Trial of Thrombectomy for Stroke with a Large Infarct of Unrestricted Size.
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:
09 May 2024
09 May 2024
Historique:
medline:
8
5
2024
pubmed:
8
5
2024
entrez:
8
5
2024
Statut:
ppublish
Résumé
The use of thrombectomy in patients with acute stroke and a large infarct of unrestricted size has not been well studied. We assigned, in a 1:1 ratio, patients with proximal cerebral vessel occlusion in the anterior circulation and a large infarct (as defined by an Alberta Stroke Program Early Computed Tomographic Score of ≤5; values range from 0 to 10) detected on magnetic resonance imaging or computed tomography within 6.5 hours after symptom onset to undergo endovascular thrombectomy and receive medical care (thrombectomy group) or to receive medical care alone (control group). The primary outcome was the score on the modified Rankin scale at 90 days (scores range from 0 to 6, with higher scores indicating greater disability). The primary safety outcome was death from any cause at 90 days, and an ancillary safety outcome was symptomatic intracerebral hemorrhage. A total of 333 patients were assigned to either the thrombectomy group (166 patients) or the control group (167 patients); 9 were excluded from the analysis because of consent withdrawal or legal reasons. The trial was stopped early because results of similar trials favored thrombectomy. Approximately 35% of the patients received thrombolysis therapy. The median modified Rankin scale score at 90 days was 4 in the thrombectomy group and 6 in the control group (generalized odds ratio, 1.63; 95% confidence interval [CI], 1.29 to 2.06; P<0.001). Death from any cause at 90 days occurred in 36.1% of the patients in the thrombectomy group and in 55.5% of those in the control group (adjusted relative risk, 0.65; 95% CI, 0.50 to 0.84), and the percentage of patients with symptomatic intracerebral hemorrhage was 9.6% and 5.7%, respectively (adjusted relative risk, 1.73; 95% CI, 0.78 to 4.68). Eleven procedure-related complications occurred in the thrombectomy group. In patients with acute stroke and a large infarct of unrestricted size, thrombectomy plus medical care resulted in better functional outcomes and lower mortality than medical care alone but led to a higher incidence of symptomatic intracerebral hemorrhage. (Funded by Montpellier University Hospital; LASTE ClinicalTrials.gov number, NCT03811769.).
Sections du résumé
BACKGROUND
BACKGROUND
The use of thrombectomy in patients with acute stroke and a large infarct of unrestricted size has not been well studied.
METHODS
METHODS
We assigned, in a 1:1 ratio, patients with proximal cerebral vessel occlusion in the anterior circulation and a large infarct (as defined by an Alberta Stroke Program Early Computed Tomographic Score of ≤5; values range from 0 to 10) detected on magnetic resonance imaging or computed tomography within 6.5 hours after symptom onset to undergo endovascular thrombectomy and receive medical care (thrombectomy group) or to receive medical care alone (control group). The primary outcome was the score on the modified Rankin scale at 90 days (scores range from 0 to 6, with higher scores indicating greater disability). The primary safety outcome was death from any cause at 90 days, and an ancillary safety outcome was symptomatic intracerebral hemorrhage.
RESULTS
RESULTS
A total of 333 patients were assigned to either the thrombectomy group (166 patients) or the control group (167 patients); 9 were excluded from the analysis because of consent withdrawal or legal reasons. The trial was stopped early because results of similar trials favored thrombectomy. Approximately 35% of the patients received thrombolysis therapy. The median modified Rankin scale score at 90 days was 4 in the thrombectomy group and 6 in the control group (generalized odds ratio, 1.63; 95% confidence interval [CI], 1.29 to 2.06; P<0.001). Death from any cause at 90 days occurred in 36.1% of the patients in the thrombectomy group and in 55.5% of those in the control group (adjusted relative risk, 0.65; 95% CI, 0.50 to 0.84), and the percentage of patients with symptomatic intracerebral hemorrhage was 9.6% and 5.7%, respectively (adjusted relative risk, 1.73; 95% CI, 0.78 to 4.68). Eleven procedure-related complications occurred in the thrombectomy group.
CONCLUSIONS
CONCLUSIONS
In patients with acute stroke and a large infarct of unrestricted size, thrombectomy plus medical care resulted in better functional outcomes and lower mortality than medical care alone but led to a higher incidence of symptomatic intracerebral hemorrhage. (Funded by Montpellier University Hospital; LASTE ClinicalTrials.gov number, NCT03811769.).
