Diagnostic Performance of High-Sensitivity Cardiac Troponin T Strategies and Clinical Variables in a Multisite US
Brandon R Allen1, Robert H Christenson2, Scott A Cohen1
1Department of Emergency Medicine, College of Medicine (B.R.A., S.A.C., C.M.), University of Florida, Gainesville.
Insights
Combining a low-risk HEART score with initial high-sensitivity troponin T (hs-cTnT) below the limit of quantification demonstrates a 99% negative predictive value for 30-day major adverse cardiac events (MACEs). This strategy is effective for emergency department patients with possible acute coronary syndrome.
Area of Science:
- Cardiology
- Emergency Medicine
- Diagnostic Accuracy
Background:
- European data support using low high-sensitivity troponin (hs-cTn) or 0/1-hour algorithms to rule out myocardial infarction in emergency departments.
- Limited US data exist to validate these diagnostic strategies for acute coronary syndrome.
- This study aimed to evaluate hs-cTnT performance in a US cohort.
Purpose of the Study:
- To assess the diagnostic performance of initial hs-cTnT below the limit of quantification (LOQ).
- To evaluate a 0/1-hour hs-cTnT algorithm for excluding major adverse cardiac events (MACEs).
- To determine the combined utility of hs-cTnT strategies with the HEART score for MACE exclusion.
Main Methods:
- Prospective cohort study at 8 US sites involving adult emergency department patients with acute coronary syndrome symptoms.
- Measured baseline and 1-hour hs-cTnT levels; providers calculated HEART scores blinded to results.
- Adjudicated 30-day MACEs (cardiac death, MI, revascularization) and calculated negative predictive values (NPVs).
Main Results:
- Among 1462 participants, 32.8% had initial hs-cTnT below LOQ, yielding an 98.3% NPV for 30-day MACEs.
- A low-risk HEART score with initial hs-cTnT below LOQ achieved a 99.0% NPV for 30-day MACEs.
- The 0/1-hour algorithm ruled out 57.8% of patients with a 97.2% NPV; adding a low HEART score improved NPV to 98.4%.
Conclusions:
- An initial hs-cTnT below LOQ combined with a low-risk HEART score demonstrated a 99% NPV for 30-day MACEs in a US cohort.
- The 0/1-hour hs-cTnT algorithm alone or with the HEART score did not consistently achieve >99% NPV.
- Findings support the combined strategy for safely excluding MACEs in emergency department patients.
Background:
European data support the use of low high-sensitivity troponin (hs-cTn) measurements or a 0/1-hour (0/1-h) algorithm for myocardial infarction to exclude major adverse cardiac events (MACEs) among patients in the emergency department with possible acute coronary syndrome. However, modest US data exist to validate these strategies. This study evaluated the diagnostic performance of an initial hs-cTnT measure below the limit of quantification (LOQ: 6 ng/L), a 0/1-h algorithm, and their combination with history, ECG, age, risk factors, and initial troponin (HEART) scores for excluding MACE in a multisite US cohort.
Methods:
A prospective cohort study was conducted at 8 US sites, enrolling adult patients in the emergency department with symptoms suggestive of acute coronary syndrome and without ST-elevation on ECG. Baseline and 1-hour blood samples were collected, and hs-cTnT (Roche; Basel, Switzerland) was measured. Treating providers blinded to hs-cTnT results prospectively calculated HEART scores. MACE (cardiac death, myocardial infarction, and coronary revascularization) at 30 days was adjudicated. The proportion of patients with initial hs-cTnT measures below the LOQ and risk according to a 0/1-h algorithm was determined. The negative predictive value (NPV) was calculated for both strategies when used alone or with a HEART score.
Results:
Among 1462 participants with initial hs-cTnT measures, 46.4% (678 of 1462) were women and 37.1% (542 of 1462) were Black with an age of 57.6±12.9 (mean±SD) years. MACEs at 30 days occurred in 14.4% (210 of 1462) of participants. Initial hs-cTnT measures below the LOQ occurred in 32.8% (479 of 1462), yielding an NPV of 98.3% (95% CI, 96.7-99.3) for 30-day MACEs. A low-risk HEART score with an initial hs-cTnT below the LOQ occurred in 20.1% (294 of 1462), yielding an NPV of 99.0% (95% CI, 97.0-99.8) for 30-day MACEs. A 0/1-h algorithm was complete in 1430 patients, ruling out 57.8% (826 of 1430) with an NPV of 97.2% (95% CI, 95.9-98.2) for 30-day MACEs. Adding a low HEART score to the 0/1-h algorithm ruled out 30.8% (441 of 1430) with an NPV of 98.4% (95% CI, 96.8-99.4) for 30-day MACEs.
Conclusions:
In a prospective multisite US cohort, an initial hs-cTnT below the LOQ combined with a low-risk HEART score has a 99% NPV for 30-day MACEs. The 0/1-h hs-cTnT algorithm did not achieve an NPV >99% for 30-day MACEs when used alone or with a HEART score. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02984436.
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