Novel Criteria for the Observe-Zone of the ESC 0/1h-hs-cTnT Algorithm.

Algorithms Cardiac Imaging Techniques / methods Cardiology / methods Cardiovascular System / physiopathology Data Collection Diagnostic Tests, Routine / adverse effects Heart / physiopathology Humans Myocardial Infarction / physiopathology ST Elevation Myocardial Infarction / therapy
NSTEMI algorithms biomarkers myocardial infarction triage troponin troponin T

Journal

Circulation
ISSN: 1524-4539
Titre abrégé: Circulation
Pays: United States
ID NLM: 0147763

Informations de publication

Date de publication:
07 09 2021
Historique:
pubmed: 12 8 2021
medline: 30 12 2021
entrez: 11 8 2021
Statut: ppublish

Résumé

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. 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. 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. 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.

Sections du résumé

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.

Identifiants

DOI: 10.1161/CIRCULATIONAHA.120.052982 PMID: 34376064
pubmed: 34376064
doi: 10.1161/CIRCULATIONAHA.120.052982
doi:

Banques de données

ClinicalTrials.gov
['NCT00470587']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

773-787

Investigateurs

Tobias Zimmermann (T)
Hadrien Schoepfer (H)
Tania Coscia (T)
Valentina Troester (V)
Tobias Reichlin (T)
Marina Kaeslin (M)
Michael Christ (M)
Mario Meier (M)
Patrick Badertscher (P)
Christian Puelacher (C)
Jeanne du Fay de Lavallaz (J)
Eliska Potlukova (E)
Damian Kawecki (D)
Nicolas Geigy (N)
Katharina Rentsch (K)
Samyut Shrestha (S)
Beata Morawiec (B)
Piotr Munzk (P)
Tobias Breidthardt (T)
Michael Freese (M)
Gemma Martinez-Nadal (G)
Carolina Fuenzalida (C)
Sofia Calderón (S)
Esther Rodriguez Adrada (E)
Eva Ganovská (E)
Jiri Parenica (J)
Arnold von Eckardstein (A)
Isabel Campodarve (I)
Joachim Gea (J)
James Mccord (J)
Richard Nowak (R)
Richard Body (R)
Christopher R deFilippi (CR)
Robert H Christenson (RH)
Mauro Panteghini (M)
Mario Plebani (M)
Franck Verschuren (F)
John French (J)
Silvia Weiser (S)
Tomas Jernberg (T)
Aitor Alquezar-Arbe (A)
Jordi Ordonez-Llanos (J)

Commentaires et corrections

Type : ErratumIn

Auteurs

Pedro Lopez-Ayala (P)

Cardiovascular Research Institute Basel and Department of Cardiology (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., S.M., J.W., E.M., R.T., C.M.), University Hospital Basel, University of Basel, Switzerland.
Global Research on Acute Conditions Team Network, Rome, Italy (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., J.W., M.R.G., O.M., B.L.-B., F.J.M.-S., R.T., C.M.).

Thomas Nestelberger (T)

Cardiovascular Research Institute Basel and Department of Cardiology (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., S.M., J.W., E.M., R.T., C.M.), University Hospital Basel, University of Basel, Switzerland.
Global Research on Acute Conditions Team Network, Rome, Italy (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., J.W., M.R.G., O.M., B.L.-B., F.J.M.-S., R.T., C.M.).
Division of Cardiology, Vancouver General Hospital, University of British Columbia, Canada (T.N.).

Jasper Boeddinghaus (J)

Cardiovascular Research Institute Basel and Department of Cardiology (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., S.M., J.W., E.M., R.T., C.M.), University Hospital Basel, University of Basel, Switzerland.
Global Research on Acute Conditions Team Network, Rome, Italy (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., J.W., M.R.G., O.M., B.L.-B., F.J.M.-S., R.T., C.M.).

Luca Koechlin (L)

Cardiovascular Research Institute Basel and Department of Cardiology (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., S.M., J.W., E.M., R.T., C.M.), University Hospital Basel, University of Basel, Switzerland.
Department of Cardiac Surgery (L.K.), University Hospital Basel, University of Basel, Switzerland.
Global Research on Acute Conditions Team Network, Rome, Italy (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., J.W., M.R.G., O.M., B.L.-B., F.J.M.-S., R.T., C.M.).

Paul David Ratmann (PD)

Cardiovascular Research Institute Basel and Department of Cardiology (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., S.M., J.W., E.M., R.T., C.M.), University Hospital Basel, University of Basel, Switzerland.
Global Research on Acute Conditions Team Network, Rome, Italy (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., J.W., M.R.G., O.M., B.L.-B., F.J.M.-S., R.T., C.M.).
ORCID: 0000-0001-9050-1017

Ivo Strebel (I)

Cardiovascular Research Institute Basel and Department of Cardiology (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., S.M., J.W., E.M., R.T., C.M.), University Hospital Basel, University of Basel, Switzerland.
Global Research on Acute Conditions Team Network, Rome, Italy (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., J.W., M.R.G., O.M., B.L.-B., F.J.M.-S., R.T., C.M.).
ORCID: 0000-0001-9976-4112

Juliane Gehrke (J)

Cardiovascular Research Institute Basel and Department of Cardiology (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., S.M., J.W., E.M., R.T., C.M.), University Hospital Basel, University of Basel, Switzerland.
Global Research on Acute Conditions Team Network, Rome, Italy (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., J.W., M.R.G., O.M., B.L.-B., F.J.M.-S., R.T., C.M.).
ORCID: 0000-0003-1963-9632

Severin Meier (S)

Cardiovascular Research Institute Basel and Department of Cardiology (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., S.M., J.W., E.M., R.T., C.M.), University Hospital Basel, University of Basel, Switzerland.

