A Randomized Trial of Intravenous Alteplase before Endovascular Treatment for Stroke.
Aged
Aged, 80 and over
Combined Modality Therapy
Endovascular Procedures
Europe
Female
Fibrinolytic Agents
/ therapeutic use
Humans
Infusions, Intravenous
Ischemic Stroke
/ drug therapy
Male
Middle Aged
Severity of Illness Index
Thrombectomy
Tissue Plasminogen Activator
/ therapeutic use
Treatment Outcome
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:
11 11 2021
11 11 2021
Historique:
entrez:
10
11
2021
pubmed:
11
11
2021
medline:
25
11
2021
Statut:
ppublish
Résumé
The value of administering intravenous alteplase before endovascular treatment (EVT) for acute ischemic stroke has not been studied extensively, particularly in non-Asian populations. We performed an open-label, multicenter, randomized trial in Europe involving patients with stroke who presented directly to a hospital that was capable of providing EVT and who were eligible for intravenous alteplase and EVT. Patients were randomly assigned in a 1:1 ratio to receive EVT alone or intravenous alteplase followed by EVT (the standard of care). The primary end point was functional outcome on the modified Rankin scale (range, 0 [no disability] to 6 [death]) at 90 days. We assessed the superiority of EVT alone over alteplase plus EVT, as well as noninferiority by a margin of 0.8 for the lower boundary of the 95% confidence interval for the odds ratio of the two trial groups. Death from any cause and symptomatic intracerebral hemorrhage were the main safety end points. The analysis included 539 patients. The median score on the modified Rankin scale at 90 days was 3 (interquartile range, 2 to 5) with EVT alone and 2 (interquartile range, 2 to 5) with alteplase plus EVT. The adjusted common odds ratio was 0.84 (95% confidence interval [CI], 0.62 to 1.15; P = 0.28), which showed neither superiority nor noninferiority of EVT alone. Mortality was 20.5% with EVT alone and 15.8% with alteplase plus EVT (adjusted odds ratio, 1.39; 95% CI, 0.84 to 2.30). Symptomatic intracerebral hemorrhage occurred in 5.9% and 5.3% of the patients in the respective groups (adjusted odds ratio, 1.30; 95% CI, 0.60 to 2.81). In a randomized trial involving European patients, EVT alone was neither superior nor noninferior to intravenous alteplase followed by EVT with regard to disability outcome at 90 days after stroke. The incidence of symptomatic intracerebral hemorrhage was similar in the two groups. (Funded by the Collaboration for New Treatments of Acute Stroke consortium and others; MR CLEAN-NO IV ISRCTN number, ISRCTN80619088.).
Sections du résumé
BACKGROUND
The value of administering intravenous alteplase before endovascular treatment (EVT) for acute ischemic stroke has not been studied extensively, particularly in non-Asian populations.
METHODS
We performed an open-label, multicenter, randomized trial in Europe involving patients with stroke who presented directly to a hospital that was capable of providing EVT and who were eligible for intravenous alteplase and EVT. Patients were randomly assigned in a 1:1 ratio to receive EVT alone or intravenous alteplase followed by EVT (the standard of care). The primary end point was functional outcome on the modified Rankin scale (range, 0 [no disability] to 6 [death]) at 90 days. We assessed the superiority of EVT alone over alteplase plus EVT, as well as noninferiority by a margin of 0.8 for the lower boundary of the 95% confidence interval for the odds ratio of the two trial groups. Death from any cause and symptomatic intracerebral hemorrhage were the main safety end points.
RESULTS
The analysis included 539 patients. The median score on the modified Rankin scale at 90 days was 3 (interquartile range, 2 to 5) with EVT alone and 2 (interquartile range, 2 to 5) with alteplase plus EVT. The adjusted common odds ratio was 0.84 (95% confidence interval [CI], 0.62 to 1.15; P = 0.28), which showed neither superiority nor noninferiority of EVT alone. Mortality was 20.5% with EVT alone and 15.8% with alteplase plus EVT (adjusted odds ratio, 1.39; 95% CI, 0.84 to 2.30). Symptomatic intracerebral hemorrhage occurred in 5.9% and 5.3% of the patients in the respective groups (adjusted odds ratio, 1.30; 95% CI, 0.60 to 2.81).
CONCLUSIONS
In a randomized trial involving European patients, EVT alone was neither superior nor noninferior to intravenous alteplase followed by EVT with regard to disability outcome at 90 days after stroke. The incidence of symptomatic intracerebral hemorrhage was similar in the two groups. (Funded by the Collaboration for New Treatments of Acute Stroke consortium and others; MR CLEAN-NO IV ISRCTN number, ISRCTN80619088.).
