心梗相关性心源性休克的临时机械循环支持:对随访 6 个月的随机试验进行的个体患者数据荟萃分析。

IF 98.4 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL
The Lancet Pub Date : 2024-09-14 Epub Date: 2024-09-02 DOI:10.1016/S0140-6736(24)01448-X
Holger Thiele, Jacob E Møller, Jose P S Henriques, Margriet Bogerd, Melchior Seyfarth, Daniel Burkhoff, Petr Ostadal, Richard Rokyta, Jan Belohlavek, Steffen Massberg, Marcus Flather, Matthias Hochadel, Steffen Schneider, Steffen Desch, Anne Freund, Hans Eiskjær, Norman Mangner, Janine Pöss, Amin Polzin, P Christian Schulze, Carsten Skurk, Uwe Zeymer, Christian Hassager
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引用次数: 0

摘要

背景:经皮主动机械循环支持(MCS)装置越来越多地用于急性心肌梗死相关性心源性休克(AMICS)的治疗,尽管有关其对死亡率影响的证据相互矛盾。我们旨在确定早期常规主动经皮 MCS 与对照治疗对 AMICS 患者 6 个月全因死亡率的影响:在这项患者个体数据荟萃分析中,通过查询电子数据库 MEDLINE(通过 PubMed)、Cochrane Central Register of Controlled Trials(对照试验中央注册)和 Embase 以及 ClinicalTrials.gov(截至 2024 年 1 月 26 日),确定了可能感兴趣的随机对照试验,没有语言限制。研究纳入了所有随机试验,这些试验提供了 AMICS 患者 6 个月的死亡率数据,比较了早期常规积极 MCS(随机化后直接在导管室进行)与对照试验。主要结果是接受早期常规主动经皮MCS治疗的AMICS患者的6个月全因死亡率,重点是设备类型(加载,如静脉体外膜肺氧合[VA-ECMO]与非加载)和患者选择。主要结局指标的危险比(HRs)采用 Cox 回归模型进行计算。本研究已在 PROSPERO 注册,编号为 CRD42024504295:详细评估了九项随机对照试验报告(n=1114 名患者)。总体而言,四项随机对照试验(样本数=611名患者)将VA-ECMO与对照治疗进行了比较,五项随机对照试验(样本数=503名患者)将左心室负重装置与对照治疗进行了比较。两项随机对照试验还包括未接受AMICS治疗的患者,这些患者被排除在外(55名患者[44名接受VA-ECMO治疗,11名接受左心室负荷装置治疗])。患者年龄中位数为 65 岁(IQR 57-73);在有数据的 1058 例患者中,845 例(79-9%)为男性,213 例(20-1%)为女性。早期使用非选择性 MCS 对 6 个月死亡率无明显益处(HR 0-87 [95% CI 0-74-1-03];P=0-10)。左心室卸载装置与对照组相比无明显差异(0-80 [0-62-1-02];P=0-075),加载装置对死亡率也无影响(0-93 [0-75-1-17];P=0-55)。无缺氧性脑损伤风险的ST段抬高型心源性休克患者使用MCS后死亡率降低(0-77 [0-61-0-97];P=0-024)。与对照组相比,使用 MCS 时大出血(几率比 2-64 [95% CI 1-91-3-65])和血管并发症(4-43 [2-37-8-26])的发生率更高:AMICS患者使用主动MCS装置并不能降低6个月死亡率(无论使用何种装置),反而会增加大出血和血管并发症。然而,ST 段抬高型心源性休克患者在使用 MCS 后死亡率有所降低,但无缺氧性脑损伤风险。因此,MCS 的使用应仅限于某些患者:莱比锡大学莱比锡心脏中心和 Herzinfarktforschung 基金会。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Temporary mechanical circulatory support in infarct-related cardiogenic shock: an individual patient data meta-analysis of randomised trials with 6-month follow-up.

Background: Percutaneous active mechanical circulatory support (MCS) devices are being increasingly used in the treatment of acute myocardial infarction-related cardiogenic shock (AMICS) despite conflicting evidence regarding their effect on mortality. We aimed to ascertain the effect of early routine active percutaneous MCS versus control treatment on 6-month all-cause mortality in patients with AMICS.

Methods: In this individual patient data meta-analysis, randomised controlled trials of potential interest were identified, without language restriction, by querying the electronic databases MEDLINE via PubMed, Cochrane Central Register of Controlled Trials, and Embase, as well as ClinicalTrials.gov, up to Jan 26, 2024. All randomised trials with 6-month mortality data comparing early routine active MCS (directly in the catheterisation laboratory after randomisation) versus control in patients with AMICS were included. The primary outcome was 6-month all-cause mortality in patients with AMICS treated with early routine active percutaneous MCS versus control, with a focus on device type (loading, such as venoarterial extracorporeal membrane oxygenation [VA-ECMO] vs unloading) and patient selection. Hazard ratios (HRs) of the primary outcome measure were calculated using Cox regression models. This study is registered with PROSPERO, CRD42024504295.

Findings: Nine reports of randomised controlled trials (n=1114 patients) were evaluated in detail. Overall, four randomised controlled trials (n=611 patients) compared VA-ECMO with a control treatment and five randomised controlled trials (n=503 patients) compared left ventricular unloading devices with a control treatment. Two randomised controlled trials also included patients who did not have AMICS, who were excluded (55 patients [44 who were treated with VA-ECMO and 11 who were treated with a left ventricular unloading device]). The median patient age was 65 years (IQR 57-73); 845 (79·9%) of 1058 patients with data were male and 213 (20·1%) were female. No significant benefit of early unselected MCS use on 6-month mortality was noted (HR 0·87 [95% CI 0·74-1·03]; p=0·10). No significant differences were observed for left ventricular unloading devices versus control (0·80 [0·62-1·02]; p=0·075), and loading devices also had no effect on mortality (0·93 [0·75-1·17]; p=0·55). Patients with ST-elevation cardiogenic shock without risk of hypoxic brain injury had a reduction in mortality with MCS use (0·77 [0·61-0·97]; p=0·024). Major bleeding (odds ratio 2·64 [95% CI 1·91-3·65]) and vascular complications (4·43 [2·37-8·26]) were more frequent with MCS use than with control.

Interpretation: The use of active MCS devices in patients with AMICS did not reduce 6-month mortality (regardless of the device used) and increased major bleeding and vascular complications. However, patients with ST-elevation cardiogenic shock without risk of hypoxic brain injury had a reduction in mortality after MCS use. Therefore, the use of MCS should be restricted to certain patients only.

Funding: The Heart Center Leipzig at Leipzig University and the Foundation Institut für Herzinfarktforschung.

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来源期刊
The Lancet
The Lancet 医学-医学:内科
CiteScore
148.10
自引率
0.70%
发文量
2220
审稿时长
3 months
期刊介绍: The Lancet is a world-leading source of clinical, public health, and global health knowledge. It was founded in 1823 by Thomas Wakley and has been an independent, international weekly general medical journal since then. The journal has an Impact Factor of 168.9, ranking first among 167 general and internal medicine journals globally. It also has a Scopus CiteScore of 133·2, ranking it second among 830 general medicine journals. The Lancet's mission is to make science widely available to serve and transform society, positively impacting people's lives. Throughout its history, The Lancet has been dedicated to addressing urgent topics, initiating debate, providing context for scientific research, and influencing decision makers worldwide.
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