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Abstract Background Data comparing the performance of sex‐specific to overall (non–sex‐specific) high‐sensitivity cardiac troponin (hs‐cTn) cut‐points for diagnosing acute coronary syndrome (ACS) are limited. This study aims to compare the safety and efficacy of sex‐specific versus overall 99th percentile high‐sensitivity cardiac troponin T (hs‐cTnT) cut‐points. Methods We conducted a secondary analysis of the STOP‐CP cohort, which prospectively enrolled emergency department patients ≥ 21 years old with symptoms suggestive of ACS without ST‐elevation on initial electrocardiogram across eight U.S. sites (January 25, 2017–September 6, 2018). Participants with both 0‐ and 1‐h hs‐cTnT measures less than or equal to the 99th percentile (sex‐specific 22 ng/L for males, 14 ng/L for females; overall 19 ng/L) were classified into the rule‐out group. The safety outcome was adjudicated cardiac death or myocardial infarction (MI) at 30 days. Efficacy was defined as the proportion classified to the rule‐out group. McNemar's test and a generalized score statistic were used to compare rule‐out and 30‐day cardiac death or MI rates between strategies. Net reclassification improvement (NRI) index was used to further compare performance. Results This analysis included 1430 patients, of whom 45.8% (655/1430) were female; the mean ± SD age was 57.6 ± 12.8 years. At 30 days, cardiac death or MI occurred in 12.8% (183/1430). The rule‐out rate was lower using sex‐specific versus overall cut‐points (70.6% 1010/1430 vs. 72.5% 1037/1430; p = 0.003). Among rule‐out patients, the 30‐day cardiac death or MI rates were similar for sex‐specific (2.4% 24/1010) vs. overall (2.3% 24/1037) strategies ( p = 0.79). Among patients with cardiac death or MI, sex‐specific versus overall cut‐points correctly reclassified three females and incorrectly reclassified three males. The sex‐specific strategy resulted in a net of 27 patients being incorrectly reclassified into the rule‐in group. This led to an NRI of −2.2% (95% CI −5.1% to 0.8%). Conclusions Sex‐specific hs‐cTnT cut‐points resulted in fewer patients being ruled out without an improvement in safety compared to the overall cut‐point strategy.
Montgomery et al. (Mon,) studied this question.