Extracorporeal Life Support in Infarct-Related Cardiogenic Shock

医学 四分位间距 心源性休克 心肌梗塞 相对风险 体外 随机化 外科 置信区间 冲程(发动机) 随机对照试验 内科学 机械工程 工程类
作者
Holger Thiele,Uwe Zeymer,İbrahim Akın,Michael Behnes,Tienush Rassaf,Amir A. Mahabadi,Ralf Lehmann,Ingo Eitel,Tobias Graf,Tim Seidler,Andreas Schuster,Carsten Skurk,Daniel Duerschmied,Peter Clemmensen,Marcus Hennersdorf,Stephan Fichtlscherer,Ingo Voigt,Melchior Seyfarth,Stefan John,Sebastian Ewen,Axel Linke,Eike Tigges,Peter Nordbeck,Leonhard Bruch,Christian Jung,Jutta Franz,Philipp Lauten,Tomaž Goslar,Hans‐Josef Feistritzer,Janine Pöss,Eva Kirchhof,Taoufik Ouarrak,Steffen Schneider,Steffen Desch,Anne Freund
出处
期刊:The New England Journal of Medicine [New England Journal of Medicine]
卷期号:389 (14): 1286-1297 被引量:129
标识
DOI:10.1056/nejmoa2307227
摘要

Extracorporeal life support (ECLS) is increasingly used in the treatment of infarct-related cardiogenic shock despite a lack of evidence regarding its effect on mortality.In this multicenter trial, patients with acute myocardial infarction complicated by cardiogenic shock for whom early revascularization was planned were randomly assigned to receive early ECLS plus usual medical treatment (ECLS group) or usual medical treatment alone (control group). The primary outcome was death from any cause at 30 days. Safety outcomes included bleeding, stroke, and peripheral vascular complications warranting interventional or surgical therapy.A total of 420 patients underwent randomization, and 417 patients were included in final analyses. At 30 days, death from any cause had occurred in 100 of 209 patients (47.8%) in the ECLS group and in 102 of 208 patients (49.0%) in the control group (relative risk, 0.98; 95% confidence interval [CI], 0.80 to 1.19; P = 0.81). The median duration of mechanical ventilation was 7 days (interquartile range, 4 to 12) in the ECLS group and 5 days (interquartile range, 3 to 9) in the control group (median difference, 1 day; 95% CI, 0 to 2). The safety outcome consisting of moderate or severe bleeding occurred in 23.4% of the patients in the ECLS group and in 9.6% of those in the control group (relative risk, 2.44; 95% CI, 1.50 to 3.95); peripheral vascular complications warranting intervention occurred in 11.0% and 3.8%, respectively (relative risk, 2.86; 95% CI, 1.31 to 6.25).In patients with acute myocardial infarction complicated by cardiogenic shock with planned early revascularization, the risk of death from any cause at the 30-day follow-up was not lower among the patients who received ECLS therapy than among those who received medical therapy alone. (Funded by the Else Kröner Fresenius Foundation and others; ECLS-SHOCK ClinicalTrials.gov number, NCT03637205.).
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