Yader Sandoval1, Bradley R Lewis2, Ramila A Mehta3, Olatunde Ola4,5, Jonathan D Knott6, Laura De Michieli1,7, Ashok Akula4,5, Ronstan Lobo1, Eric H Yang8, S Michael Gharacholou9, Marshall Dworak10, Erika Crockford11, Nicholas Rastas10, Eric Grube12, Swetha Karturi4, Scott Wohlrab13, David O Hodge14, Tahir Tak10, Charles Cagin10, Rajiv Gulati1, Allan S Jaffe1,15. 1. Department of Cardiovascular Diseases (Y.L., L.D.M., R.L., R.G., A.S.J.), Mayo Clinic, Rochester, MN. 2. Division of Biomedical Statistics and Informatics (B.R.L.), Mayo Clinic, Rochester, MN. 3. Department of Health Sciences Research (R.A.M.), Mayo College of Medicine, Rochester, MN. 4. Division of Hospital Internal Medicine (O.O., A.A., S.K..), Mayo Clinic Health System, La Crosse, WI. 5. Center for Clinical and Translational Science, Mayo Clinic Graduate School of Biomedical Sciences, Rochester MN (O.O., A.A.). 6. Department of Internal Medicine (J.D.K.), Mayo Clinic, Rochester, MN. 7. Department of Cardiac, Thoracic and Vascular Sciences and Public Health, University of Padova, Italy (L.D.M.). 8. Department of Cardiovascular Diseases, Mayo Clinic, Phoenix, AZ (E.H.Y.). 9. Department of Cardiovascular Diseases, Mayo Clinic, Jacksonville, FL (S.M.G.). 10. Department of Cardiovascular Diseases (M.D., N.R., T.T., C.C.), Mayo Clinic Health System, La Crosse, WI. 11. Department of Family Medicine (E.C.), Mayo Clinic Health System, La Crosse, WI. 12. Department of Emergency Medicine (E.G.), Mayo Clinic Health System, La Crosse, WI. 13. Department of Laboratory Medicine and Pathology (S.W.), Mayo Clinic Health System, La Crosse, WI. 14. Department of Health Sciences Research, Mayo College of Medicine, Jacksonville, FL (D.O.H.). 15. Department of Laboratory Medicine and Pathology (A.S.J.), Mayo Clinic, Rochester, MN.
Abstract
BACKGROUND: There are good data to support using a single high-sensitivity cardiac troponin T (hs-cTnT) below the limit of detection of 5 ng/L to exclude acute myocardial infarction. Per the US Food and Drug Administration, hs-cTnT can only report to the limit of quantitation of 6 ng/L, a threshold for which there are limited data. Our goal was to determine whether a single hs-cTnT below the limit of quantitation of 6 ng/L is a safe strategy to identify patients at low risk for acute myocardial injury and infarction. METHODS: The efficacy (proportion identified as low risk based on baseline hs-cTnT<6 ng/L) of identifying low-risk patients was examined in a multicenter (n=22 sites) US cohort study of emergency department patients undergoing at least 1 hs-cTnT (CV Data Mart Biomarker cohort). We then determined the performance of a single hs-cTnT<6 ng/L (biomarker alone) to exclude acute myocardial injury (subsequent hs-cTnT >99th percentile in those with an initial hs-cTnT<6 ng/L). The clinically intended rule-out strategy combining a nonischemic ECG with a baseline hs-cTnT<6 ng/L was subsequently tested in an adjudicated cohort in which the diagnostic performance for ruling out acute myocardial infarction and safety (myocardial infarction or death at 30 days) were evaluated. RESULTS: A total of 85 610 patients were evaluated in the CV Data Mart Biomarker cohort, among which 24 646 (29%) had a baseline hs-cTnT<6 ng/L. Women were more likely than men to have hs-cTnT<6 ng/L (38% versus 20%, P<0.0001). Among 11 962 patients with baseline hs-cTnT<6 ng/L and serial measurements, only 1.2% developed acute myocardial injury, resulting in a negative predictive value of 98.8% (95% CI, 98.6-99.0) and sensitivity of 99.6% (95% CI, 99.5-99.6). In the adjudicated cohort, a nonischemic ECG with hs-cTnT<6 ng/L identified 33% of patients (610/1849) as low risk and resulted in a negative predictive value and sensitivity of 100% and a 30-day rate of 0.2% for myocardial infarction or death. CONCLUSIONS: A single hs-cTnT below the limit of quantitation of 6 ng/L is a safe and rapid method to identify a substantial number of patients at very low risk for acute myocardial injury and infarction.
BACKGROUND: There are good data to support using a single high-sensitivity cardiac troponin T (hs-cTnT) below the limit of detection of 5 ng/L to exclude acute myocardial infarction. Per the US Food and Drug Administration, hs-cTnT can only report to the limit of quantitation of 6 ng/L, a threshold for which there are limited data. Our goal was to determine whether a single hs-cTnT below the limit of quantitation of 6 ng/L is a safe strategy to identify patients at low risk for acute myocardial injury and infarction. METHODS: The efficacy (proportion identified as low risk based on baseline hs-cTnT<6 ng/L) of identifying low-risk patients was examined in a multicenter (n=22 sites) US cohort study of emergency department patients undergoing at least 1 hs-cTnT (CV Data Mart Biomarker cohort). We then determined the performance of a single hs-cTnT<6 ng/L (biomarker alone) to exclude acute myocardial injury (subsequent hs-cTnT >99th percentile in those with an initial hs-cTnT<6 ng/L). The clinically intended rule-out strategy combining a nonischemic ECG with a baseline hs-cTnT<6 ng/L was subsequently tested in an adjudicated cohort in which the diagnostic performance for ruling out acute myocardial infarction and safety (myocardial infarction or death at 30 days) were evaluated. RESULTS: A total of 85 610 patients were evaluated in the CV Data Mart Biomarker cohort, among which 24 646 (29%) had a baseline hs-cTnT<6 ng/L. Women were more likely than men to have hs-cTnT<6 ng/L (38% versus 20%, P<0.0001). Among 11 962 patients with baseline hs-cTnT<6 ng/L and serial measurements, only 1.2% developed acute myocardial injury, resulting in a negative predictive value of 98.8% (95% CI, 98.6-99.0) and sensitivity of 99.6% (95% CI, 99.5-99.6). In the adjudicated cohort, a nonischemic ECG with hs-cTnT<6 ng/L identified 33% of patients (610/1849) as low risk and resulted in a negative predictive value and sensitivity of 100% and a 30-day rate of 0.2% for myocardial infarction or death. CONCLUSIONS: A single hs-cTnT below the limit of quantitation of 6 ng/L is a safe and rapid method to identify a substantial number of patients at very low risk for acute myocardial injury and infarction.
Entities:
Keywords:
myocardial infarction; myocardial ischemia; troponin T
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