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.
Bibliographical noteFunding Information:
The study was funded and designed by Siemens Healthineers for their 510-k Food and Drug Administration submission. The authors had total control of the data for independent analyses, interpretation, and writing. Dr. Sandoval has served on Advisory Boards for Roche Diagnostics and Abbott Diagnostics. Dr. Nowak has been a consultant for Siemens Healthineers, Roche Diagnostics, Beckman Coulter, Ortho Diagnostics, and Abbott. Dr. deFilippi has been a consultant for Abbott Diagnostics, FujiRebio, Metabolomics, Ortho Diagnostics, Roche Diagnostics, and Siemens Healthineers; and has received institutional research support from Inova; has received honoraria from WebMD; and receives royalties from UpToDate. Dr. Christenson has received consultant fees from Siemens Healthineers, Roche Diagnostics, Quidel Diagnostics, Becton Dickinson, and Beckman Coulter. Dr. Peacock has received research grants from Abbott, Braincheck, Immunarray, Janssen, Ortho Clinical Diagnostics, Relypsa, and Roche; has served as a consultant to Abbott, AstraZeneca, Bayer, Beckman, Boehringer Ingelheim, Ischemia Care, Dx, Immunarray, Instrument Labs, Janssen, Nabriva, Ortho Clinical Diagnostics, Relypsa, Roche, Quidel, and Siemens Healthineers; has provided expert testimony for Johnson and Johnson; and has stock/ownership interests in AseptiScope, Brainbox, Comprehensive Research Association, Emergencies in Medicine, and Ischemia DC. Dr. McCord has been a consultant for Siemens and Roche; and has received research support from Siemens, Abbott, Beckman, and Roche. Dr. Limkakeng has received grant funding from Roche Diagnostics, Abbott Laboratories, Bristol-Myers Squibb, Ischemia Care, GE, AstraZeneca, and Siemens Healthineers; and has served as a consultant to Biomeriux and ZS Pharma. Dr. Apple has served on the Board of Directors of HyTest Ltd.; has served on Advisory Boards for Siemens Diagnostics and Instrumentation Laboratory; has been a consultant for LumiraDx; has received institutional research funding from Abbott Diagnostics, Abbott Point of Care, Roche Diagnostics, Siemens Healthineers, Quidel/Alere, Ortho-Clinical Diagnostics, ET Healthcare, and Beckman Coulter; and serves as Associate Editor of Clinical Chemistry. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
© 2019 American College of Cardiology Foundation
Copyright 2019 Elsevier B.V., All rights reserved.
- acute myocardial infarction
- high-sensitivity cardiac troponin
- risk stratification
PubMed: MeSH publication types
- Journal Article
- Multicenter Study
- Observational Study
- Research Support, Non-U.S. Gov't