Extracorporeal Life Support in Infarct-Related Cardiogenic Shock.
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
05 Oct 2023
05 Oct 2023
Historique:
pubmed:
27
8
2023
medline:
27
8
2023
entrez:
27
8
2023
Statut:
ppublish
Résumé
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.).
Sections du résumé
BACKGROUND
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
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
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
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.).
Identifiants
pubmed: 37634145
doi: 10.1056/NEJMoa2307227
doi:
Banques de données
ClinicalTrials.gov
['NCT03637205']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1286-1297Subventions
Organisme : Else Kröner-Fresenius-Stiftung
ID : Nr. 2018_A102
Organisme : Deutsche Herzstiftung
ID : F/10/18
Investigateurs
Holger Thiele
(H)
Steffen Desch
(S)
Uwe Zeymer
(U)
Anne Freund
(A)
Steffen Schneider
(S)
Eva Kirchhof
(E)
Taoufik Ouarrak
(T)
Tobias Müller
(T)
Kurt Huber
(K)
Karl Werdan
(K)
Tim Friede
(T)
Ibrahim Akin
(I)
Michael Behnes
(M)
Daniel Duerschmied
(D)
Janine Pöss
(J)
Hans-Josef Feistritzer
(HJ)
Tienush Rassaf
(T)
Amir Abbas Mahabadi
(AA)
Ralf Lehmann
(R)
Marcus Mittag
(M)
Tobias Graf
(T)
Georg Fuernau
(G)
Roza Saraei
(R)
Ingo Eitel
(I)
Tim Seidler
(T)
Andreas Schuster
(A)
Ulf Landmesser
(U)
Carsten Skurk
(C)
Peter Clemmensen
(P)
Benedikt Schrage
(B)
Stefan Blankenberg
(S)
Marcus Hennersdorf
(M)
Dominik Scharpf
(D)
Stephan Fichtlscherer
(S)
Stephan Heyl
(S)
Ingo Voigt
(I)
Thomas Schmitz
(T)
Melchior Seyfarth
(M)
Marc Vorpahl
(M)
Stefan John
(S)
Matthias Pauschinger
(M)
Sebastian Ewen
(S)
Felix Mahfoud
(F)
Michael Böhm
(M)
Axel Linke
(A)
Felix Woitek
(F)
Norman Mangner
(N)
Eike Tigges
(E)
Felix Meincke
(F)
Stephan Willems
(S)
Nele Gessner
(N)
Samer Hakmi
(S)
Peter Nordbeck
(P)
Stefan Frantz
(S)
Leonhard Bruch
(L)
Ralf Zahn
(R)
Christian Jung
(C)
Malte Kelm
(M)
Jutta Franz
(J)
Harald Lapp
(H)
Philipp Lauten
(P)
Holger Nef
(H)
Oliver Doerr
(O)
Tobias Wengenmeyer
(T)
Dawid Staudacher
(D)
Dirk Westermann
(D)
Wolfgang Rottbauer
(W)
P Christian Schulze
(PC)
Sven Möbius-Winkler
(S)
Stephan Baldus
(S)
Christoph Adler
(C)
Ulrich Laufs
(U)
Karsten Lenk
(K)
Alexander Lauten
(A)
Helge Möllmann
(H)
Johannes Blumenstein
(J)
Stephan B Felix
(SB)
Peter Abel
(P)
Alper Öner
(A)
Hüseyin Ince
(H)
Markus Ferrari
(M)
Benjamin Schempf
(B)
Christoph Kadel
(C)
Daniel Bock
(D)
Maren Weferling
(M)
Christian Hamm
(C)
Marco Noc
(M)
Tomaz Goslar
(T)
Peter Boekstegers
(P)
Lars S Maier
(LS)
Thomas Müller
(T)
Daniel Sedding
(D)
Jochen Dutzmann
(J)
Jörn Tongers
(J)
Alexander Bufe
(A)
Stefan Baumanns
(S)
Alexander Kersten
(A)
Nikolaus Marx
(N)
Michael Preusch
(M)
Norbert Frey
(N)
Informations de copyright
Copyright © 2023 Massachusetts Medical Society.