Richard Body1,2, Christian Mueller3, Evangelos Giannitsis4, Michael Christ5, Jorge Ordonez-Llanos6, Christopher R de Filippi7, Richard Nowak8, Mauro Panteghini9, Tomas Jernberg10, Mario Plebani11, Franck Verschuren12, John K French13, Robert Christenson14, Silvia Weiser15, Garnet Bendig15, Peter Dilba15, Bertil Lindahl16. 1. Emergency Department, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Sciences Centre, Manchester, United Kingdom. richard.body@manchester.ac.uk. 2. Cardiovascular Sciences Research Group, University of Manchester, Oxford Road, Manchester, United Kingdom. richard.body@manchester.ac.uk. 3. Department of Cardiology, Universitätsspital Basel, Basel, Switzerland. 4. Abteilung Innere Medizin III Kardiologie, Angiologie und Pneumologie, Medizinische Universitätsklinik (Krehl-Linik), Heidelberg, Germany. 5. Klinik für Notfallmedizin und Internistische Intensivmedizine, Klinikum Nürnberg Nord, Nürnberg, Germany. 6. IIB-Hospital de la Santa Creu i Sant Pau and Universitat Autònoma, Barcelona, Spain. 7. Division of Cardiology, University of Maryland, Baltimore, MD. 8. Henry Ford West Bloomfield Hospital, West Bloomfield, MI. 9. Azienda Ospedaliera Luigi Sacco Laboratorio Analisi Chimico Cliniche, Milan, Italy. 10. Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden. 11. Servizio Medicina di Laboratorio Azienda Ospedaliera, Università di Padova Via Giustinianeo, Padova, Italy. 12. Department of Acute Medicine, Cliniques Universitaires St-Luc, Université Catholique de Louvain, Brussels, Belgium. 13. Department of Cardiology, Liverpool Hospital, Liverpool, New South Wales, Australia. 14. University of Maryland School of Medicine, Baltimore, MD. 15. Roche Diagnostics Germany, Penzberg, Germany. 16. Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
Abstract
BACKGROUND: Recent single-center and retrospective studies suggest that acute myocardial infarction (AMI) could be immediately excluded without serial sampling in patients with initial high-sensitivity cardiac troponin T (hs-cTnT) levels below the limit of detection (LoD) of the assay and no electrocardiogram (ECG) ischemia. OBJECTIVE: We aimed to determine the external validity of those findings in a multicenter study at 12 sites in nine countries. METHODS: TRAPID-AMI was a prospective diagnostic cohort study including patients with suspected cardiac chest pain within 6 hours of peak symptoms. Blood drawn on arrival was centrally tested for hs-cTnT (Roche; 99th percentile = 14 ng/L, LoD = 5 ng/L). All patients underwent serial troponin sampling over 4-14 hours. The primary outcome, prevalent AMI, was adjudicated based on sensitive troponin I (Siemens Ultra) levels. Major adverse cardiac events (MACE) including AMI, death, or rehospitalization for acute coronary syndrome with coronary revascularization were determined after 30 days. RESULTS: We included 1,282 patients, of whom 213 (16.6%) had AMI and 231 (18.0%) developed MACE. Of 560 (43.7%) patients with initial hs-cTnT levels below the LoD, four (0.7%) had AMI. In total, 471 (36.7%) patients had both initial hs-cTnT levels below the LoD and no ECG ischemia. These patients had a 0.4% (n = 2) probability of AMI, giving 99.1% (95% confidence interval [CI] = 96.7% to 99.9%) sensitivity and 99.6% (95% CI = 98.5% to 100.0%) negative predictive value. The incidence of MACE in this group was 1.3% (95% CI = 0.5% to 2.8%). CONCLUSIONS: In the absence of ECG ischemia, the detection of very low concentrations of hs-cTnT at admission seems to allow rapid, safe exclusion of AMI in one-third of patients without serial sampling. This could be used alongside careful clinical assessment to help reduce unnecessary hospital admissions.
BACKGROUND: Recent single-center and retrospective studies suggest that acute myocardial infarction (AMI) could be immediately excluded without serial sampling in patients with initial high-sensitivity cardiac troponin T (hs-cTnT) levels below the limit of detection (LoD) of the assay and no electrocardiogram (ECG) ischemia. OBJECTIVE: We aimed to determine the external validity of those findings in a multicenter study at 12 sites in nine countries. METHODS: TRAPID-AMI was a prospective diagnostic cohort study including patients with suspected cardiac chest pain within 6 hours of peak symptoms. Blood drawn on arrival was centrally tested for hs-cTnT (Roche; 99th percentile = 14 ng/L, LoD = 5 ng/L). All patients underwent serial troponin sampling over 4-14 hours. The primary outcome, prevalent AMI, was adjudicated based on sensitive troponin I (Siemens Ultra) levels. Major adverse cardiac events (MACE) including AMI, death, or rehospitalization for acute coronary syndrome with coronary revascularization were determined after 30 days. RESULTS: We included 1,282 patients, of whom 213 (16.6%) had AMI and 231 (18.0%) developed MACE. Of 560 (43.7%) patients with initial hs-cTnT levels below the LoD, four (0.7%) had AMI. In total, 471 (36.7%) patients had both initial hs-cTnT levels below the LoD and no ECG ischemia. These patients had a 0.4% (n = 2) probability of AMI, giving 99.1% (95% confidence interval [CI] = 96.7% to 99.9%) sensitivity and 99.6% (95% CI = 98.5% to 100.0%) negative predictive value. The incidence of MACE in this group was 1.3% (95% CI = 0.5% to 2.8%). CONCLUSIONS: In the absence of ECG ischemia, the detection of very low concentrations of hs-cTnT at admission seems to allow rapid, safe exclusion of AMI in one-third of patients without serial sampling. This could be used alongside careful clinical assessment to help reduce unnecessary hospital admissions.
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