Patient Selection in a Pragmatic Study on the Management of Patients with Brain Arteriovenous Malformations

医学 随机对照试验 放射外科 栓塞 动静脉畸形 外科 颅内动静脉畸形 随机化 血管造影 脑血管造影 放射治疗
作者
Jean Raymond,Anass Benomar,Jean‐Christophe Gentric,Elsa Magro,Lorena Nico,Emma Bacchus,Ruby Klink,Daniela Iancu,Alain Weill,Daniel Roy,Michel W. Bojanowski,Chiraz Chaalala,Omer Eker,I. Pélissou-Guyotat,Michel Piotin,Sorin Aldéa,Charlotte Barbier,Thomas Gaberel,Chrysanthi Papagiannaki,S. Derrey,Thanh N. Nguyen,Mohamad Abdalkader,Christophe Cognard,Anne-Christine Januel,Jean-François Sabatier,Vincent Jecko,Xavier Barreau,Vincent Costalat,Vincent Costalat,Marine Le Corre,Marine Le Corre,Chrysanthi Papagiannaki,Xavier Morandi,Xavier Morandi,Alessandra Biondi,Alessandra Biondi,L. Thines,L. Thines,Hubert Desal,Hubert Desal,Romain Bourcier,Rémy Beaujeux,Rémy Beaujeux,F. Proust,F. Proust,Geraldine Viard,Guylaine Gevry,T.E. Darsaut,T.E. Darsaut,Cian O’Kelly,Michael Chow,J. Max Findlay,Jeremy Rempel,Robert Fahed,Howard Lesiuk,Brian Drake,Marlene Dos Santos,Michel Nonent,Julien Ognard,Mourad Cheddad El-Aouni,Romuald Seizeur,Serge Timsit,Olivier Pradier,Romain Boursier,F. Thillays,Vincent Roualdes,Raphaël Blanc,Lionel Calviere,J.–Y. Gauvrit,Hélène Raoult,François Eugene,Anthony Le Bras,Jean-Christophe Ferré,Christophe Paya,Isabelle Lecouillard,Elodie Nouhaud,Thomas Ronzière,D. Trystram,Olivier Naggara,Christine Rodriguez-Régent,Basile Kerleroux,Évelyne Emery,Emmanuel Touze,Roberto Riva,Isabelle Pellisou-Guyotat,Jacques Guyotat,Monsef Berhouma,Chloé Dumot,Nassim Bougaci,Guillaume Charbonnier,Serge Bracard,René Anxionnat,Benjamin Gory,Thierry Civit,Valérie Bernier-Chastagner,Gaultier Marnat,Guillaume Penchet,Edouard Gimbert,A. Huchet,Denis Herbreteau,Grégoire Boulouis,Richard Bibi,Héloïse Ifergan,Kévin Janot,Stéphane Velut,H. Brunel,Pièrre-Hugues Roche,Thomas Graillon,Hadrien Peyriere,Jean-Marc Kaya,Adamou Touta,Lucas Troude,Sébastien Boissonneau,Frédéric Clarençon,Eimad Shotar,Nader Sourour,Stéphanie Lenck,Kévin Premat,Anne‐Laure Boch,Philippe Cornu,Aurélien Nouet,Alain Bonafé,Cyril Dargazanli,Grégory Gascou,Pierre-Henri Lefevre,Carlos Riquelme,Raoul Pop,Hélène Cebula,Irène Ollivier,Giorgio Spatola,Laurent Spell,Vanessa Chalumeau,Sophie Gallas,Léon Ikka,Cristian Mihalea,Augustin Ozanne,Jildaz Caroff,Emmanuel Chabert,Charbel Mounayer,Aymeric Rouchaud,François Caire,F. Ricolfi,Pierre Thouant,Catherine Cao,Klaus-Luc Mourier,Walid Farah,Thien Huynh,Rabih G. Tawk,Andrew P. Carlson,Luciana Alves Oliveira Silva,Nayara de Lima Froio,Gisele Sampaio Silva,Francisco Mont’alverne,Jose Luri Martins,George Nunes Mendes,Rodrigo Rivera Miranda
出处
期刊:World Neurosurgery [Elsevier BV]
卷期号:172: e611-e624
标识
DOI:10.1016/j.wneu.2023.01.098
摘要

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.
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