Sex-Specific Microaxial Flow Pump Use and Outcomes in Infarct-Related Cardiogenic Shock in the DanGer Shock Trial.

The objective of this secondary analysis of the Danish-German Cardiogenic Shock Trial (DanGer Shock) was to determine sex differences in baseline characteristics, in-hospital course, and the effectiveness of mAFP in STEMI-CS.

这项对丹麦-德国心源性休克试验（DanGer Shock）的次要分析旨在确定STEMI-CS患者中性别差异在基线特征、住院过程以及mAFP的有效性。

Methods

This was a prespecified sex-specific secondary analysis of the international, multicenter, open-label, randomized DanGer Shock Trial. The primary outcome was 180-day all-cause mortality, analyzed by sex and randomized treatment assignment.

这是国际、多中心、开放标签、随机的DanGer Shock试验的预先指定的性别特定的次要分析。主要结果是180天的全因死亡率，按性别和随机治疗分配进行分析。

Results

From 2013 to 2023, 355 patients (74 [20.8%] women, 281 [79.2%] men) with STEMI-CS excluding comatose cardiac arrest were enrolled; 179 were randomized to mAFP (37 women) and 176 to standard care (37 women).

从2013年到2023年，共有355名患者（女性74名[20.8%]，男性281名[79.2%]）被纳入研究，这些患者均患有STEMI-CS，但排除了昏迷的心脏骤停患者；其中179名患者被随机分配到mAFP治疗组（女性37名），176名患者被随机分配到标准治疗组（女性37名）。

In an accompanying registry of excluded patients (n = 495), women represented 25.7% (P = 0.10).

在一份排除患者的相关登记中（n = 495），女性占比25.7%（P = 0.10）。

At baseline, women were significantly older, and time from symptom onset to randomization was 2.2-fold longer in women than in men.

在基线时，女性显著更年长，女性从症状出现到随机化的时间是男性的2.2倍。

Compared with men, women had significantly higher 180-day all-cause mortality (64.9% vs 48.8%; P = 0.015).

与男性相比，女性在180天内的全因死亡率显著更高（64.9%对48.8%；P=0.015）。

There was no significant interaction for sex and treatment assignment with respect to 180-day all-cause mortality (P value for interaction = 0.18), yet women (HR: 1.01 [95% CI: 0.58-1.79]) appeared to derive less benefit from mAFP treatment than male patients (HR: 0.66 [95% CI: 0.47-0.93]).

性别与治疗分配对于180天全因死亡率没有显著的交互作用（交互作用的P值=0.18），然而女性（HR: 1.01 [95% 置信区间: 0.58-1.79]）似乎从mAFP治疗中获得的益处比男性患者（HR: 0.66 [95% 置信区间: 0.47-0.93]）要少。

This difference was attenuated in patients aged ≤76 years: women (n = 41) HR: 0.66 (95% CI: 0.25-1.76) and men (n = 233) HR: 0.61 (95% CI: 0.40-0.92) (P value for interaction = 0.92).

在年龄≤76岁的患者中，这种差异有所减弱：女性（n = 41）的风险比（HR）为0.66（95%置信区间：0.25-1.76），男性（n = 233）的风险比（HR）为0.61（95%置信区间：0.40-0.92）（交互作用的P值为0.92）。

Data from up to 10 years of follow-up support the treatment effect in younger patients, regardless of sex: women HR: 0.45 (95% CI: 0.19-1.09); men HR: 0.57 (95% CI: 0.40-0.82).

长达10年的随访数据支持在年轻患者中，无论性别，治疗效果均得到支持：女性的风险比（HR）为0.45（95%置信区间：0.19-1.09）；男性的风险比（HR）为0.57（95%置信区间：0.40-0.82）。

Conclusions

In DanGer Shock, women with STEMI-CS were older and presented later after onset of symptoms, resulting in higher mortality rates.

在DanGer Shock研究中，患有STEMI-CS的女性年龄较大，并且在症状发作后更晚就医，导致了更高的死亡率。

This may have led to the apparent reduced treatment effect in women, but interaction between treatment allocation and sex was not significant, and data showing a benefit of mAFP appeared particularly in younger patients, regardless of sex.

这可能导致女性治疗效果看似降低，但治疗分配与性别的相互作用并不显著，且显示mAFP益处的数据特别出现在年轻患者中，无论性别如何。

As this is a secondary, nonpowered analysis that includes few women, its results must be considered hypothesis generating.

由于这是一项次要的、非功效分析，其中包含的女性人数较少，因此其结果必须被视为假设生成。

(Danish Cardiogenic Shock Trial [DanShock]; NCT01633502).

（丹麦心源性休克试验[DanShock]；NCT01633502）。