The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research.
OBJECTIVE The management of brain arteriovenous malformations (bAVMs) remains controversial. The Treatment of Brain AVMs Study (TOBAS) was designed to manage patients with bAVMs within a clinical research framework. The objective of this study was to study trial feasibility, recruitment rates, patient allocation to the various management groups, and compliance with treatment allocation. METHODS TOBAS combines two randomized care trials (RCTs) and a registry. Designed to be all-inclusive, the study offers randomized allocation of interventional versus conservative management to patients eligible for both options (first RCT), a second RCT testing the role of preembolization as an adjunct to surgery or radiotherapy, and a registry of patients managed using clinical judgment alone. The primary outcome of the first RCT is death from any cause or disabling stroke (modified Rankin Scale score > 2) at 10 years. A pilot phase was initiated at one center to test study feasibility, record the number and characteristics of patients enrolled in the RCTs, and estimate the frequency of crossovers. RESULTS All patients discussed at the multidisciplinary bAVM committee between June 2014 and June 2016 (n = 107) were recruited into the study; 46 in the randomized trials (23 in the first RCT with 21 unruptured bAVMs, 40 in the second RCT with 17 unruptured bAVMs, and 17 in both RCTs), and 61 patients in the registry. Three patients crossed over from surgery to observation (first RCT). CONCLUSIONS Clinical research was successfully integrated with normal practice using TOBAS. Recruitment rates in a single center are encouraging. Whether the trial will provide meaningful results depends on the recruitment of a sufficient number of participating centers. Clinical trial registration no.: NCT02098252 (clinicaltrials.gov).
['Magro|Elsa|E|', 'Gentric|Jean-Christophe|JC|', 'Batista|André Lima|AL|', 'Kotowski|Marc|M|', 'Chaalala|Chiraz|C|', 'Roberge|David|D|', 'Weill|Alain|A|', 'Stapf|Christian|C|', 'Roy|Daniel|D|', 'Bojanowski|Michel W|MW|', 'