Aims To assess differences in long-term outcome and functional status of patients with cardiogenic shock (CS) treated by percutaneous mechanical circulatory support (pMCS) and intra-aortic balloon pump (IABP). Methods and results Long-term follow-up of the multicentre, randomized IMPRESS in Severe Shock trial (NTR3450) was performed 5-year after initial randomization. Between 2012 and 2015, a total of 48 patients with severe CS from acute myocardial infarction (AMI) with ST-segment elevation undergoing immediate revascularization were randomized to pMCS by Impella CP (n = 24) or IABP (n = 24). For the 5-year assessment, all-cause mortality, functional status, and occurrence of major adverse cardiac and cerebrovascular event (MACCE) were assessed. MACCE consisted of death, myocardial re-infarction, repeat percutaneous coronary intervention, coronary artery bypass grafting, and stroke. Five-year mortality was 50% (n = 12/24) in pMCS patients and 63% (n = 15/24) in IABP patients (relative risk 0.87, 95% confidence interval 0.47–1.59, P = 0.65). MACCE occurred in 12/24 (50%) of the pMCS patients vs. 19/24 (79%) of the IABP patients (P = 0.07). All survivors except for one were in New York Heart Association Class I/II [pMCS n = 10 (91%) and IABP n = 7 (100%), P = 1.00] and none of the patients had residual angina. There were no differences in left ventricular ejection fraction between the groups (pMCS 52 ± 11% vs. IABP 48 ± 10%, P = 0.53). Conclusions In this explorative randomized trial of patients with severe CS after AMI, there was no difference in long-term 5-year mortality between pMCS and IABP-treated patients, supporting previously published short-term data and in accordance with other long-term CS trials.

中文翻译：

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严重休克试验中随机 IMPRESS 的长期 5 年结果：急性心肌梗死后心源性休克中的经皮机械循环支持与主动脉内球囊泵

目的 评估经皮机械循环支持 (pMCS) 和主动脉内球囊泵 (IABP) 治疗的心源性休克 (CS) 患者的长期预后和功能状态的差异。方法和结果 在初始随机分组后 5 年对多中心、随机 IMPRESS in Severe Shock 试验 (NTR3450) 进行了长期随访。在 2012 年至 2015 年期间，共有 48 名急性心肌梗死 (AMI) 严重 CS 患者接受了立即血运重建，他们被随机分配到 Impella CP (n = 24) 或 IABP (n = 24) 的 pMCS。对于 5 年评估，评估全因死亡率、功能状态和主要不良心脑血管事件 (MACCE) 的发生率。MACCE 包括死亡、心肌再梗死、重复经皮冠状动脉介入治疗、冠状动脉旁路移植术和中风。pMCS 患者的五年死亡率为 50%（n = 12/24），IABP 患者的 5 年死亡率为 63%（n = 15/24）（相对风险 0.87，95% 置信区间 0.47-1.59，P = 0.65）。MACCE 发生在 12/24 (50%) 的 pMCS 患者和 19/24 (79%) 的 IABP 患者 (P = 0.07)。除一名幸存者外，所有幸存者均处于纽约心脏协会 I/II 级 [pMCS n = 10 (91%) 和 IABP n = 7 (100%)，P = 1.00]，并且没有患者有残余心绞痛。两组之间的左心室射血分数没有差异（pMCS 52 ± 11% vs. IABP 48 ± 10%，P = 0.53）。结论 在这项针对 AMI 后严重 CS 患者的探索性随机试验中，pMCS 和 IABP 治疗的患者之间的长期 5 年死亡率没有差异，