Accelerated Diagnostic Pathways for Suspected Acute Coronary Syndrome in Practice: A Randomized Trial of 0/1-Hour vs 0/3-Hour Troponin Testing.

However, implementation of these ADPs, with universal use of hs-cTns, has not been directly compared in randomized trials OBJECTIVES: This study sought to compare the efficiency and safety of the European Society of Cardiology (ESC) 0/1-hour and a 0/3-hour ADP when implemented in real-world clinical practice.

然而，这些ADPs的实施，包括普遍使用hs-cTns，并没有在随机试验中直接比较。

Methods

This pragmatic, randomized, noninferiority implementation trial compared the safety and efficiency of clinician decision making using these 2 pathways.

本研究旨在比较在真实世界临床实践中实施的欧洲心脏病学会（ESC）0/1小时和0/3小时ADP的效率和安全性。

To prevent incorporation bias, an independent hs-cTnI was used for formal adjudication using the fourth universal definition of myocardial infarction (MI).

这是一项实用的、随机的、非劣效性实施试验，比较了使用这两种路径的临床决策的安全性和效率。

Efficiency was judged by the proportion of patients discharged within 4 hours.

为了防止纳入偏倚，使用了独立的hs-cTnI进行正式的裁决，使用了第四版心肌梗死（MI）的普遍定义。

The safety endpoint was major adverse cardiac events (MACE) within 30 days (adjudicated index or representation type 1 MI, cardiovascular death, and urgent coronary revascularization) for those who were considered not to have ACS and discharged.

效率是通过在4小时内出院的患者比例来判断的。

The noninferiority margin, for absolute difference in sensitivity, between the ESC 0/1-hour and the 0/3-hour ADP was set at 3%, assessed with a 1-sided 97.5% CI.

安全终点是在30天内发生的重大不良心脏事件（MACE）（裁决的指数或代表性类型1 MI、心血管死亡和紧急冠状动脉再血管化），对于那些被认为没有ACS并被释放的患者。

Results

From December 2021 to July 2024, of 13,983 screened 3,543 individual patients with suspected ACS were recruited and consented from 2 major emergency departments in North-West England, with 100% follow-up achieved for all representations to any national hospital. The median age was 60 years (IQR: 49.5-70.5 years), 53% were men, 6.7%, and 7.6% had adjudicated index type 1 MI and MACE within 30 days, respectively.

对于ESC 0/1小时和0/3小时ADP之间的敏感性绝对差异，非劣效性边界设定为3%，使用单侧97.5% CI进行评估。

The turnaround time from sample to result for central laboratory hs-cTnT was 81 minutes (IQR: 69-101 minutes).

中央实验室hs-cTnT样本到结果的周转时间为81分钟（四分位数间距：69-101分钟）。

The proportion of patients discharged within 4 hours was relatively low and did not differ substantially (21.8% vs 19.2%, P = 0.07).

在4小时内出院的患者比例相对较低，且差异不大（21.8%对比19.2%，P=0.07）。

In addition, the 0/1-hour pathway was noninferior for safety, in patients discharged, compared with the 0/3-hour pathway, absolute difference in sensitivity was +4.2% (1-sided 97.5% CI: -2.5) in favor of the 0/1-hour pathway.

此外，与0/3小时途径相比，0/1小时途径在安全性上是非劣效的，对于出院患者来说，敏感性的绝对差异为+4.2%（单侧97.5%置信区间：-2.5），倾向于0/1小时途径。

The calculated sensitivities were 93.7% (95% CI: 88.4%-97.1%) vs 89.5% (95% CI: 82.7%-94.3%), respectively.

计算出的敏感性分别为93.7%（95%置信区间：88.4%-97.1%）和89.5%（95%置信区间：82.7%-94.3%）。

Conclusions

Implementation of the ESC 0/1-hour pathway failed to discharge significantly more patients within 4 hours of presentation compared with the 0/3-hour ADP.

与0/3小时ADP相比，实施ESC 0/1小时途径未能显著增加在到达后4小时内出院的患者数量。

In addition, The ESC 0/1-hour was noninferior to the 0/3-hour hs-cTn pathway for safety of discharge, although safety for both pathways was less than that imputed by observational studies.

此外，ESC 0/1小时途径在出院安全性上与0/3小时hs-cTn途径相比是非劣效的，尽管两种途径的安全性都低于观察性研究推断的安全性。

This trial demonstrates that perceived benefits to emergency department efficiency of a reduced sampling interval are mitigated by central laboratory turnaround times as well as system constraints.

这项试验表明，减少采样间隔对急诊科效率的感知益处被中央实验室的周转时间以及系统限制所抵消。

(Pragmatic Randomised Trial of the ESC 0/​1 Versus 0/​3 Hour Troponin Pathway [MACROS2]; NCT05322395).

（实用随机试验：ESC 0/1小时对比0/3小时肌钙蛋白途径[MACROS2]；NCT05322395）。