BACKGROUND In the Danish-German Cardiogenic Shock (DanGer Shock) trial, use of a microaxial flow pump (mAFP) in patients with ST-segment elevation myocardial infarction (STEMI)-related CS led to lower all-cause mortality but higher rates of renal replacement therapy (RRT). In this prespecified analysis, rates and predictors of acute kidney injury (AKI) and RRT were assessed. METHODS In this international, randomized, open label, multicenter trial, 355 adult patients with STEMI-CS were randomized to mAFP (N=179) or standard care alone (N=176). AKI was defined according to Risk, Injury, and Failure, sustained Loss and End-stage kidney disease (RIFLE) criteria and assessed using logistic regression models. Use of RRT was assessed accounting for the competing risk of death using Fine-Gray subdistribution hazard models. RESULTS AKI (RIFLE≥1) was recorded in 110 patients (61%) in mAFP group and 79 (45%) in control group (p<0.01); RRT was used in 75 (42%) and 47 (27%) patients, respectively (p<0.01). About 2/3 of the RRTs were initiated within the first 24h from admission (n=48 (64%) in mAFP group, n=31 (66%) in control group). Occurrence of AKI and RRT were associated with higher 180-day mortality in both study arms. At 180 days, all patients alive were free of RRT. mAFP use was associated with higher rates of RRT, even when accounting for competing risk of death (subdistribution hazard: 1.67 [1.18-2.35]). This association was largely consistent among prespecified subgroups. Allocation to mAFP was associated with lower 180-day mortality irrespective of AKI or RRT (p=0.8 for interaction). Relevant predictors of AKI in both groups comprised reduced left ventricular ejection fraction, baseline kidney function, shock severity, bleeding events, and positive fluid balance. In addition, predictors of AKI specific to mAFP were suction events, higher pump speed, and longer duration of support. CONCLUSIONS Shock severity, allocation to mAFP, and device-related complications were associated with an increased risk of AKI. AKI was generally associated with higher mortality, but the allocation to mAFP consistently led to lower mortality rates at 180 days irrespective of the occurrence of AKI with or without RRT initiation.

中文翻译：

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微轴流泵的使用和梗死相关心源性休克的肾脏结局 - DanGer 休克试验的二次分析。


背景 在丹麦-德国心源性休克 （DanGer Shock） 试验中，在 ST 段抬高型心肌梗死 （STEMI） 相关 CS 患者中使用微轴流泵 （mAFP） 导致全因死亡率降低，但肾脏替代疗法 （RRT） 的发生率较高。在这项预先指定的分析中，评估了急性肾损伤 （AKI） 和 RRT 的发生率和预测因子。方法 在这项国际、随机、开放标签、多中心试验中，355 例成年 STEMI-CS 患者被随机分配到 mAFP 组 （N=179） 或单独标准治疗组 （N=176）。AKI 根据风险、损伤和失败、持续损失和终末期肾病 （RIFLE） 标准定义，并使用 logistic 回归模型进行评估。使用 Fine-Gray 子分布风险模型评估 RRT 的使用，并考虑竞争性死亡风险。结果 mAFP 组 110 例 （61%） 患者和 79 例 （45%） 患者记录到 AKI （RIFLE≥1） （p<0.01）;RRT 分别用于 75 例 （42%） 和 47 例 （27%） 患者 （p<0.01）。大约 2/3 的 RRT 是在入院后的前 24 小时内开始的 （mAFP 组 n=48 （64%），对照组 n=31 （66%））。在两个研究组中，AKI 和 RRT 的发生与较高的 180 天死亡率相关。在 180 天时，所有存活的患者均未发生 RRT。mAFP 的使用与较高的 RRT 发生率相关，即使考虑到竞争性的死亡风险 （亚分布风险： 1.67 [1.18-2.35]）。这种关联在预先指定的亚组中基本一致。与 AKI 或 RRT 无关，分配给 mAFP 与较低的 180 天死亡率相关 （相互作用 p=0.8）。两组 AKI 的相关预测因素包括左心室射血分数降低、基线肾功能、休克严重程度、出血事件和阳性体液平衡。 此外，mAFP 特异性 AKI 的预测因子是吸入事件、更高的泵速和更长的支持持续时间。结论 休克严重程度、 mAFP 分配和设备相关并发症与 AKI 风险增加相关。AKI 通常与较高的死亡率相关，但分配给 mAFP 始终导致 180 天时的死亡率降低，无论 AKI 的发生是否发生，无论是否开始 RRT。