Raphael Twerenbold1, Johannes Tobias Neumann2, Nils Arne Sörensen2, Francisco Ojeda3, Mahir Karakas2, Jasper Boeddinghaus4, Thomas Nestelberger4, Patrick Badertscher4, Maria Rubini Giménez4, Christian Puelacher4, Karin Wildi4, Nikola Kozhuharov4, Dominik Breitenbuecher4, Ewelina Biskup4, Jeanne du Fay de Lavallaz4, Dayana Flores4, Desiree Wussler4, Òscar Miró5, F Javier Martín Sánchez6, Beata Morawiec7, Jiri Parenica8, Nicolas Geigy9, Dagmar I Keller10, Tanja Zeller2, Tobias Reichlin4, Stefan Blankenberg2, Dirk Westermann11, Christian Mueller4. 1. Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; Department of General and Interventional Cardiology, University Heart Center Hamburg, University Hospital Hamburg-Eppendorf, Hamburg, Germany. Electronic address: https://twitter.com/RTwerenbold. 2. Department of General and Interventional Cardiology, University Heart Center Hamburg, University Hospital Hamburg-Eppendorf, Hamburg, Germany; German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Luebeck/Kiel, Hamburg, Germany. 3. Department of General and Interventional Cardiology, University Heart Center Hamburg, University Hospital Hamburg-Eppendorf, Hamburg, Germany. 4. Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland. 5. Emergency Department, Hospital Clinic, Barcelona, Catalonia, Spain. 6. Servicio de Urgencias, Hospital Clínico San Carlos, Madrid, Spain. 7. 2nd Department of Cardiology, Medical University of Silesia, Zabrze, Poland. 8. Department of Cardiology, University Hospital Brno, Brno, Czech Republic; Medical Faculty, Masaryk University, Brno, Czech Republic. 9. Emergency Department, Kantonsspital Baselland, Liestal, Switzerland. 10. Emergency Department, University Hospital Zurich, Zurich, Switzerland. 11. Department of General and Interventional Cardiology, University Heart Center Hamburg, University Hospital Hamburg-Eppendorf, Hamburg, Germany; German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Luebeck/Kiel, Hamburg, Germany. Electronic address: d.westermann@uke.de.
Abstract
BACKGROUND: The safety of the European Society of Cardiology (ESC) 0/1-h algorithm for rapid rule-out and rule-in of non-ST-segment elevation myocardial infarction (NSTEMI) using high-sensitivity cardiac troponin (hs-cTn) has been questioned. OBJECTIVES: This study aimed to validate the diagnostic performance of the 0/1-h algorithm in a large multicenter study. METHODS: The authors prospectively enrolled unselected patients in 6 countries presenting to the emergency department with symptoms suggestive of NSTEMI. Final diagnosis was centrally adjudicated by 2 independent cardiologists. Hs-cTnT and hs-cTnI blood concentrations were measured at presentation and after 1 h. Safety of rule-out was quantified by the negative predictive value (NPV) for NSTEMI, accuracy of rule-in by the positive predictive value (PPV), and overall efficacy by the proportion of patients triaged towards rule-out or rule-in within 1 h. RESULTS: Prevalence of NSTEMI was 17%. Among 4,368 patients with serial hs-cTnT measurements available, safety of rule-out (NPV 99.8%, 2,488 of 2,493), accuracy of rule-in (PPV 74.5%, 572 of 768), and overall efficacy were high by assigning three-fourths of patients either to rule-out (57%, 2,493 to 4,368) or rule-in (18%, 768 to 4,368). Similarly, among 3,500 patients with serial hs-cTnI measurements, safety of rule-out (NPV 99.7%, 1,528 of 1,533), accuracy of rule-in (PPV 62.3%, 498 of 800), and overall efficacy were high by assigning more than two-thirds of patients either to rule-out (44%, 1,533 of 3,500) or rule-in (23%, 800 of 3,500). Excellent safety was confirmed in multiple subgroup analyses including patients presenting early (≤3 h) after chest pain onset. CONCLUSIONS: The ESC 0/1-h algorithm using hs-cTnT and hs-cTnI is very safe and effective in triaging patients with suspected NSTEMI. (Advantageous Predictors of Acute Coronary Syndromes Evaluation [APACE]; NCT00470587; and Biomarkers in Acute Cardiac Care [BACC]; NCT02355457).
BACKGROUND: The safety of the European Society of Cardiology (ESC) 0/1-h algorithm for rapid rule-out and rule-in of non-ST-segment elevation myocardial infarction (NSTEMI) using high-sensitivity cardiac troponin (hs-cTn) has been questioned. OBJECTIVES: This study aimed to validate the diagnostic performance of the 0/1-h algorithm in a large multicenter study. METHODS: The authors prospectively enrolled unselected patients in 6 countries presenting to the emergency department with symptoms suggestive of NSTEMI. Final diagnosis was centrally adjudicated by 2 independent cardiologists. Hs-cTnT and hs-cTnI blood concentrations were measured at presentation and after 1 h. Safety of rule-out was quantified by the negative predictive value (NPV) for NSTEMI, accuracy of rule-in by the positive predictive value (PPV), and overall efficacy by the proportion of patients triaged towards rule-out or rule-in within 1 h. RESULTS: Prevalence of NSTEMI was 17%. Among 4,368 patients with serial hs-cTnT measurements available, safety of rule-out (NPV 99.8%, 2,488 of 2,493), accuracy of rule-in (PPV 74.5%, 572 of 768), and overall efficacy were high by assigning three-fourths of patients either to rule-out (57%, 2,493 to 4,368) or rule-in (18%, 768 to 4,368). Similarly, among 3,500 patients with serial hs-cTnI measurements, safety of rule-out (NPV 99.7%, 1,528 of 1,533), accuracy of rule-in (PPV 62.3%, 498 of 800), and overall efficacy were high by assigning more than two-thirds of patients either to rule-out (44%, 1,533 of 3,500) or rule-in (23%, 800 of 3,500). Excellent safety was confirmed in multiple subgroup analyses including patients presenting early (≤3 h) after chest pain onset. CONCLUSIONS: The ESC 0/1-h algorithm using hs-cTnT and hs-cTnI is very safe and effective in triaging patients with suspected NSTEMI. (Advantageous Predictors of Acute Coronary Syndromes Evaluation [APACE]; NCT00470587; and Biomarkers in Acute Cardiac Care [BACC]; NCT02355457).
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Authors: Paul M Haller; Jasper Boeddinghaus; Johannes T Neumann; Nils A Sörensen; Tau S Hartikainen; Alina Goßling; Thomas Nestelberger; Raphael Twerenbold; Jonas Lehmacher; Till Keller; Tanja Zeller; Stefan Blankenberg; Christian Mueller; Dirk Westermann Journal: Diabetes Care Date: 2019-12-16 Impact factor: 17.152
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