Background: Major disparities between women and men in the diagnosis, management, and outcomes of acute coronary syndrome are well recognized. Objectives: The aim of this study was to evaluate the impact of implementing a high-sensitivity cardiac troponin I assay with sex-specific diagnostic thresholds for myocardial infarction in women and men with suspected acute coronary syndrome. Methods: Consecutive patients with suspected acute coronary syndrome were enrolled in a stepped-wedge, cluster-randomized controlled trial across 10 hospitals. Myocardial injury was defined as high-sensitivity cardiac troponin I concentration >99th centile of 16 ng/l in women and 34 ng/l in men. The primary outcome was recurrent myocardial infarction or cardiovascular death at 1 year. Results: A total of 48,282 patients (47% women) were included. Use of the high-sensitivity cardiac troponin I assay with sex-specific thresholds increased myocardial injury in women by 42% and in men by 6%. Following implementation, women with myocardial injury remained less likely than men to undergo coronary revascularization (15% vs. 34%) and to receive dual antiplatelet (26% vs. 43%), statin (16% vs. 26%), or other preventive therapies (p < 0.001 for all). The primary outcome occurred in 18% (369 of 2,072) and 17% (488 of 2,919) of women with myocardial injury before and after implementation, respectively (adjusted hazard ratio: 1.11; 95% confidence interval: 0.92 to 1.33), compared with 18% (370 of 2,044) and 15% (513 of 3,325) of men (adjusted hazard ratio: 0.85; 95% confidence interval: 0.71 to 1.01). Conclusions: Use of sex-specific thresholds identified 5 times more additional women than men with myocardial injury. Despite this increase, women received approximately one-half the number of treatments for coronary artery disease as men, and outcomes were not improved. (High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome [High-STEACS]; NCT01852123).
Bibliographical noteFunding Information:
This trial was funded by a Special Project Grant from the British Heart Foundation (BHF) (SP/12/10/29922) with additional support from a BHF-Turing Cardiovascular Data Science Award (BCDSA/100003) and a BHF Research Excellence Award (RE/18/5/34216). Drs. Lee, Shah, and Mills are supported by a Clinical Research Training Fellowship (FS/18/25/33454), an Intermediate Clinical Research Fellowship (FS/19/17/34172), and the Butler Senior Clinical Research Fellowship (FS/16/14/32023) from the BHF. Dr. Weir was supported by National Health Service Lothian through the Edinburgh Clinical Trials Unit. Abbott Laboratories provided cardiac troponin assay reagents, calibrators, and controls without charge. Drs. Shah, Chapman, and Lee have received honoraria from Abbott Diagnostics. Dr. Berry has received a research grant awarded to the University of Glasgow from AstraZeneca outside the submitted work. Dr. Apple has received research grants awarded to the Minneapolis Medical Research Foundation from Abbott Diagnostics, Siemens Diagnostics, Ortho-Clinical Diagnostics, and Beckman Coulter outside the submitted work; and has received personal fees from HyTest. Dr. Mills has received research grants awarded to the University of Edinburgh from Abbott Diagnostics and Siemens Diagnostics outside the submitted work; and has received honoraria from Abbott Diagnostics, Siemens Diagnostics, Roche Diagnostics, and Singulex. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- acute coronary syndrome
- high-sensitivity cardiac troponin
- myocardial infarction
- sex-specific threshold
PubMed: MeSH publication types
- Journal Article
- Multicenter Study
- Randomized Controlled Trial
- Research Support, Non-U.S. Gov't