Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock
Jacob E. Møller, Thomas Engstrøm, Lisette O. Jensen, et al
N Engl J Med Published April 7, 2024
DOI: 10.1056/NEJMoa2312572
Abstract
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.
背景
在ST段抬高型心肌梗死（STEMI）并发心源性休克的患者中，使用微轴流泵进行临时机械循环支持对死亡率的影响仍不明确。
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.
方法
在一项国际多中心随机试验中，我们将STEMI伴心源性休克患者分配接受微轴流泵（Impella CP）加标准治疗或仅接受标准治疗。主要终点是180天内全因死亡。复合安全终点是严重出血、肢体缺血、溶血、设备故障或主动脉瓣反流恶化。
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).
结果
共有360名患者接受了随机分组，其中355人被纳入最终分析（微轴流泵179人，标准治疗组176人）。患者的中位年龄为67岁，79.2%为男性。微轴流泵179例患者中有82例（45.8%）因任何原因死亡，标准治疗组176例患者中有103例（58.5%）因任何原因死亡（危险比， 0.74；95% 置信区间 [CI]，0.55~0.99；P=0.04）。微轴流泵有43名患者（24.0%）发生了复合安全终点事件，标准治疗组为11名患者（6.2%）（相对风险，4.74；95% CI，2.36~9.55）。微轴流泵组和标准治疗组分别有75名患者（41.9%）和47 名患者（26.7%）接受了肾脏替代治疗（相对风险，1.98；95% CI，1.27~3.09）。
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.)
结论
在治疗STEMI相关心源性休克患者时，和标准治疗相比，常规使用微轴流泵联合标准治疗可降低180天的全因死亡风险。使用微轴流泵的复合不良事件发生率更高。(由丹麦心脏基金会和Abiomed资助；DanGer Shock在ClinicalTrials.gov注册号为NCT01633502）。
