Background

Whether age impacts the recently demonstrated survival benefit of microaxial flow pump (mAFP) treatment in patients with ST-segment elevation myocardial infarction (STEMI) and cardiogenic shock (CS) is unknown.

Objectives

The purpose of this study was to assess the impact of age on mortality and complication rates in patients with STEMI-related CS randomized to standard care or mAFP on top of standard care.

Methods

This is a secondary analysis of the Danish-German Cardiogenic Shock (DanGer Shock) trial, an international, multicenter, open-label trial, in which 355 adult patients with STEMI-related CS were randomized to receive a mAFP (Impella CP) plus standard care or standard care alone. The primary outcome of 180-day all-cause mortality is analysed according to age and intervention.

Results

From lowest to highest age quartile, the median ages (range) were: 54 (31-59), 65 (60-69), 73 (70-76), and 81 (77-92) years. There were no differences in blood pressure, lactate level, left ventricular ejection fraction or shock severity at randomization across age groups.Mortality increased from lowest to highest quartile (31%, 47%, 61%, and 73%, respectively; log-rank p<0.001), with an adjusted odds ratio (OR) for death at 180 days of 7.85 (95% CI, 3.37-19.2; p<0.001) in the highest quartile compared to the lowest. The predicted risk of mortality was higher in the standard-care group until approximately 77 years, after which the predicted risk became higher in the mAFP group (p-interaction=0.2). In patients younger than 77 years, a reduced 180-day mortality was observed in patients randomized to the mAFP (OR, 0.45; 95% CI, 0.28-0.73; p=0.001), opposed to patients aged 77 years or older (OR, 1.52; 95% CI, 0.57–4.08; p=0.40), p=0.028 for interaction. Complications were more frequent in the mAFP group, but there were no apparent differences in incidence of complications across all ages.

Conclusions

This exploratory secondary analysis of the DanGer Shock trial demonstrates that elderly patients with STEMI-related CS experience high mortality and may not attain the same benefit from routine treatment with a mAFP as younger patients. Incorporating age as a factor in patient selection may enhance the overall benefit of this therapy. (DanGer Shock, NCT01633502)

中文翻译：

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使用微轴流泵治疗心源性休克的老年患者：危险吗？

 背景

年龄是否会影响最近证明的微轴流泵 （mAFP） 治疗对 ST 段抬高型心肌梗死 （STEMI） 和心源性休克 （CS） 患者的生存获益尚不清楚。

 目标

本研究的目的是评估年龄对 STEMI 相关 CS 患者死亡率和并发症发生率的影响，这些患者被随机分配到标准护理或 mAFP 标准护理之上。

 方法

这是对丹麦-德国心源性休克 （DanGer Shock） 试验的二次分析，这是一项国际、多中心、开放标签试验，其中 355 名患有 STEMI 相关 CS 的成年患者被随机分配接受 mAFP （Impella CP） 加标准护理或单独标准护理。根据年龄和干预分析 180 天全因死亡率的主要结局。

 结果

年龄中位数（范围）从最低到最高四分位数为：54 （31-59）、65 （60-69）、73 （70-76） 和 81 （77-92） 岁。不同年龄组的随机分组时血压、乳酸水平、左心室射血分数或休克严重程度没有差异。死亡率从最低四分位数增加到最高四分位数（分别为 31%、47%、61% 和 73%;对数秩 p<0.001），与最低四分位数相比，最高四分位数的 180 天死亡校正比值比 （OR） 为 7.85（95% CI，3.37-19.2;p<0.001）。标准护理组的预测死亡风险较高，直到大约 77 岁，之后 mAFP 组的预测风险变得更高 （p-交互作用=0.2）。在 77 岁以下的患者中，随机分配接受 mAFP 的患者 （OR， 0.45;95% CI， 0.28-0.73;p=0.001） 与 77 岁或以上的患者 （OR， 1.52;95% CI， 0.57-4.08;p=0.40） 相比，观察到 180 天死亡率降低，相互作用 p=0.028。mAFP 组并发症更常见，但所有年龄段的并发症发生率无明显差异。

 结论

DanGer Shock 试验的探索性二次分析表明，患有 STEMI 相关 CS 的老年患者的死亡率很高，并且可能无法从常规 mAFP 治疗中获得与年轻患者相同的益处。将年龄作为患者选择的一个因素可能会增强这种疗法的整体益处。（丹格冲击，NCT01633502）