Montgomery Connor M, Ashburn Nicklaus P, Snavely Anna C, Allen Brandon, Christenson Robert, Madsen Troy, McCord James, Mumma Bryn, Hashemian Tara, Supples Michael, Stopyra Jason, Wilkerson R Gentry, Mahler Simon A
Department of Emergency Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Department of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Acad Emerg Med. 2025 Jan;32(1):45-53. doi: 10.1111/acem.15014. Epub 2024 Sep 2.
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.
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.
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%).
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.
比较用于诊断急性冠状动脉综合征（ACS）的性别特异性与总体（非性别特异性）高敏心肌肌钙蛋白（hs-cTn）切点性能的数据有限。本研究旨在比较性别特异性与总体第99百分位数高敏心肌肌钙蛋白T（hs-cTnT）切点的安全性和有效性。
我们对STOP-CP队列进行了二次分析，该队列前瞻性纳入了美国8个地点（2017年1月25日至2018年9月6日）年龄≥21岁、初始心电图无ST段抬高且有ACS症状的急诊科患者。0小时和1小时hs-cTnT测量值均小于或等于第99百分位数（男性性别特异性为22 ng/L，女性为14 ng/L；总体为19 ng/L）的参与者被分类为排除组。安全性结局判定为30天时的心源性死亡或心肌梗死（MI）。有效性定义为分类到排除组的比例。使用McNemar检验和广义评分统计量比较两种策略之间的排除率和30天时的心源性死亡或MI发生率。使用净重新分类改善（NRI）指数进一步比较性能。
该分析纳入了1430例患者，其中45.8%（655/1430）为女性；平均年龄±标准差为57.6±12.8岁。30天时，12.8%（183/1430）发生心源性死亡或MI。与总体切点相比，使用性别特异性切点的排除率较低（70.6%[1010/1430]对72.5%[1037/1430]；p = 0.003）。在排除患者中，性别特异性（2.4%[24/1010]）与总体（2.3%[24/1037]）策略的30天时心源性死亡或MI发生率相似（p = 0.79）。在心源性死亡或MI患者中，性别特异性与总体切点正确重新分类了3名女性，错误重新分类了3名男性。性别特异性策略导致净27例患者被错误重新分类到纳入组。这导致NRI为-2.2%（95%CI-5.1%至0.8%）。
与总体切点策略相比，性别特异性hs-cTnT切点导致被排除的患者更少，但安全性没有改善。
