Objective To evaluate the impact of implementing a high sensitivity assay for cardiac troponin I on long term outcomes in patients with suspected acute coronary syndrome. Design Secondary observational analysis of a stepped wedge, cluster randomised controlled trial. Setting 10 secondary and tertiary care centres in Scotland, UK. Participants 48 282 consecutive patients with suspected acute coronary syndrome. Myocardial injury was defined as any high sensitivity assay result for cardiac troponin I >99th centile of 16 ng/L in women and 34 ng/L in men. Intervention Hospital sites were randomly allocated to either early (n=5 hospitals) or late (n=5 hospitals) implementation of a high sensitivity cardiac troponin I assay with sex specific diagnostic thresholds. Main outcome measure The main outcome was myocardial infarction or death at five years. Results 10 360 patients had cardiac troponin concentrations greater than the 99th centile, of whom 1771 (17.1%) were reclassified by the high sensitivity assay. The five year incidence of subsequent myocardial infarction or death before and after implementation of the high sensitivity assay was 29.4% (5588/18 978) v 25.9% (7591/29 304), respectively, in all patients (adjusted hazard ratio 0.97, 95% confidence interval 0.93 to 1.01), and 63.0% (456/720) v 53.9% (567/1051), respectively, in those reclassified by the high sensitivity assay (0.82, 0.72 to 0.94). After implementation of the high sensitivity assay, a reduction in subsequent myocardial infarction or death was observed in patients with non-ischaemic myocardial injury (0.83, 0.75 to 0.91) but not in those with type 1 or type 2 myocardial infarction (0.92, 0.83 to 1.01 and 0.98, 0.84 to 1.14). Conclusions Implementation of a high sensitivity cardiac troponin I assay in the assessment of patients with suspected acute coronary syndrome was associated with a reduced risk of subsequent myocardial infarction or death at five years in those reclassified by the high sensitivity assay. Improvements in outcome were greatest in patients with non-ischaemic myocardial injury, suggesting a broader benefit beyond the identification of myocardial infarction. Trial registration ClinicalTrials.gov [NCT01852123][1]. The High-STEACS trial makes use of several routine electronic healthcare data sources that are linked, deidentified, and held in a national safe haven, which is accessible by approved individuals who have undertaken the necessary governance training. Summary data can be made available upon request to the corresponding author. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01852123&atom=%2Fbmj%2F383%2Fbmj-2023-075009.atom

中文翻译：

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高灵敏度心肌肌钙蛋白 I 测定的实施与五年内心肌梗塞或死亡的风险：阶梯楔形、整群随机对照试验的观察分析

目的 评估对疑似急性冠状动脉综合征患者实施高灵敏度心肌肌钙蛋白 I 检测对长期结果的影响。设计阶梯楔形、整群随机对照试验的二次观察分析。在英国苏格兰设立10个二级和三级护理中心。研究对象为 48 282 名连续疑似急性冠状动脉综合征患者。心肌损伤定义为心肌肌钙蛋白 I >99th 百分位的任何高灵敏度检测结果，女性为 16 ng/L，男性为 34 ng/L。干预 医院地点被随机分配到早期（n=5 家医院）或晚期（n=5 家医院）实施具有性别特异性诊断阈值的高灵敏度心肌肌钙蛋白 I 测定。主要结局指标 主要结局是五年内心肌梗死或死亡。结果 10 360 例患者心肌肌钙蛋白浓度大于 99 百分位数，其中 1 771 例（17.1%）通过高灵敏度检测被重新分类。所有患者在实施高灵敏度测定前后的五年内心肌梗死或死亡发生率分别为 29.4% (5588/18 978) 和 25.9% (7591/29 304)（调整后的风险比为 0.97, 95通过高灵敏度测定重新分类的样本（0.82、0.72 至 0.94）分别为 % 置信区间（0.93 至 1.01）和 63.0%（456/720）v 53.9%（567/1051）。实施高灵敏度测定后，在非缺血性心肌损伤患者中观察到随后的心肌梗死或死亡减少（0.83，0.75至0.91），但在1型或2型心肌梗死患者中没有观察到（0.92，0.83至0.91）。 1.01 和 0.98、0.84 至 1.14）。结论 在评估疑似急性冠状动脉综合征患者时实施高灵敏度心肌肌钙蛋白 I 测定与通过高灵敏度测定重新分类的患者五年后发生心肌梗死或死亡的风险降低相关。非缺血性心肌损伤患者的预后改善最大，这表明除了识别心肌梗死之外还有更广泛的益处。试验注册 ClinicalTrials.gov [NCT01852123][1]。High-STEACS 试验利用了多个常规电子医疗保健数据源，这些数据源相互关联、去识别化并保存在国家安全港中，接受过必要治理培训的批准个人可以访问这些数据源。可以根据相应作者的要求提供摘要数据。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01852123&atom=%2Fbmj%2F383%2Fbmj-2023-075009.atom