Journal
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Volume 74, Issue 3, Pages 271-282Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacc.2019.05.058
Keywords
acute myocardial infarction; high-sensitivity cardiac troponin; risk stratification; troponin
Categories
Funding
- Siemens Healthineers
- Inova
- Abbott
- Braincheck
- Immunarray
- Janssen
- Ortho Clinical Diagnostics
- Relypsa
- Roche
- Siemens
- Beckman
- Roche Diagnostics
- Abbott Laboratories
- Bristol-Myers Squibb
- Ischemia Care
- GE
- AstraZeneca
- Abbott Diagnostics
- Abbott Point of Care
- Quidel/Alere
- Ortho-Clinical Diagnostics
- ET Healthcare
- Beckman Coulter
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BACKGROUND Limited data exist on rapid risk-stratification strategies using the U.S. Food and Drug Administration-cleared high-sensitivity cardiac troponin I (hs-cTnI) assays. OBJECTIVES This study sought to examine single measurement hs-cTnI to identify patients at low and high risk for acute myocardial infarction (MI). METHODS This was a prospective, multicenter, observational study of patients with suspected acute MI enrolled across 29 U.S. sites with hs-cTnI measured using the Atellica IM TnIH and ADVIA Centaur TNIH (Siemens Healthineers) assays. To identify low-risk patients, sensitivities and negative predictive values (NPVs) for acute MI and MI or death at 30 days were examined across baseline hs-cTnI concentrations. To identify high-risk patients, positive predictive values and specificities for acute MI were evaluated. RESULTS Among 2,212 patients, acute MI occurred in 12%. The limits of detection or quantitation resulted in excellent sensitivities (range 98.6% to 99.6%) and NPVs (range 99.5% to 99.8%) for acute MI or death at 30 days across both assays. An optimized threshold of < 5 ng/l identified almost one-half of all patients as low risk, with sensitivities of 98.6% (95% confidence interval: 97.2% to 100%) and NPVs of 99.6% (95% confidence interval: 99.2% to 99.9%) for acute MI or death at 30 days across both assays. For high-risk patients, hs-cTnI >= 120 ng/l resulted in positive predictive values for acute MI of >= 70%. CONCLUSIONS Recognizing the continuous relationship between baseline hs-cTnI and risk for adverse events, using 2 Food and Drug Administration-cleared hs-cTnI assays, an optimized threshold of < 5 ng/l safely identified almost one-half of all patients as low risk at presentation, with hs-cTnI >= 120 ng/l identifying high-risk patients. (C) 2019 by the American College of Cardiology Foundation.
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