Key result
The high-sensitivity troponin T ESC 0/1-hour algorithm achieved similar negative predictive values for 30-day cardiac death or MI in women (98.9%) and men (97.9%), failing to reach the ≥99% safety threshold in any subgroup.
Why the study?
The diagnostic performance of the high-sensitivity troponin T ESC 0/1-hour algorithm across sex and race subgroups was unclear, particularly in US ED patients.
Does the hs-cTnT ESC 0/1-hour algorithm safely rule out 30-day cardiac death or MI across sex and race subgroups in U.S. ED patients with suspected ACS?
Cohort (n=1,422)
Yes
Does the hs-cTnT ESC 0/1-hour algorithm safely rule out 30-day cardiac death or MI across sex and race subgroups in U.S. ED patients with suspected ACS?
Odds Ratio: 0.55 (95% CI 0.16–1.65)
Absolute Event Rate: 1.1% vs 2.1%
p-value: p=0.40
The ESC 0/1-hour hs-cTnT algorithm failed to achieve a ≥99% negative predictive value for 30-day cardiac death or MI in any sex or race subgroup among U.S. ED patients, suggesting it may not be safe for standalone use in this population.
Background The diagnostic performance of the high-sensitivity troponin T (hs-cTnT) European Society of Cardiology (ESC) 0/1-hour algorithm in sex and race subgroups is unclear, particularly in U.S. Emergency Department (ED) patients. Methods A pre-planned subgroup analysis of the STOP-CP cohort study was conducted. Participants with 0- and 1-hour hs-cTnT measures (Roche Diagnostics; Basel, Switzerland), prospectively enrolled at eight U.S. EDs from 1/2017-9/2018, were stratified into rule-out, observation, and rule-in zones using the hs-cTnT ESC 0/1 algorithm. The primary outcome was adjudicated 30-day cardiac death or MI. Rates of patient stratification to each ESC 0/1 zone and the proportion with 30-day cardiac death or MI in each zone were compared between subgroups with Fisher’s-exact tests. The negative predictive value (NPV) of the ESC 0/1 rule-out zone for 30-day cardiac death or MI was calculated and compared between subgroups using Fisher’s exact tests. Results Of the 1422 patients enrolled, 54.2% (770/1422) were male and 58.1% (826/1422) white with a mean age of 57.6 ± 12.8 years. At 30 days, cardiac death or MI occurred in 12.9% (183/1422) of participants. The ESC 0/1-h algorithm ruled-out more women than men [66.9% (436/652) vs 50.0% (385/770); p<0.001] and a similar proportion of white vs non-white patients [59.3% (490/826) vs 55.5% (331/596); p=0.16]. Among patients stratified to the rule-out zone, 30-day cardiac death or MI occurred in 1.1% (5/436) of women vs 2.1% (8/436) of men (p=0.40) and 1.2% (4/331) of non-white patients vs 1.8% (9/490) of white patients (p=0.58). The NPV for 30-day cardiac death or MI was similar among women vs men [98.9% (95%CI 97.3-99.6) vs 97.9% (95%CI 95.9-99.1); p = 0.40] and among white vs non-white patients [98.8% (95%CI 96.9-99.7) vs 98.2% (95%CI 96.5-99.2); p=0.39]. Conclusions The ESC 0/1-h hs-cTnT algorithm ruled-out more women than men, but achieved similar NPV for 30-day cardiac death or MI in all subgroups. NPVs <99% in each subgroup suggests the hs-cTnT ESC 0/1-h algorithm may not be safe for U.S. ED use. Trial Registration High-Sensitivity Cardiac Troponin T to Optimize Chest Pain Risk Stratification (STOP-CP; ClinicalTrials.gov: NCT02984436 ; https://clinicaltrials.gov/ct2/show/NCT02984436 ) What is Known The European Society of Cardiology high-sensitivity troponin T (hs-cTnT) 0/1-hour algorithm has been validated as a tool to rule-out myocardial infarction (MI). Evaluations of its performance differences based on sex and race are limited. What the Study Adds In this multisite U.S. cohort study of 1422 adults, the high-sensitivity troponin T (hs-cTnT) ESC 0/1-hour algorithm had a similar NPV in men vs women and white vs non-white patients but did not achieve ≥99% NPV for 30-day cardiac death or MI in any subgroup. Emergency providers should be aware of the potential limitations of using the ESC 0/1-hour hs-cTnT algorithm for risk stratification because it may not satisfactorily exclude 30-day cardiac death or MI in any subgroup of ED patients (men, women, white patients, or non-white patients) with acute chest pain.
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Supples et al. (2023) conducted a cohort in Acute chest pain / possible acute coronary syndrome (n=1,422). European Society of Cardiology (ESC) 0/1-hour algorithm with high-sensitivity troponin T vs. Men and white patients (subgroup comparisons) was evaluated on 30-day cardiac death or MI in the rule-out zone (women vs. men) (OR 0.55, 95% CI 0.16-1.65, p=0.40). The high-sensitivity troponin T ESC 0/1-hour algorithm achieved similar negative predictive values for 30-day cardiac death or MI in women (98.9%) and men (97.9%), failing to reach the ≥99% safety threshold in any subgroup.
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