day MACE were 99.8, 99.5, and 99.4%, respectively. A secondary analysis was performed in a subgroup of 3,549 higher‐risk patients who underwent serial troponin testing. In this subgroup, a cutoff of 3 ng/L ruled out 7‐day AMI in 9.6% of patients with 100% sensitivity and NPV, a cutoff of 5 ng/L ruled out 7‐day AMI in 23.3% of patients with 99.7% sensitivity and 99.9% NPV, and a cutoff of 6 ng/L ruled out 7‐day AMI in 29.8% of patients with 99.7 and 99.9% NPV. In the higher‐risk subgroup, the sensitivities of cutoffs of <3, <5, and <6 ng/L for 7‐day MACE were 99.8, 97.4, and 96.6%, respectively. In this higher‐risk subgroup, the NPV of cutoffs of <3, <5, and <6 ng/L for 7‐day MACE were 99.7, 98.5, and 98.4%, respectively. CONCLUSIONS: When used in real‐world clinical practice conditions, hsTnT concentrations < 6 ng/L (below the lower reportable limit for an FDA‐approved assay) at the time of ED arrival can rule out AMI with very high sensitivity and NPV. The sensitivity for MACE is unacceptably low, and thus a single‐troponin rule‐out strategy should only be used in the context of a structured risk evaluation.
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spelling pubmed-56568892017-11-01 Undetectable Concentrations of a Food and Drug Administration–approved High‐sensitivity Cardiac Troponin T Assay to Rule Out Acute Myocardial Infarction at Emergency Department Arrival McRae, Andrew D. Innes, Grant Graham, Michelle Lang, Eddy Andruchow, James E. Ji, Yunqi Vatanpour, Shabnam Abedin, Tasnima Yang, Hong Southern, Danielle A. Wang, Dongmei Seiden‐Long, Isolde DeKoning, Lawrence Kavsak, Peter Acad Emerg Med Original Contributions BACKGROUND: The objective of this study was to quantify the sensitivity of very low concentrations of high‐sensitivity cardiac troponin T (hsTnT) at ED arrival for acute myocardial infarction (AMI) in a large cohort of chest pain patients evaluated in real‐world clinical practice. METHODS: This retrospective study included consecutive ED patients with suspected cardiac chest pain evaluated in four urban EDs, excluding those with ST‐elevation AMI, cardiac arrest or abnormal kidney function. The primary outcomes were AMI at 7, 30, and 90 days. Secondary outcomes included major adverse cardiac events (MACE; all‐cause mortality, AMI, and revascularization) and the individual MACE components. Test characteristics were calculated for hsTnT values from 3 to 200 ng/L . RESULTS: A total of 7,130 patients met inclusion criteria. AMI incidences at 7, 30, and 90 days were 5.8, 6.0, and 6.2%. When the hsTnT assay was performed at ED arrival, the limit of blank of the assay (3 ng/L) ruled out 7‐day AMI in 15.5% of patients with 100% sensitivity and negative predictive value (NPV). The limit of detection of the assay (5 ng/L) ruled out AMI in 33.6% of patients with 99.8% sensitivity and 99.95% NPV for 7‐day AMI. The limit of quantification (the Food and Drug Administration [FDA]‐approved cutoff for lower the reportable limit) of 6 ng/L ruled out AMI in 42.2% of patients with 99.8% sensitivity and 99.95% NPV. The sensitivities of the cutoffs of <3, <5, and <6 ng/L for 7‐day MACE were 99.6, 97.4, and 96.6%, respectively. The NPVs of the cutoffs of <3, <5, and <6 ng/L for 7‐day MACE were 99.8, 99.5, and 99.4%, respectively. A secondary analysis was performed in a subgroup of 3,549 higher‐risk patients who underwent serial troponin testing. In this subgroup, a cutoff of 3 ng/L ruled out 7‐day AMI in 9.6% of patients with 100% sensitivity and NPV, a cutoff of 5 ng/L ruled out 7‐day AMI in 23.3% of patients with 99.7% sensitivity and 99.9% NPV, and a cutoff of 6 ng/L ruled out 7‐day AMI in 29.8% of patients with 99.7 and 99.9% NPV. In the higher‐risk subgroup, the sensitivities of cutoffs of <3, <5, and <6 ng/L for 7‐day MACE were 99.8, 97.4, and 96.6%, respectively. In this higher‐risk subgroup, the NPV of cutoffs of <3, <5, and <6 ng/L for 7‐day MACE were 99.7, 98.5, and 98.4%, respectively. CONCLUSIONS: When used in real‐world clinical practice conditions, hsTnT concentrations < 6 ng/L (below the lower reportable limit for an FDA‐approved assay) at the time of ED arrival can rule out AMI with very high sensitivity and NPV. The sensitivity for MACE is unacceptably low, and thus a single‐troponin rule‐out strategy should only be used in the context of a structured risk evaluation. John Wiley and Sons Inc. 2017-08-11 2017-10 /pmc/articles/PMC5656889/ /pubmed/28544100 http://dx.doi.org/10.1111/acem.13229 Text en © 2017 The Authors. Academic Emergency Medicine published by Wiley Periodicals, Inc. on behalf of Society for Academic Emergency Medicine. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial (http://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Original Contributions
McRae, Andrew D.
Innes, Grant
Graham, Michelle
Lang, Eddy
Andruchow, James E.
Ji, Yunqi
Vatanpour, Shabnam
Abedin, Tasnima
Yang, Hong
Southern, Danielle A.
Wang, Dongmei
Seiden‐Long, Isolde
DeKoning, Lawrence
Kavsak, Peter
Undetectable Concentrations of a Food and Drug Administration–approved High‐sensitivity Cardiac Troponin T Assay to Rule Out Acute Myocardial Infarction at Emergency Department Arrival
title Undetectable Concentrations of a Food and Drug Administration–approved High‐sensitivity Cardiac Troponin T Assay to Rule Out Acute Myocardial Infarction at Emergency Department Arrival
title_full Undetectable Concentrations of a Food and Drug Administration–approved High‐sensitivity Cardiac Troponin T Assay to Rule Out Acute Myocardial Infarction at Emergency Department Arrival
title_fullStr Undetectable Concentrations of a Food and Drug Administration–approved High‐sensitivity Cardiac Troponin T Assay to Rule Out Acute Myocardial Infarction at Emergency Department Arrival
title_full_unstemmed Undetectable Concentrations of a Food and Drug Administration–approved High‐sensitivity Cardiac Troponin T Assay to Rule Out Acute Myocardial Infarction at Emergency Department Arrival
title_short Undetectable Concentrations of a Food and Drug Administration–approved High‐sensitivity Cardiac Troponin T Assay to Rule Out Acute Myocardial Infarction at Emergency Department Arrival
title_sort undetectable concentrations of a food and drug administration–approved high‐sensitivity cardiac troponin t assay to rule out acute myocardial infarction at emergency department arrival
topic Original Contributions
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5656889/
https://www.ncbi.nlm.nih.gov/pubmed/28544100
http://dx.doi.org/10.1111/acem.13229
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