Identifiants
pubmed: 38718358
doi: 10.1056/NEJMoa2314063
doi:
Banques de données
ClinicalTrials.gov
['NCT03811769']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1677-1689Investigateurs
Xavier Ayrignac
(X)
Caroline Arquizan
(C)
Mahmoud Charif
(M)
Vincent Costalat
(V)
Lucas Corti
(L)
Cyril Dargazanli
(C)
Imad Derraz
(I)
Nicolas Gaillard
(N)
Grégory Gascou
(G)
Pierre-Henri Lefevre
(PH)
Anaïs Lippi
(A)
Isabelle Mourand
(I)
Pauline Prin
(P)
Perrine Schmitt
(P)
Florian Savenier
(F)
Adrien Ter Schiphorst
(A)
Pierre Briau
(P)
Igor Sibon
(I)
Florent Gariel
(F)
Gaultier Marnat
(G)
Jean-Sébastien Liegey
(JS)
Malgorzata Milnerowicz
(M)
Jean Papaxanthos
(J)
Lisa Papillon
(L)
Alice Corfu
(A)
Sophie Godard
(S)
Jean-Baptiste Girot
(JB)
Anne Pasco-Papon
(A)
Vincent L'Allinec
(V)
Alderic Lecluse
(A)
Nadeem Beydoun
(N)
Matthias Lamy
(M)
Samy Boucebci
(S)
Stéphane Velasco
(S)
Victor Dumas
(V)
Cédric Fauche
(C)
Jean-Philippe Neau
(JP)
Paola Palazzo
(P)
Nicolas Raynaud
(N)
Agnès Aghetti
(A)
Emmanuel Houdart
(E)
Anna Dimitrovic
(A)
Mikael Mazighi
(M)
Alexis Gueden
(A)
Peggy Reiner
(P)
Wagih Benhassen
(W)
Olivier Naggara
(O)
Basile Kerleroux
(B)
Guillaume Turc
(G)
Christine Rodriguez Regent
(C)
Julien Allard
(J)
Frédéric Clarencon
(F)
Flore Baronnet
(F)
Sonia Alamowitch
(S)
Sophie Crozier
(S)
Stephen Delorme
(S)
Sandrine Deltour
(S)
Gaspard Gerschenfeld
(G)
Anne Leger
(A)
Kevin Premat
(K)
Charlotte Rosso
(C)
Yves Samson
(Y)
Eimad Shotar
(E)
Jildaaz Caroff
(J)
Laurent Spelle
(L)
Vanessa Chalumeau
(V)
Olivier Chassin
(O)
Sophie Gallas
(S)
Léon Ikka
(L)
Nicolas Legris
(N)
Mariana Sarov Riviere
(M)
Laura Venditti
(L)
Christian Denier
(C)
René Anxionnat
(R)
Mathieu Bonnerot
(M)
Liang Liao
(L)
Nolwenn Riou-Comte
(N)
Benjamin Gory
(B)
Sébastien Richard
(S)
Pierre-Louis Alexandre
(PL)
Benjamin Daumas-Duport
(B)
Hubert Desal
(H)
Lili Detraz
(L)
Cécile Preterre
(C)
Romain Bourcier
(R)
Benoît Guillon
(B)
Valérie Wolff
(V)
Raoul Pop
(R)
Laura Baptiste
(L)
Pierre-Olivier Comby
(PO)
Brivael Lemogne
(B)
Pierre Thouant
(P)
Yannick Bejot
(Y)
Frédéric Ricolfi
(F)
François-Mathias Merrien
(FM)
Lorena Nico
(L)
Julien Ognard
(J)
Laurina Simoni
(L)
Jean-Christophe Gentric
(JC)
Serge Timsit
(S)
Aude Triquenot Bagan
(A)
Chrysanthi Papagiannaki
(C)
Ozlem Ozkul
(O)
Pierre Seners
(P)
Michel Piotin
(M)
Michael Obadia
(M)
Marie Bodenant
(M)
Nicolas Bricout
(N)
Barbara Casolla
(B)
Nelly Dequatre
(N)
Lucie Della Shiava
(L)
Maco Pasi
(M)
François Caparros
(F)
Laurent Puy
(L)
Arnaud Karam
(A)
Olfa Kaaouana
(O)
Kaelig Watel
(K)
Giuseppe Scopelliti
(G)
