Yader Sandoval1, Richard Nowak2, Christopher R deFilippi3, Robert H Christenson4, W Frank Peacock5, James McCord6, Alexander T Limkakeng7, Anne Sexter8, Fred S Apple9. 1. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota. Electronic address: https://twitter.com/yadersandoval. 2. Department of Emergency Medicine, Henry Ford Health System, Detroit, Michigan. 3. Inova Heart and Vascular Institute, Falls Church, Virginia. 4. Core Laboratories and Point of Care Services, University of Maryland School of Medicine, Baltimore, Maryland. 5. Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas. 6. Heart & Vascular Institute and Department of Internal Medicine, Henry Ford Hospital, Detroit, Michigan. 7. Division of Emergency Medicine, Duke University, School of Medicine, Durham, North Carolina. 8. Chronic Disease Research Group, Hennepin Healthcare Research Institute, Minneapolis, Minnesota. 9. Department of Laboratory Medicine and Pathology, Hennepin Healthcare/Hennepin County Medical Center, Minneapolis, Minnesota; Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota. Electronic address: apple004@umn.edu.
Abstract
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.
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.
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