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.
Original language | English (US) |
---|---|
Pages (from-to) | 271-282 |
Number of pages | 12 |
Journal | Journal of the American College of Cardiology |
Volume | 74 |
Issue number | 3 |
DOIs | |
State | Published - Jul 23 2019 |
Bibliographical note
Publisher Copyright:© 2019 American College of Cardiology Foundation
Keywords
- acute myocardial infarction
- high-sensitivity cardiac troponin
- risk stratification
- troponin
PubMed: MeSH publication types
- Journal Article
- Multicenter Study
- Observational Study
- Research Support, Non-U.S. Gov't