July 1, 2019Journal of the American College of Cardiology
Myocardial Infarction Risk Stratification With a Single Measurement of High-Sensitivity Troponin I
Why the study?
Limited data exist on rapid risk-stratification strategies using U.S. Food and Drug Administration-cleared high-sensitivity cardiac troponin I assays.
Does a single measurement of hs-cTnI accurately identify patients at low and high risk for acute myocardial infarction among patients with suspected acute MI?
Structured PICO
Does a single measurement of hs-cTnI accurately identify patients at low and high risk for acute myocardial infarction among patients with suspected acute MI?
P
Population
2,212 patients with suspected acute myocardial infarction enrolled across 29 U.S. sites
I
Intervention
Single measurement of high-sensitivity cardiac troponin I (hs-cTnI) using Atellica IM TnIH and ADVIA Centaur TNIH assays
O
Outcome
Acute MI and composite of MI or death at 30 dayshard clinical
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“If you can send home 30%, 40%, 50% of patients that could then be re-seen as outpatients, the amount of savings in our healthcare system will be tremendous.”
“Not all hs-cTnI and hs-cTnT assays are the same, and each hs-assay used in practice needs to be validated both analytically and clinically as US patient presentations often differ than the rest of the world and often utilized differently by US providers.”
Implication
A single baseline hs-cTnI measurement <5 ng/L safely identifies nearly half of patients with suspected MI as low risk for 30-day adverse events, while levels ≥120 ng/L identify high-risk patients.
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.
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Cite This Study
Sandoval et al. (2019) studied this question.