The real-world effectiveness and safety of a 0/1-hour accelerated protocol using high-sensitivity cardiac troponin (hs-cTn) to exclude myocardial infarction (MI) compared to routine care in the United States is uncertain. The objective was to compare a 0/1-hour accelerated protocol for evaluation of MI to a 0/3-hour standard care protocol. The RACE-IT trial was a stepped-wedge, randomized trial across 9 emergency departments (EDs) that enrolled 32,609 patients evaluated for possible MI from July 2020 through April 2021. Patients undergoing high-sensitivity cardiac troponin I testing with concentrations less than or equal to 99th percentile were included. Patients who had MI excluded by the 0/1-hour protocol could be discharged from the ED. Patients in the standard care protocol had 0- and 3-hour troponin testing and application of a modified HEART score to be eligible for discharge. The primary endpoint was the proportion of patients discharged from the ED without 30-day death or MI. There were 13,505 and 19,104 patients evaluated in the standard care and accelerated protocol groups, respectively, of whom 19,152 (58.7%) were discharged directly from the ED. There was no significant difference in safe discharges between standard care and the accelerated protocol (59.5% vs 57.8%; adjusted odds ratio (aOR)=1.05, 95% confidence interval [CI] 0.95 to 1.16). At 30 days, there were 90 deaths or MIs with 38 (0.4%) in the standard care group and 52 (0.4%) in the accelerated protocol group (aOR=0.84, 95% CI 0.43 to 1.68). A 0/1-hour accelerated protocol using high-sensitivity cardiac troponin I did not lead to more safe ED discharges compared with standard care.

中文翻译：

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使用高敏心肌肌钙蛋白 I 进行超过 1 小时的急性冠脉综合征快速评估：一项基于美国的阶梯式楔形随机试验


与美国的常规护理相比，使用高敏心肌肌钙蛋白 （hs-cTn） 排除心肌梗死 （MI） 的 0/1 小时加速方案的实际有效性和安全性尚不确定。目的是比较用于评估 MI 的 0/1 小时加速方案与 0/3 小时标准护理方案。RACE-IT 试验是一项跨越 9 个急诊科 （ED） 的阶梯式楔形随机试验，招募了 32,609 名在 2020 年 7 月至 2021 年 4 月期间接受可能心肌梗死评估的患者。纳入接受浓度小于或等于第 99 个百分位数的高敏心肌肌钙蛋白 I 检测的患者。被 0/1 小时方案排除 MI 的患者可以从急诊室出院。标准护理方案中的患者进行 0 小时和 3 小时的肌钙蛋白检测，并应用改良的 HEART 评分才有资格出院。主要终点是无 30 天死亡或 MI 的急诊科出院患者比例。标准护理组和加速方案组分别有 13,505 名和 19,104 名患者接受评估，其中 19,152 名 （58.7%） 直接从急诊科出院。标准护理和加速方案之间的安全出院率无显著差异（59.5% vs 57.8%;校正比值比 （aOR）=1.05,95% 置信区间 [CI] 0.95 至 1.16）。30 天时，有 90 例死亡或心肌梗死，其中标准治疗组 38 例 （0.4%），加速方案组 52 例 （0.4%） （aOR=0.84,95% CI 0.43 至 1.68）。与标准护理相比，使用高敏心肌肌钙蛋白 I 的 0/1 小时加速方案并未导致更安全的 ED 出院。