James L Januzzi1, Umesh Sharma2, Pearl Zakroysky3, Quynh A Truong4, Pamela K Woodard5, J Hector Pope6, Thomas Hauser7, Thomas Mayrhofer2, J Toby Nagurney8, David Schoenfeld3, W Frank Peacock9, Jerome L Fleg10, Stephen Wiviott11, Peter S Pang12, James Udelson13, Udo Hoffmann14. 1. Division of Cardiology, Massachusetts General Hospital, Boston, MA. Electronic address: JJanuzzi@partners.org. 2. Department of Radiology, Massachusetts General Hospital, Boston, MA. 3. Department of Biostatistics, Massachusetts General Hospital, Boston, MA. 4. Division of Cardiology, Massachusetts General Hospital, Boston, MA. 5. Mallinkrodt Institute of Radiology, Washington University, St Louis, MO. 6. Department of Emergency Medicine, Baystate Medical Center, Springfield, MA. 7. Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA. 8. Department of Emergency Medicine, Massachusetts General Hospital. 9. Department of Emergency Medicine, Baylor College of Medicine, Boston, MA. 10. Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, MD. 11. Department of Medicine, Brigham and Women's Hospital, Boston, MA. 12. Department of Emergency Medicine, Indiana University, Indianapolis, IN. 13. Department of Medicine, Tufts Medical Center, Boston, MA. 14. Division of Cardiology, Massachusetts General Hospital, Boston, MA; Department of Radiology, Massachusetts General Hospital, Boston, MA.
Abstract
BACKGROUND:Sensitive troponin (Tn) assays have been developed for the evaluation of patients with suspected acute coronary syndrome (ACS). We sought to compare the performance of a commercially available sensitive Tn I (sTnI) and precommercial highly sTnI (hsTnI) method to conventional Tn (cTn) assays. METHODS: Among patients with acute chest pain but normal cTn in the emergency department of 6 centers, sTnI and hsTnI were measured at baseline, 2 and 4 hours after presentation. Diagnostic accuracy of sTnI and hsTnI relative to cTn for diagnosis during index hospitalization as well as their associations with coronary artery disease in patients randomized to coronary computed tomographic angiography (CTA) was assessed. RESULTS: Overall, 322 patients were enrolled, of whom 161 had a CTA; 28 had ACS (8.7%), including 21 with unstable angina pectoris (UAP). Both sTnI and hsTnI values at baseline and second draw had significantly higher sensitivity for ACS and UAP than cTn and had significantly greater area under the receiver operator characteristic curve than cTn at first and second draws. Compared with cTn, 29% of ACS cases previously categorized as UAP were reclassified to acute myocardial infarction with sTnI or hsTnI. An hsTnI below limit of detection had 100% negative predictive value for ACS or significant coronary artery stenosis in those randomized to CTA. CONCLUSIONS: In patients with acute chest discomfort, use of sTnI and hsTnI methods led to significant improvement in the early diagnostic accuracy for ACS, reclassifying one-third of UAP to myocardial infarction. Very low values for hsTnI excluded underlying coronary artery disease.
RCT Entities:
BACKGROUND: Sensitive troponin (Tn) assays have been developed for the evaluation of patients with suspected acute coronary syndrome (ACS). We sought to compare the performance of a commercially available sensitive Tn I (sTnI) and precommercial highly sTnI (hsTnI) method to conventional Tn (cTn) assays. METHODS: Among patients with acute chest pain but normal cTn in the emergency department of 6 centers, sTnI and hsTnI were measured at baseline, 2 and 4 hours after presentation. Diagnostic accuracy of sTnI and hsTnI relative to cTn for diagnosis during index hospitalization as well as their associations with coronary artery disease in patients randomized to coronary computed tomographic angiography (CTA) was assessed. RESULTS: Overall, 322 patients were enrolled, of whom 161 had a CTA; 28 had ACS (8.7%), including 21 with unstable angina pectoris (UAP). Both sTnI and hsTnI values at baseline and second draw had significantly higher sensitivity for ACS and UAP than cTn and had significantly greater area under the receiver operator characteristic curve than cTn at first and second draws. Compared with cTn, 29% of ACS cases previously categorized as UAP were reclassified to acute myocardial infarction with sTnI or hsTnI. An hsTnI below limit of detection had 100% negative predictive value for ACS or significant coronary artery stenosis in those randomized to CTA. CONCLUSIONS: In patients with acute chest discomfort, use of sTnI and hsTnI methods led to significant improvement in the early diagnostic accuracy for ACS, reclassifying one-third of UAP to myocardial infarction. Very low values for hsTnI excluded underlying coronary artery disease.
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