Joan Walter (J)

Cardiovascular Research Institute Basel and Department of Cardiology (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., S.M., J.W., E.M., R.T., C.M.), University Hospital Basel, University of Basel, Switzerland.
Global Research on Acute Conditions Team Network, Rome, Italy (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., J.W., M.R.G., O.M., B.L.-B., F.J.M.-S., R.T., C.M.).
Institute of Diagnostic and Interventional Radiology (J.W.), University Hospital Zurich, Switzerland.

Maria Rubini Gimenez (M)

Global Research on Acute Conditions Team Network, Rome, Italy (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., J.W., M.R.G., O.M., B.L.-B., F.J.M.-S., R.T., C.M.).
Cardiology Department, Herzzentrum Leipzig, Germany (M.R.G.).

Eugenio Mutschler (E)

Cardiovascular Research Institute Basel and Department of Cardiology (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., S.M., J.W., E.M., R.T., C.M.), University Hospital Basel, University of Basel, Switzerland.

Òscar Miró (Ò)

Global Research on Acute Conditions Team Network, Rome, Italy (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., J.W., M.R.G., O.M., B.L.-B., F.J.M.-S., R.T., C.M.).
Emergency Department, Hospital Clinic, University of Barcelona, Spain (O.M., B.L.-B.).
ORCID: 0000-0002-7924-9751

Beatriz López-Barbeito (B)

Global Research on Acute Conditions Team Network, Rome, Italy (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., J.W., M.R.G., O.M., B.L.-B., F.J.M.-S., R.T., C.M.).
Emergency Department, Hospital Clinic, University of Barcelona, Spain (O.M., B.L.-B.).

Francisco Javier Martín-Sánchez (FJ)

Global Research on Acute Conditions Team Network, Rome, Italy (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., J.W., M.R.G., O.M., B.L.-B., F.J.M.-S., R.T., C.M.).
Emergency Department, Hospital Clínico San Carlos, Madrid, Spain (F.J.M.-S., E.R.-A.).

Esther Rodríguez-Adrada (E)

Emergency Department, Hospital Clínico San Carlos, Madrid, Spain (F.J.M.-S., E.R.-A.).

Dagmar I Keller (DI)

Emergency Department (D.I.K.), University Hospital Zurich, Switzerland.

L Kristin Newby (LK)

Division of Cardiology, Department of Medicine and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (L.K.N.).
ORCID: 0000-0002-6394-8187

Raphael Twerenbold (R)

Cardiovascular Research Institute Basel and Department of Cardiology (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., S.M., J.W., E.M., R.T., C.M.), University Hospital Basel, University of Basel, Switzerland.
Global Research on Acute Conditions Team Network, Rome, Italy (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., J.W., M.R.G., O.M., B.L.-B., F.J.M.-S., R.T., C.M.).
University Center of Cardiovascular Science and Department of Cardiology, University Heart and Vascular Center Hamburg, Germany (R.T.).

Evangelos Giannitsis (E)

Department of Medicine III, University Hospital Heidelberg, Germany (E.G.).

Bertil Lindahl (B)

Department of Medical Sciences, Uppsala University, Sweden (B.L.).
Uppsala Clinical Research Center, Sweden (B.L.).

Christian Mueller (C)

Cardiovascular Research Institute Basel and Department of Cardiology (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., S.M., J.W., E.M., R.T., C.M.), University Hospital Basel, University of Basel, Switzerland.
Global Research on Acute Conditions Team Network, Rome, Italy (P.L.-A., T.N., J.B., L.K., P.D.R., I.S., J.G., J.W., M.R.G., O.M., B.L.-B., F.J.M.-S., R.T., C.M.).
ORCID: 0000-0002-1120-6405

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Classifications MeSH

questionsmedicales.fr › Sciences de l'information › Méthodologies informatiques › Algorithmes › Novel Criteria for the Observe-Zone of the ESC...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Imagerie diagnostique › Techniques d'imagerie cardiaque › Novel Criteria for the Observe-Zone of the ESC...
questionsmedicales.fr › Professions de santé › Médecine › Médecine interne › Cardiologie › Novel Criteria for the Observe-Zone of the ESC...
questionsmedicales.fr › Système cardiovasculaire › Novel Criteria for the Observe-Zone of the ESC...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Collecte de données › Novel Criteria for the Observe-Zone of the ESC...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Tests diagnostiques courants › Novel Criteria for the Observe-Zone of the ESC...
questionsmedicales.fr › Système cardiovasculaire › Coeur › Novel Criteria for the Observe-Zone of the ESC...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Novel Criteria for the Observe-Zone of the ESC...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Nécrose › Infarctus › Infarctus du myocarde › Novel Criteria for the Observe-Zone of the ESC...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Nécrose › Infarctus › Infarctus du myocarde › Infarctus du myocarde avec sus-décalage du segment ST › Novel Criteria for the Observe-Zone of the ESC...