Sex and race differences in the performance of the European Society of Cardiology 0/1‐h algorithm with high‐sensitivity troponin T

• Published in: Clinical cardiology (Mahwah, N.J.) Vol. 47; no. 2; pp. e24199 - n/a
• Main Authors: Supples, Michael W., Snavely, Anna C., O'Neill, James C., Ashburn, Nicklaus P., Allen, Brandon R., Christenson, Robert H., Nowak, Richard, Wilkerson, R. Gentry, Mumma, Bryn E., Madsen, Troy, Stopyra, Jason P., Mahler, Simon A.
• Format: Journal Article
• Language: English
• Published: United States John Wiley & Sons, Inc 01.02.2024; John Wiley and Sons Inc
• Subjects: Acute coronary syndromes; Algorithms; Cardiology; Cardiovascular disease; Clinical Trial; Diabetes; Electrocardiography; Emergency medical care; Enrollments; Ethnicity; Heart attacks; Hyperlipidemia; Hypertension; Ischemia; Kidney diseases; Medical records; Patients; Performance evaluation; Regression analysis; Womens health; United States > US; Maryland; Australasia; Europe; Baltimore Maryland
• ISSN: 0160-9289; 1932-8737; 1932-8737
• DOI: 10.1002/clc.24199

The diagnostic performance of the high‐sensitivity troponin T (hs‐cTnT) European Society of Cardiology (ESC) 0/1‐h algorithm in sex and race subgroups of US Emergency Department (ED) patients is unclear. A pre‐planned subgroup analysis of the STOP‐CP cohort study was conducted. Participants with 0‐ and 1‐h hs‐cTnT measures from eight US EDs (1/2017 to 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. The proportion with the primary outcome in each zone was compared between subgroups with Fisher's exact tests. The negative predictive value (NPV) of the ESC 0/1 rule‐out zone for 30‐day CDMI was calculated and compared between subgroups using Fisher's exact tests. 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 myocardial infarction (MI) occurred in 12.9% (183/1422) of participants. Among patients stratified to the rule‐out zone, 30‐day cardiac death or MI occurred in 1.1% (5/436) of women versus 2.1% (8/436) of men (p = .40) and 1.2% (4/331) of non‐white patients versus 1.8% (9/490) of white patients (p = .58). The NPV for 30‐day cardiac death or MI was similar among women versus men (98.9% [95% confidence interval, CI: 97.3–99.6] vs. 97.9% [95% CI: 95.9–99.1]; p = .40) and among white versus non‐white patients (98.8% [95% CI: 96.9–99.7] vs. 98.2% [95% CI: 96.5–99.2]; p = .39). NPVs <99% in each subgroup suggest the hs‐cTnT ESC 0/1‐h algorithm may not be safe for use in US EDs. Trial Registration: High‐Sensitivity Cardiac Troponin T to Optimize Chest Pain Risk Stratification (STOP‐CP; ClinicalTrials.gov: NCT02984436; https://clinicaltrials.gov/ct2/show/NCT02984436). Primary outcome: Negative predictive value (NPV) for 30‐day cardiac death or myocardial infarction among sex and race subgroups of the STOP‐CP Study. Women NPV: 97.9% (95% confidence interval [CI]: 95.9–99.1). Men NPV: 98.9% (95% CI: 97.3‐99.6). Non‐white patients NPV: 98.2% (95% CI: 96.5–99.2). White patients NPV: 98.8% (95% CI: 96.9–99.7). Conclusion: The ESC 0/1‐h hs‐cTnT rule failed to achieve the commonly accepted NPV safety threshold of 99% for all subgroups.