体外生命支持在与梗死相关的心原性休克中的应用。
Extracorporeal Life Support in Infarct-Related Cardiogenic Shock.
机构信息
From Heart Center Leipzig at University of Leipzig (H.T., H.-J.F., J.P., S.D., A.F.) and Helios Health Institute (E.K.), Leipzig, Institut für Herzinfarktforschung (U.Z., T.O., S.S.) and Klinikum Ludwigshafen (U.Z.), Ludwigshafen, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim (I.A., M.B., D.D.), the West German Heart and Vascular Center, University Hospital Essen (T.R., A.A.M.), and Contilia Elisabeth-Krankenhaus, Essen (I.V.), Essen, Asklepios Clinic Langen, Langen (R.L.), University Heart Center Lübeck and German Center for Cardiovascular Research, Partner Site Hamburg-Kiel-Lübeck, Lübeck (I.E., T. Graf), Heart Center Göttingen, University Medicine Göttingen, Göttingen (T.S., A.S.), Deutsches Herzzentrum der Charité, Department of Cardiology, Angiology and Intensive Care Medicine (C.S.), and Unfallkrankenhaus Berlin (L.B.), Berlin, University Heart and Vascular Center Hamburg (P.C.) and Asklepios Clinic St. Georg (E.T.), Hamburg, SLK Kliniken Heilbronn, Heilbronn (M.H.), University Heart and Vascular Center Frankfurt, Frankfurt (S.F.), Heart Center Wuppertal, Witten-Herdecke University, Wuppertal (M.S.), Paracelsus Private University, Clinic Nuremberg South, Nuremberg (S.J.), Saarland University Medical Center and Saarland University Faculty of Medicine, Homburg (S.E.), Technische Universität Dresden, Heart Center, Dresden (A.L.), University Clinic Würzburg, Würzburg (P.N.), University Clinic Düsseldorf, Düsseldorf (C.J.), Clinic Winnenden, Winnenden (J.F.), and Zentralklinik Bad Berka, Bad Berka (P.L.) - all in Germany; and University Medical Center Ljubljana, Ljubljana, Slovenia (T. Goslar).
出版信息
N Engl J Med. 2023 Oct 5;389(14):1286-1297. doi: 10.1056/NEJMoa2307227. Epub 2023 Aug 26.
BACKGROUND
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.
METHODS
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.
RESULTS
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).
CONCLUSIONS
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.).
背景
尽管体外生命支持（ECLS）在治疗与梗死相关的心源性休克方面的效果缺乏证据，但它的应用正在增加。
方法
在这项多中心试验中，计划早期血运重建的急性心肌梗死合并心源性休克患者被随机分为接受早期 ECLS 加常规药物治疗（ECLS 组）或单纯常规药物治疗（对照组）。主要结局是 30 天的任何原因死亡。安全性结局包括出血、卒中和需要介入或手术治疗的外周血管并发症。
结果
共有 420 例患者接受随机分组，417 例患者纳入最终分析。30 天时，ECLS 组 209 例患者中有 100 例（47.8%）死亡，对照组 208 例患者中有 102 例（49.0%）死亡（相对风险，0.98；95%置信区间 [CI]，0.80 至 1.19；P=0.81）。ECLS 组机械通气中位时间为 7 天（四分位距，4 至 12），对照组为 5 天（四分位距，3 至 9）（中位差异，1 天；95%CI，0 至 2）。ECLS 组中 23.4%的患者发生中度或重度出血，对照组中 9.6%的患者发生中度或重度出血（相对风险，2.44；95%CI，1.50 至 3.95）；需要介入治疗的外周血管并发症分别为 11.0%和 3.8%（相对风险，2.86；95%CI，1.31 至 6.25）。
结论
在计划早期血运重建的急性心肌梗死合并心源性休克患者中，接受 ECLS 治疗的患者与接受单纯药物治疗的患者相比，30 天随访时的任何原因死亡风险并没有降低。（由 Else Kröner Fresenius 基金会等资助；ECLS-SHOCK ClinicalTrials.gov 编号，NCT03637205）。
Zotero 插件