Patient Selection in a Pragmatic Study on the Management of Patients with Brain Arteriovenous Malformations.
Brain arteriovenous malformation
Embolization
Pragmatic trials
Randomized trial
Journal
World neurosurgery
ISSN: 1878-8769
Titre abrégé: World Neurosurg
Pays: United States
ID NLM: 101528275
Informations de publication
Date de publication:
Apr 2023
Apr 2023
Historique:
received:
22
11
2022
revised:
24
01
2023
accepted:
25
01
2023
medline:
5
4
2023
pubmed:
5
2
2023
entrez:
4
2
2023
Statut:
ppublish
Résumé
The Treatment of Brain Arteriovenous Malformations Study (TOBAS) is an all-inclusive pragmatic study comprising 2 randomized clinical trials (RCTs). Patients excluded from the RCTs are followed in parallel treatment and observation registries, allowing a comparison between RCT and registry patients. The first randomized clinical trial (RCT-1) offers 1:1 randomized allocation of intervention versus conservative management for patients with arteriovenous malformation (AVM). The second randomized clinical trial (RCT-2) allocates 1:1 pre-embolization or no pre-embolization to surgery or radiosurgery patients judged treatable with or without embolization. Characteristics of RCT patients are reported and compared to registry patients. From June 2014 to May 2021, 1010 patients with AVM were recruited; 498 patients were observed and 373 were included in the treatment registries. Randomized allocation in RCT-1 was applied to 139 (26%) of the 512 patients (including 127 of 222 [57%] with unruptured AVMs) considered for curative treatment. RCT-1 AVM patients differed (in rupture status, Spetzler-Martin grade and baseline modified Rankin Score) from those in the observation or treatment registries (P < 0.001). Most patients had small (<3 cm; 71%) low-grade (Spetzler-Martin I-II; 64%) unruptured (91%) AVMs. The allocated management was conservative (n = 71) or curative (n = 68), using surgery (n = 39), embolization (n = 16), or stereotactic radiosurgery (n = 13). Pre-embolization was considered for 179/309 (58%) patients allocated/assigned to surgery or stereotactic radiosurgery; 87/179 (49%) were included in RCT-2. RCT-2 patient AVMs differed in size, eloquence and grade from patients of the pre-embolization registry (P < 0.01). Most had small (<3 cm in 82%) low-grade (83%) AVMs in non-eloquent brain (64%). Patients included in the RCTs differ significantly from registry patients. Meaningful results can be obtained if multiple centers actively participate in the TOBAS RCTs.
Sections du résumé
BACKGROUND
BACKGROUND
The Treatment of Brain Arteriovenous Malformations Study (TOBAS) is an all-inclusive pragmatic study comprising 2 randomized clinical trials (RCTs). Patients excluded from the RCTs are followed in parallel treatment and observation registries, allowing a comparison between RCT and registry patients.
METHODS
METHODS
The first randomized clinical trial (RCT-1) offers 1:1 randomized allocation of intervention versus conservative management for patients with arteriovenous malformation (AVM). The second randomized clinical trial (RCT-2) allocates 1:1 pre-embolization or no pre-embolization to surgery or radiosurgery patients judged treatable with or without embolization. Characteristics of RCT patients are reported and compared to registry patients.
RESULTS
RESULTS
From June 2014 to May 2021, 1010 patients with AVM were recruited; 498 patients were observed and 373 were included in the treatment registries. Randomized allocation in RCT-1 was applied to 139 (26%) of the 512 patients (including 127 of 222 [57%] with unruptured AVMs) considered for curative treatment. RCT-1 AVM patients differed (in rupture status, Spetzler-Martin grade and baseline modified Rankin Score) from those in the observation or treatment registries (P < 0.001). Most patients had small (<3 cm; 71%) low-grade (Spetzler-Martin I-II; 64%) unruptured (91%) AVMs. The allocated management was conservative (n = 71) or curative (n = 68), using surgery (n = 39), embolization (n = 16), or stereotactic radiosurgery (n = 13). Pre-embolization was considered for 179/309 (58%) patients allocated/assigned to surgery or stereotactic radiosurgery; 87/179 (49%) were included in RCT-2. RCT-2 patient AVMs differed in size, eloquence and grade from patients of the pre-embolization registry (P < 0.01). Most had small (<3 cm in 82%) low-grade (83%) AVMs in non-eloquent brain (64%).
CONCLUSIONS
CONCLUSIONS
Patients included in the RCTs differ significantly from registry patients. Meaningful results can be obtained if multiple centers actively participate in the TOBAS RCTs.
