title: [Treatment of brain AVMS (TOBAS): A randomized controlled trial and registry].
abstract: OBJECTIVE
  The management of unruptured and ruptured brain arteriovenous malformations (AVMs) remains controversial. The Treatment of Brain AVM Study (TOBAS) was designed to assess curative treatments in the management of AVMs. The purpose of our study is to provide a care trial context to brain AVM patients.
  
  
  METHODS
  TOBAS is a pragmatic, prospective study including 2 randomized controlled trials and a registry. All AVM patients can be recruited. The preferred management modality will be predetermined prior to randomization by the team based on clinical judgment. Patients eligible for both conservative and interventional management will be randomly allocated conservative or curative treatment. Randomization will be stratified by a treatment modality (surgery, radiosurgery or embolization) and minimized according to a history of previous rupture and Spetzler-Martin grade. A second randomization will allocate eligible patients to embolization/no embolization prior to surgery or radiosurgery. The primary outcome of the study is death (any cause) or disabling stroke (mRS>2) at 10 years. All patients managed according to clinical judgment alone will be included in the registry. The study is registered under: wwwTrials.gov, ID: NCT02098252.
  
  
  RESULTS
  A minimum recruitment of 540 patients is required to show that treatment can reduce the primary outcome by 10 % (from 25 to 15 %); 440 patients will be needed to show a 10 % increase in angiographic occlusion for a good clinical outcome with pre-embolization.
  
  
  CONCLUSIONS
  The trial is designed to offer optimal and verifiable care to patients with brain AVMs in spite of the uncertainty. We are currently seeking the participation of multiple centers.
authors.affiliation: Centre hospitalier de l'université de Montréal (CHUM), Notre-Dame Hospital, Department of Surgery, Service of Neurosurgery, Montréal, Québec, Canada; Service de neurochirurgie, CHU Cavale Blanche, Inserm UMR 1101 LaTIM, Brest, France. Electronic address: elsa.magro@chu-brest.fr.
authors.forename: E
authors.initials: E
authors.lastname: Magro
authors.affiliation: Centre hospitalier de l'université de Montréal (CHUM), Notre-Dame Hospital, Department of Radiology, Service of Neuroradiology, 1560, Sherbrooke East, Pavillion Simard, Room Z12909, Montréal, Québec H2L 4M1, Canada; Service de radiologie, CHU Cavale Blanche, EA 3878 GETBO, Brest, France. Electronic address: jcgentric@gmail.com.
authors.forename: J-C
authors.initials: JC
authors.lastname: Gentric
authors.affiliation: University of Alberta Hospital, Mackenzie Health Sciences Centre, Department of Surgery, Division of Neurosurgery, Edmonton, Alberta, Canada. Electronic address: tdarsaut@ualberta.ca.
authors.forename: T E
authors.initials: TE
authors.lastname: Darsaut
authors.affiliation: Centre hospitalier de l'université de Montréal (CHUM), Notre-Dame Hospital, Department of Radiology, Service of Neuroradiology, 1560, Sherbrooke East, Pavillion Simard, Room Z12909, Montréal, Québec H2L 4M1, Canada. Electronic address: batistaneuro@bol.com.br.
authors.forename: A L
authors.initials: AL
authors.lastname: Batista
authors.affiliation: Centre hospitalier de l'université de Montréal (CHUM), Notre-Dame Hospital, Department of Surgery, Service of Neurosurgery, Montréal, Québec, Canada. Electronic address: chaalala@hotmail.com.
authors.forename: C
authors.initials: C
authors.lastname: Chaalala
authors.affiliation: Centre hospitalier de l'université de Montréal (CHUM), Notre-Dame Hospital, Department of Radio-Oncology, Montréal, Québec, Canada. Electronic address: drroberge@yahoo.com.
authors.forename: D
authors.initials: D
authors.lastname: Roberge
authors.affiliation: Centre hospitalier de l'université de Montréal (CHUM), Notre-Dame Hospital, Department of Radiology, Service of Neuroradiology, 1560, Sherbrooke East, Pavillion Simard, Room Z12909, Montréal, Québec H2L 4M1, Canada. Electronic address: alain.weill.chum@ssss.gouv.qc.ca.
authors.forename: A
authors.initials: A
authors.lastname: Weill
authors.affiliation: Centre hospitalier de l'université de Montréal (CHUM), Notre-Dame Hospital, Department of Radiology, Service of Neuroradiology, 1560, Sherbrooke East, Pavillion Simard, Room Z12909, Montréal, Québec H2L 4M1, Canada. Electronic address: daniel.roy.chum@ssss.gouv.qc.ca.
authors.forename: D
authors.initials: D
authors.lastname: Roy
authors.affiliation: Centre hospitalier de l'université de Montréal (CHUM), Notre-Dame Hospital, Department of Surgery, Service of Neurosurgery, Montréal, Québec, Canada. Electronic address: michel.bojanowski.chum@ssss.gouv.qc.ca.
authors.forename: M W
authors.initials: MW
authors.lastname: Bojanowski
authors.affiliation: Centre hospitalier de l'université de Montréal (CHUM), Notre-Dame Hospital, Department of Radiology, Service of Neuroradiology, 1560, Sherbrooke East, Pavillion Simard, Room Z12909, Montréal, Québec H2L 4M1, Canada. Electronic address: jean.raymond@umontreal.ca.
authors.forename: J
authors.initials: J
authors.lastname: Raymond
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D004621:Embolization, Therapeutic / Q000379:methods; D005260:Female; D006801:Humans; D002538:Intracranial Arteriovenous Malformations / Q000175:diagnosis / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000601:surgery; D011446:Prospective Studies; D012042:Registries; D016896:Treatment Outcome
keywords: Brain arteriovenous malformations; Malformation artério-veineuse cérébrale; Randomized controlled trial; Étude randomisée contrôlée