Stratified treatment of myocardial infarction with non-obstructive coronary arteries: the PROMISE trial.

Despite its clinical impact, no randomized clinical trials have hitherto evaluated optimal management strategy for MINOCA.

尽管其临床影响显著，但迄今为止尚无随机临床试验评估MINOCA的最佳管理策略。

The PROMISE trial was designed to assess whether a stratified treatment improves clinical outcomes in patients with MINOCA as compared to standard care.

PROMISE试验旨在评估分层治疗是否能改善MINOCA患者的临床结果，与标准护理相比。

Methods

PROMISE is a multicentre randomized trial. Patients with MINOCA were randomized 1:1 to either a stratified treatment based on a comprehensive diagnostic workup aimed at identifying the underlying aetiology, or to standard care.

PROMISE是一项多中心随机试验。MINOCA患者按1:1的比例随机分配，接受基于全面诊断工作以识别潜在病因的分层治疗，或接受标准护理。

The primary endpoint was the between-group difference in the change in angina status at 12 months, assessed by the Seattle Angina Questionnaire summary score (SAQSS).

主要终点是12个月时通过西雅图心绞痛问卷总结评分（SAQSS）评估的心绞痛状态组间差异。

The secondary endpoint was the incidenceof major adverse cardiovascular events (MACE), defined as the composite of all-cause mortality, myocardial infarction, stroke, heart failure hospitalization and repeated coronary angiography.

次要终点是重大不良心血管事件（MACE）的发生率，定义为全因死亡、心肌梗死、中风、心力衰竭住院和重复冠状动脉造影的复合终点。

The trial was terminated early upon recommendation by the Data and Safety Monitoring Board due to clear benefits observed in the intervention group and potential harm in the control group.

由于在干预组中观察到明确的益处以及对照组可能的伤害，数据和安全监测委员会建议提前终止试验。

Results

Of 101 randomized patients, 92 were confirmed as MINOCA and included in the final analysis (mean age 62 ± 13 years, 48% women; stratified treatment n = 45; standard care n = 47).

在101名随机分配的患者中，有92名被确认为MINOCA并纳入最终分析（平均年龄62±13岁，女性占48%；分层治疗组n=45；标准护理组n=47）。

At 12-month follow-up, SAQSS was significantly higher in the stratified treatment than in standard care group, with a mean between-group difference of +9.38 in favour of the stratified treatment (95% confidence interval6.81 to 11.95; P < .001).

在12个月的随访中，分层治疗组的SAQSS显著高于标准护理组，两组间平均差异为+9.38，有利于分层治疗（95%置信区间6.81至11.95；P < .001）。

MACE occurred in 1 patient (2.2%) in the stratified treatment and in 4 patients (8.5%) in the standard care group, though the difference was not statistically significant (P = .18).

主要不良心血管事件（MACE）在分层治疗组中发生于1名患者（2.2%），而在标准护理组中发生于4名患者（8.5%），尽管这一差异没有统计学意义（P = .18）。

Conclusions

In this first randomized trial of treatment strategies in MINOCA, a stratified treatment, based on comprehensive diagnostic assessment and aetiology-guided therapy, led to a significant improvement in angina-related health status.

在这项针对MINOCA治疗策略的首次随机试验中，基于全面诊断评估和病因指导治疗的分层治疗，显著改善了与心绞痛相关的生活质量。

While the study findings provide the first evidence supporting individualized management in this heterogeneous and often under-recognized patient population, these results require confirmation in a larger prospective study with longer follow-up.

虽然研究结果首次为这种异质性且常常被忽视的患者群体提供了个体化管理的证据，但这些结果需要在更大规模的前瞻性研究中，以及更长时间的随访后得到确认。

Methods

The primary endpoint was the between-group difference in the change in angina status at 12 months, assessed by the Seattle Angina Questionnaire summary score (SAQSS).

主要终点是12个月时通过西雅图心绞痛问卷总结评分（SAQSS）评估的心绞痛状态组间差异。