Nasreddine Nouri
(N)
Hilde Henon
(H)
Richard Bibi
(R)
Arnaud Bretonniere
(A)
Marie Gaudron
(M)
Denis Herbreteau
(D)
Héloise Ifergan
(H)
Kevin Jannot
(K)
Elisabeth Molinier
(E)
Mariam Annan
(M)
Grégoire Boulouis
(G)
Emmanuel Wiener
(E)
Audrey Arnoux Courselle
(A)
Sandrine Canaple
(S)
Elisa Ouin
(E)
Cyril Chivot
(C)
Chantal Lamy
(C)
Suzana Saleme
(S)
Charbel Mounayer
(C)
Francisco Macian Montoro
(F)
Morgane Laubacher
(M)
Roberto Riva
(R)
Omer Eker
(O)
Tae-Hee Cho
(TH)
Lionel Calviere
(L)
Louis Fontaine
(L)
Jean-Marc Olivot
(JM)
Nicolas Raposo
(N)
Alain Viguier
(A)
Christophe Cognard
(C)
Jean-François Albucher
(JF)
Emilie Doche
(E)
Nadia Laksiri
(N)
Stephanie Machado
(S)
Ophelie Osman
(O)
Roxane Peres
(R)
Emanuelle Robinet
(E)
Caroline Rey
(C)
Laurent Suissa
(L)
Hervé Brunel
(H)
Federico Di Maria
(F)
Bertrand Lapergue
(B)
Elie Lteif
(E)
Emmanuel Chabert
(E)
Anna Ferrier
(A)
Lara Blanca
(L)
Helena Quesada
(H)
Ana Núñez
(A)
Andrés Paipa
(A)
Pere Cardona
(P)
Alejandro Bustamante
(A)
Laura Dorado Bouix
(L)
Christopher Calib
(C)
Jaime Carbonell
(J)
Gema Eugenia Garcia Amor
(GE)
Garbiñe Ezcurra
(G)
Belén Flores
(B)
Manuel Gómez Choco
(M)
Meritxell Gomis Cortina
(M)
María Hernández Pérez
(M)
Marina Hernández
(M)
Clara Larrañaga
(C)
Manuel Domínguez Lizarbe
(M)
Marina Martínez
(M)
Alex Menéndez Albarracín
(A)
Natalia Pérez de la Ossa
(N)
Neus Rabaneda
(N)
Anna Ramos Pachón
(A)
Luis Alejandro Rodríguez
(LA)
Sara Rubio
(S)
Isabel Puig
(I)
Daniel Santana
(D)
Adrian Valls
(A)
Barbara Yugueros
(B)
Denisse Wenger
(D)
Mònica Millán
(M)
Sergio Amaro
(S)
Mircea Balasa
(M)
Jose Maria Cabrera
(JM)
Ángel Chamorro
(Á)
Estefania Conde
(E)
Jose Miguel Contador
(JM)
Antonio Doncel-Mariano
(A)
Arturo Renú
(A)
Mar Guasp
(M)
Laura Llansó
(L)
Laura Llull
(L)
Gerard Mayà Casalprim
(G)
Carmen Montejo
(C)
Alejandro Rodríguez
(A)
Salvatore Rudilosso
(S)
Almudena Sánchez
(A)
Daniel Santana
(D)
Xabier Urra Nuin
(XU)
Victor Augusto Vera Monge
(VA)
Mercedes De Lera
(M)
María Esther Ramos
(ME)
Garazi Aguirre
(G)
Laura Cabral
(L)
Irene Díaz
(I)
Alejandro Durán Lozano
(A)
Alain Luna
(A)
Jon Martín
(J)
Ana Moreno Estébanez
(A)
Walter Sifontes
(W)
Iratxe Ugarriza
(I)
Lorena Benavente
(L)
Sergio Calleja Puerta
(S)
María Castañón Apilánez
(M)
Álvaro Criado
(Á)
David Fuentes
(D)
Carmen García-Cabo
(C)
Montserrat González Delgado
(M)
Gemma María González
(GM)
Javier Molina Gil
(J)
Davinia Larrosa Campo
(D)
Begoña López López
(B)
Antía Reguera Acuña
(A)
María Rico Santos
(M)
Patricia Zunzunegui
(P)
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