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DanGer休克试验与随机心源性休克试验及真实世界注册研究的对比分析。

Comparative analysis of the DanGer shock trial to randomized cardiogenic shock trials and real-world registries.

作者信息

Zordok Magdi, Buda Kevin G, Etiwy Muhammad, Dani Sourbha S, Ganatra Sarju, Basir Babar, Alaswad Khaldoon, Brilakis Emmanouil S, Megaly Michael

机构信息

Department of Medicine, Catholic Medical Center, Manchester, NH, United States of America.

Minneapolis Heart Institute, Abbott Northwestern Hospital, United States of America; Cardiology Division, Department of Internal Medicine, Hennepin Healthcare, United States of America.

出版信息

Cardiovasc Revasc Med. 2025 Jan 24. doi: 10.1016/j.carrev.2025.01.010.

Abstract

BACKGROUND

The Danish-German Cardiogenic (DanGer) Shock Trial reported lower mortality with a percutaneous micro-axial flow pump compared to standard care in patients with STEMI-related cardiogenic shock. It remains unclear how the DanGer Shock trial population compares to randomized controlled trials (RCTs) and real-world registries studying temporary mechanical circulatory support (tMCS) for acute myocardial infarction with cardiogenic shock (AMICS).

METHODS

A systematic review and meta-analysis of RCTs and registries involving tMCS for AMICS was performed. Patient characteristics and outcomes were compared to those in the DanGer Shock Trial.

RESULTS

From 2005 to 2023, seven RCTs (1201 patients) and ten registries (2100 patients) were analyzed. DanGer Shock patients had fewer comorbidities, lower blood pressure, lower Left ventricular ejection fraction (LVEF), higher heart rates, and shorter times to tMCS initiation (5.5 ± 2.7 vs. 19.1 ± 38.3 h, p < 0.0001) than RCT patients. They required shorter tMCS durations, less mechanical ventilation, and inotropic support. DanGer patients experienced fewer bleeding events, infections, and limb ischemia, with similar 30-day mortality but higher stroke rates. Compared to registry patients, DanGer Shock patients had fewer comorbidities but required longer tMCS, more mechanical ventilation, and inotropic support, with fewer complications and lower 30-day mortality.

CONCLUSION

DanGer Shock patients had better survival despite worse initial hemodynamics, possibly due to fewer comorbidities, earlier tMCS initiation, and an algorithmic treatment approach.

摘要

背景

丹麦-德国心源性(DanGer)休克试验报告称,与标准治疗相比,经皮微轴流泵可降低ST段抬高型心肌梗死(STEMI)相关心源性休克患者的死亡率。目前尚不清楚DanGer休克试验人群与研究急性心肌梗死合并心源性休克(AMICS)的临时机械循环支持(tMCS)的随机对照试验(RCT)和真实世界注册研究相比情况如何。

方法

对涉及AMICS的tMCS的RCT和注册研究进行了系统评价和荟萃分析。将患者特征和结局与DanGer休克试验中的情况进行比较。

结果

2005年至2023年,分析了7项RCT(1201例患者)和10项注册研究(2100例患者)。与RCT患者相比,DanGer休克患者的合并症较少、血压较低、左心室射血分数(LVEF)较低、心率较高,且开始tMCS的时间较短(5.5±2.7小时对19.1±38.3小时,p<0.0001)。他们需要的tMCS持续时间更短、机械通气更少以及使用血管活性药物支持更少。DanGer休克患者发生出血事件、感染和肢体缺血的情况较少,30天死亡率相似,但卒中发生率较高。与注册研究中的患者相比,DanGer休克患者的合并症较少,但需要更长时间的tMCS、更多的机械通气和血管活性药物支持,并发症较少且30天死亡率较低。

结论

尽管初始血流动力学较差,但DanGer休克患者的生存率更高,这可能是由于合并症较少、更早开始tMCS以及采用了算法化治疗方法。

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