Identifiants
pubmed: 36738962
pii: S1878-8750(23)00114-6
doi: 10.1016/j.wneu.2023.01.098
pii:
doi:
Types de publication
Randomized Controlled Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e611-e624Investigateurs
Jean Raymond
(J)
Daniel Roy
(D)
Alain Weill
(A)
Daniela Iancu
(D)
Michel W Bojanowski
(MW)
Chiraz Chaalala
(C)
Tim E Darsaut
(TE)
Cian J O'Kelly
(CJ)
Michael Mc Chow
(MM)
J Max Findlay
(JM)
Jeremy L Rempel
(JL)
Robert Fahed
(R)
Howard Lesiuk
(H)
Brian Drake
(B)
Marlene Dos Santos
(MD)
Jean-Christophe Gentric
(JC)
Michel Nonent
(M)
Julien Ognard
(J)
Mourad Cheddad El-Aouni
(MC)
Elsa Magro
(E)
Romuald Seizeur
(R)
Serge Timsit
(S)
Olivier Pradier
(O)
Hubert Desal
(H)
Romain Boursier
(R)
François Thillays
(F)
Vincent Roualdes
(V)
Michel Piotin
(M)
Raphael Blanc
(R)
Sorin Aldea
(S)
Christophe Cognard
(C)
Anne-Christine Januel
(AC)
Jean-François Sabatier
(JF)
Lionel Calviere
(L)
Jean Yves Gauvrit
(JY)
Hélène Raoult
(H)
François Eugene
(F)
Anthony Le Bras
(A)
Jean-Christophe Ferre
(JC)
Christophe Paya
(C)
Xavier Morandi
(X)
Isabelle Lecouillard
(I)
Elodie Nouhaud
(E)
Thomas Ronziere
(T)
Denis Trystram
(D)
Olivier Naggara
(O)
Christine Rodriguez-Regent
(C)
Basile Kerleroux
(B)
Charlotte Barbier
(C)
Thomas Gaberel
(T)
Evelyne Emery
(E)
Emmanuel Touze
(E)
Chrysanthi Papagiannaki
(C)
Stéphane Derrey
(S)
Omer Eker
(O)
Roberto Riva
(R)
Isabelle Pellisou-Guyotat
(I)
Jacques Guyotat
(J)
Monsef Berhouma
(M)
Chloé Dumot
(C)
Alessandra Biondi
(A)
Laurent Thines
(L)
Nassim Bougaci
(N)
Guillaume Charbonnier
(G)
Serge Bracard
(S)
René Anxionnat
(R)
Benjamin Gory
(B)
Thierry Civit
(T)
Valérie Bernier-Chastagner
(V)
Xavier Barreau
(X)
Gaultier Marnat
(G)
Vincent Jecko
(V)
Guillaume Penchet
(G)
Edouard Gimbert
(E)
Aymeri Huchet
(A)
Denis Herbreteau
(D)
Grégoire Boulouis
(G)
Richard Bibi
(R)
Héloïse Ifergan
(H)
Kévin Janot
(K)
Stéphane Velut
(S)
Hervé Brunel
(H)
Pierre-Hugues Roche
(PH)
Thomas Graillon
(T)
Hadrien Peyriere
(H)
Jean-Marc Kaya
(JM)
Adamou Touta
(A)
Lucas Troude
(L)
Sébastien Boissonneau
(S)
Frédéric Clarençon
(F)
Eimad Shotar
(E)
Nader Sourour
(N)
Stéphanie Lenck
(S)
Kévin Premat
(K)
Anne-Laure Boch
(AL)
Philippe Cornu
(P)
Aurélien Nouet
(A)
Vincent Costalat
(V)
Alain Bonafe
(A)
Cyril Dargazanli
(C)
Gregory Gascou
(G)
Pierre-Henri Lefevre
(PH)
Carlos Riquelme
(C)
Marine Le Corre
(M)
Rémy Beaujeux
(R)
Raoul Pop
(R)
François Proust
(F)
Hélène Cebula
(H)
Irène Ollivier
(I)
Giorgio Spatola
(G)
Laurent Spell
(L)
Vanessa Chalumeau
(V)
Sophie Gallas
(S)
Léon Ikka
(L)
Cristian Mihalea
(C)
Augustin Ozanne
(A)
Jildaz Caroff
(J)
Emmanuel Chabert
(E)
Charbel Mounayer
(C)
Aymeric Rouchaud
(A)
François Caire
(F)
Frédéric Ricolfi
(F)
Pierre Thouant
(P)
Catherine Cao
(C)
Klaus-Luc Mourier
(KL)
Walid Farah
(W)
Thanh N Nguyen
(TN)
Mohamad Abdalkader
(M)
Thien Huynh
(T)
Rabih G Tawk
(RG)
Andrew P Carlson
(AP)
Luciana Alves Oliveira Silva
(LA)
Nayara de Lima Froio
(N)
Gisele Sampaio Silva
(GS)
Francisco J A Mont'Alverne
(FJA)
Jose Luri Martins
(JL)
George Nunes Mendes
(GN)
Rodrigo Rivera Miranda
(RR)
Informations de copyright
Copyright © 2023 Elsevier Inc. All rights reserved.