Novel Criteria for the Observe-Zone of the ESC 0/1h-hs-cTnT Algorithm
BACKGROUND: The non-ST-segment-elevation myocardial infarction (NSTEMI) guidelines of the European Society of Cardiology (ESC) recommend a 3h cardiac troponin determination in patients triaged to the observe-zone of the ESC 0/1h-algorithm; however, no specific cutoff for further triage is endorsed. Recently, a specific cutoff for 0/3h high-sensitivity cardiac troponin T (hs-cTnT) change (7 ng/L) was proposed, warranting external validation.
METHODS: Patients presenting with acute chest discomfort to the emergency department were prospectively enrolled into an international multicenter diagnostic study. Final diagnoses were centrally adjudicated by 2 independent cardiologists applying the fourth universal definition of myocardial infarction, on the basis of complete cardiac workup, cardiac imaging, and serial hs-cTnT. Hs-cTnT concentrations were measured at presentation, after 1 hour, and after 3 hours. The objective was to externally validate the proposed cutoff, and if necessary, derive and internally as well as externally validate novel 0/3h-criteria for the observe-zone of the ESC 0/1h-hs-cTnT-algorithm in an independent multicenter cohort.
RESULTS: Among 2076 eligible patients, application of the ESC 0/1h-hs-cTnT-algorithm triaged 1512 patients (72.8%) to either rule out or rule in NSTEMI, leaving 564 patients (27.2%) in the observe-zone (adjudicated NSTEMI prevalence, 120/564 patients, 21.3%). The suggested 0/3h-hs-cTnT-change of <7 ng/L triaged 517 patients (91.7%) toward rule-out, resulting in a sensitivity of 33.3% (95% CI, 25.5-42.2), missing 80 patients with NSTEMI, and ≥7 ng/L triaged 47 patients toward rule-in (8.3%), resulting in a specificity of 98.4% (95% CI, 96.8-99.2). Novel derived 0/3h-criteria for the observe-zone patients ruled out NSTEMI with a 3h hs-cTnT concentration <15 ng/L and a 0/3h-hs-cTnT absolute change <4 ng/L, triaging 138 patients (25%) toward rule-out, resulting in a sensitivity of 99.2% (95% CI, 96.0-99.9), missing 1 patient with NSTEMI. A 0/3h-hs-cTnT absolute change ≥6 ng/L triaged 63 patients (11.2%) toward rule-in, resulting in a specificity of 98% (95% CI, 96.2-98.9) Thereby, the novel 0/3h-criteria reduced the number of patients in the observe zone by 36%s and the number of type 1 myocardial infarction by 50%. Findings were confirmed in both internal and external validation.
CONCLUSIONS: A combination of a 3h-hs-cTnT concentration (<15 ng/L) and a 0/3h absolute change (<4 ng/L) is necessary to safely rule out NSTEMI in patients remaining in the observe-zone of the ESC 0/1h-hs-cTnT-algorithm. Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT00470587.
| Errataetall: |
ErratumIn: Circulation. 2021 Dec 7;144(23):e488. - PMID 34871114 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:144 |
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| Enthalten in: |
Circulation - 144(2021), 10 vom: 07. Sept., Seite 773-787 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Lopez-Ayala, Pedro [VerfasserIn] |
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| Links: |
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| Themen: |
Algorithms |
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| Anmerkungen: |
Date Completed 29.12.2021 Date Revised 29.12.2021 published: Print-Electronic ClinicalTrials.gov: NCT00470587 ErratumIn: Circulation. 2021 Dec 7;144(23):e488. - PMID 34871114 Citation Status MEDLINE |
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| doi: |
10.1161/CIRCULATIONAHA.120.052982 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM329200844 |
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| 500 | |a ErratumIn: Circulation. 2021 Dec 7;144(23):e488. - PMID 34871114 | ||
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| 520 | |a BACKGROUND: The non-ST-segment-elevation myocardial infarction (NSTEMI) guidelines of the European Society of Cardiology (ESC) recommend a 3h cardiac troponin determination in patients triaged to the observe-zone of the ESC 0/1h-algorithm; however, no specific cutoff for further triage is endorsed. Recently, a specific cutoff for 0/3h high-sensitivity cardiac troponin T (hs-cTnT) change (7 ng/L) was proposed, warranting external validation | ||