Identifiants
pubmed: 34758251
doi: 10.1056/NEJMoa2107727
doi:
Substances chimiques
Fibrinolytic Agents
0
Tissue Plasminogen Activator
EC 3.4.21.68
Banques de données
ISRCTN
['ISRCTN80619088']
Types de publication
Equivalence Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1833-1844Subventions
Organisme : Hartstichting
ID : CVON2015-01: CONTRAST
Organisme : Hersenstichting
ID : HA2015.01.06
Organisme : Health~Holland
ID : LSHM17016
Investigateurs
Yvo Roos
(Y)
Charles Majoie
(C)
Kilian Treurniet
(K)
Jonathan Coutinho
(J)
Bart Emmer
(B)
Natalie LeCouffe
(N)
Manon Kappelhof
(M)
Leon Rinkel
(L)
Agnetha Bruggeman
(A)
Bob Roozenbeek
(B)
Adriaan van Es
(A)
Inger de Ridder
(I)
Wim van Zwam
(W)
Bart van der Worp
(B)
Rob Lo
(R)
Koos Keizer
(K)
Rob Gons
(R)
Lonneke Yo
(L)
Jelis Boiten
(J)
Ido van den Wijngaard
(I)
Geert Lycklama À Nijeholt
(G)
Jeannette Hofmeijer
(J)
Jasper Martens
(J)
Wouter Schonewille
(W)
Jan Albert Vos
(JA)
Anil Tuladhar
(A)
Floris Schreuder
(F)
Jeroen Boogaarts
(J)
Sjoerd Jenniskens
(S)
Karlijm de Laat
(K)
Lukas van Dijk
(L)
Hellen den Hertog
(H)
Boudewijn van Hasselt
(B)
Paul Brouwers
(P)
Emiel Sturm
(E)
Tomas Bulut
(T)
Michel Remmers
(M)
Anouk van Norden
(A)
Thijs de Jong
(T)
Anouk Rozeman
(A)
Otto Elgersma
(O)
Maarten Uyttenboogaart
(M)
Reinoud Bokkers
(R)
Julia van Tuijl
(J)
Issam Boukrab
(I)
Hans Kortman
(H)
Vincent Costalat
(V)
Caroline Arquizan
(C)
Robin Lemmens
(R)
Jelle Demeestere
(J)
Philippe Desfontaines
(P)
Denis Brisbois
(D)
Frédéric Clarençon
(F)
Yves Samson
(Y)
Diederik Dippel
(D)
Aad van der Lugt
(A)
Kilian Treurniet
(K)
Martin Brown
(M)
Phil White
(P)
John Gregson
(J)
Daan Nieboer
(D)
Rick van Nuland
(R)
Alida Postma
(A)
René van den Berg
(R)
Ludo Beenen
(L)
Pieter Jan van Doormaal
(PJ)
Geert Lycklama
(G)
Albert Yoo
(A)
Bas Hammer
(B)
Stefan Roosendaal
(S)
Anton Meijer
(A)
Menno Krietemeijer
(M)
Anouk van der Hoorn
(A)
Dick Gerrits
(D)
Robert van Oosternbrugge
(R)
Ben Jansen
(B)
Sanne Manschot
(S)
Henk Kerkhof
(H)
Peter Koudstaal
(P)
Hester Lingsma
(H)
Vicky Chalos
(V)
Olvert Berkhemer
(O)
Adriaan Versteeg
(A)
Lennard Wolff
(L)
Jiahang Su
(J)
Manon Tolhuisen
(M)
Henk van Voorst
(H)
Hugo Ten Cate
(H)
Moniek de Maat
(M)
Samantha Donse-Donkel
(S)
Heleen van Beusekom
(H)
Aladdin Taha
(A)
Sophie van den Berg
(S)
Rob van de Graaf
(R)
Robert-Jan Goldhoorn
(RJ)
Wouter Hinsenveld
(W)
Anne Pirson
(A)
Lotte Sondag
(L)
Rik Reinink
(R)
Josje Brouwer
(J)
Matthijs van der Sluijs
(M)
Sabine Collette
(S)
Wouter van der Steen
(W)
Miou Koopman
(M)
Rita Sprengers
(R)
Martin Sterrenberg
(M)
Naziha El Ghannouti
(N)
Sabrina Verheesen
(S)
Wilma Pellikaan
(W)
Kitty Blauwendraat
(K)
Yvonne Drabbe
(Y)
Joke de Meris
(J)
Michelle Simons
(M)
Hester Bongenaar
(H)
Anja van Loon
(A)
Eva Ponjee
(E)
Rieke Eilander
(R)
Jasmijn Lodico
(J)
Hanneke Droste
(H)
Suze Kooij
(S)
Marieke de Jong
(M)
Esther Santegoets
(E)
Suze Roodenburg
(S)
Ayla van Ahee
(A)
Marinette Moynier
(M)
Annemie Devroye
(A)
Evelyn Marcelis
(E)
Ingrid Iezzi
(I)
Annie David
(A)
Atika Talbi
(A)
Leontien Heiligers
(L)
Yvonne Martens
(Y)
N E LeCouffe
(NE)
M Kappelhof
(M)
K M Treurniet
(KM)
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2021 Massachusetts Medical Society.