本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2312572

摘要内容如下：

背景

在ST段抬高型心肌梗死（STEMI）合并心源性休克的患者中，使用微型轴流泵进行临时机械循环支持对死亡率的影响尚不清楚。

方法

在一项国际、多中心、随机试验中，我们将STEMI和心源性休克患者分为两组，一组接受微型轴流泵（Impella CP）加标准护理，另一组仅接受标准护理。主要终点是180天时任何原因导致的死亡。复合安全性终点为严重出血、肢体缺血、溶血、装置故障或主动脉瓣反流恶化。

结果

共有360名患者接受了随机分组，其中355名患者被纳入最终分析（179名患者进入微轴流泵组，176名患者进入标准护理组）。患者的中位年龄为67岁，79.2%为男性。微轴流泵组179例患者中有82例（45.8%）因任何原因死亡，标准护理组176例患者中有103例（58.5%）因任何原因死亡（风险比为0.74；95%置信区间[CI]，0.55至0.99；P=0.04）。微型轴流泵组中有43名患者（24.0%）发生了复合安全性终点事件，标准治疗组中有11名患者（6.2%）发生了复合安全性终点事件（相对风险，4.74；95%置信区间，2.36至9.55）。微轴流泵组中有75名患者（41.9%）接受了肾替代治疗，标准治疗组中有47名患者（26.7%）接受了肾替代治疗（相对危险度为1.98；95%可信区间为1.27~3.09）。

结论

在STEMI相关心源性休克患者的治疗中，常规使用微轴流泵和标准护理，与单独使用标准护理相比，在180天内任何原因导致的死亡风险均较低。使用微型轴流泵时，复合不良事件的发生率较高。（由丹麦心脏基金会（Danish Heart Foundation）和ABIOMED资助；Danger Shock ClinicalTrials.gov，NCT01633502）。

英文原文如下：

Abstracts

BACKGROUND  The effects of temporary mechanical circulatory support with a microaxial flow pump on mortality among patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock remains unclear.

METHODS  In an international, multicenter, randomized trial, we assigned patients with STEMI and cardiogenic shock to receive a microaxial flow pump (Impella CP) plus standard care or standard care alone. The primary end point was death from any cause at 180 days. A composite safety end point was severe bleeding, limb ischemia, hemolysis, device failure, or worsening aortic regurgitation.

RESULTS  A total of 360 patients underwent randomization, of whom 355 were included in the final analysis (179 in the microaxial-flow-pump group and 176 in the standard-care group). The median age of the patients was 67 years, and 79.2% were men. Death from any cause occurred in 82 of 179 patients (45.8%) in the microaxial-flow-pump group and in 103 of 176 patients (58.5%) in the standard-care group (hazard ratio, 0.74; 95% confidence interval [CI], 0.55 to 0.99; P = 0.04). A composite safety end-point event occurred in 43 patients (24.0%) in the microaxial-flow-pump group and in 11 (6.2%) in the standard-care group (relative risk, 4.74; 95% CI, 2.36 to 9.55). Renal-replacement therapy was administered to 75 patients (41.9%) in the microaxial-flow-pump group and to 47 patients (26.7%) in the standard-care group (relative risk, 1.98; 95% CI, 1.27 to 3.09).

CONCLUSIONS  The routine use of a microaxial flow pump with standard care in the treatment of patients with STEMI-related cardiogenic shock led to a lower risk of death from any cause at 180 days than standard care alone. The incidence of a composite of adverse events was higher with the use of the microaxial flow pump. (Funded by the Danish Heart Foundation and Abiomed; DanGer Shock ClinicalTrials.gov number, NCT01633502.).

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