| 520 | |a METHODS: Patients presenting with acute chest discomfort to the emergency department were prospectively enrolled into an international multicenter diagnostic study. Final diagnoses were centrally adjudicated by 2 independent cardiologists applying the fourth universal definition of myocardial infarction, on the basis of complete cardiac workup, cardiac imaging, and serial hs-cTnT. Hs-cTnT concentrations were measured at presentation, after 1 hour, and after 3 hours. The objective was to externally validate the proposed cutoff, and if necessary, derive and internally as well as externally validate novel 0/3h-criteria for the observe-zone of the ESC 0/1h-hs-cTnT-algorithm in an independent multicenter cohort | ||
| 520 | |a RESULTS: Among 2076 eligible patients, application of the ESC 0/1h-hs-cTnT-algorithm triaged 1512 patients (72.8%) to either rule out or rule in NSTEMI, leaving 564 patients (27.2%) in the observe-zone (adjudicated NSTEMI prevalence, 120/564 patients, 21.3%). The suggested 0/3h-hs-cTnT-change of <7 ng/L triaged 517 patients (91.7%) toward rule-out, resulting in a sensitivity of 33.3% (95% CI, 25.5-42.2), missing 80 patients with NSTEMI, and ≥7 ng/L triaged 47 patients toward rule-in (8.3%), resulting in a specificity of 98.4% (95% CI, 96.8-99.2). Novel derived 0/3h-criteria for the observe-zone patients ruled out NSTEMI with a 3h hs-cTnT concentration <15 ng/L and a 0/3h-hs-cTnT absolute change <4 ng/L, triaging 138 patients (25%) toward rule-out, resulting in a sensitivity of 99.2% (95% CI, 96.0-99.9), missing 1 patient with NSTEMI. A 0/3h-hs-cTnT absolute change ≥6 ng/L triaged 63 patients (11.2%) toward rule-in, resulting in a specificity of 98% (95% CI, 96.2-98.9) Thereby, the novel 0/3h-criteria reduced the number of patients in the observe zone by 36%s and the number of type 1 myocardial infarction by 50%. Findings were confirmed in both internal and external validation | ||
| 520 | |a CONCLUSIONS: A combination of a 3h-hs-cTnT concentration (<15 ng/L) and a 0/3h absolute change (<4 ng/L) is necessary to safely rule out NSTEMI in patients remaining in the observe-zone of the ESC 0/1h-hs-cTnT-algorithm. Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT00470587 | ||
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| 650 | 4 | |a NSTEMI | |
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| 650 | 4 | |a biomarkers | |
| 650 | 4 | |a myocardial infarction | |
| 650 | 4 | |a triage | |
| 650 | 4 | |a troponin | |
| 650 | 4 | |a troponin T | |
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| 700 | 1 | |a Boeddinghaus, Jasper |e verfasserin |4 aut | |
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| 700 | 1 | |a Ratmann, Paul David |e verfasserin |4 aut | |
| 700 | 1 | |a Strebel, Ivo |e verfasserin |4 aut | |
| 700 | 1 | |a Gehrke, Juliane |e verfasserin |4 aut | |
| 700 | 1 | |a Meier, Severin |e verfasserin |4 aut | |
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| 700 | 1 | |a Rubini Gimenez, Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Mutschler, Eugenio |e verfasserin |4 aut | |
| 700 | 1 | |a Miró, Òscar |e verfasserin |4 aut | |
| 700 | 1 | |a López-Barbeito, Beatriz |e verfasserin |4 aut | |
| 700 | 1 | |a Martín-Sánchez, Francisco Javier |e verfasserin |4 aut | |
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| 700 | 1 | |a Keller, Dagmar I |e verfasserin |4 aut | |
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| 700 | 1 | |a Giannitsis, Evangelos |e verfasserin |4 aut | |
| 700 | 1 | |a Lindahl, Bertil |e verfasserin |4 aut | |
| 700 | 1 | |a Mueller, Christian |e verfasserin |4 aut | |
| 700 | 0 | |a APACE and TRAPID-AMI Investigators† |e verfasserin |4 aut | |
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| 700 | 1 | |a Troester, Valentina |e investigator |4 oth | |
| 700 | 1 | |a Reichlin, Tobias |e investigator |4 oth | |
| 700 | 1 | |a Kaeslin, Marina |e investigator |4 oth | |
| 700 | 1 | |a Christ, Michael |e investigator |4 oth | |
| 700 | 1 | |a Meier, Mario |e investigator |4 oth | |
| 700 | 1 | |a Badertscher, Patrick |e investigator |4 oth | |
| 700 | 1 | |a Puelacher, Christian |e investigator |4 oth | |
| 700 | 1 | |a du Fay de Lavallaz, Jeanne |e investigator |4 oth | |
| 700 | 1 | |a Potlukova, Eliska |e investigator |4 oth | |
| 700 | 1 | |a Kawecki, Damian |e investigator |4 oth | |
| 700 | 1 | |a Geigy, Nicolas |e investigator |4 oth | |
| 700 | 1 | |a Rentsch, Katharina |e investigator |4 oth | |
| 700 | 1 | |a Shrestha, Samyut |e investigator |4 oth | |
| 700 | 1 | |a Morawiec, Beata |e investigator |4 oth | |
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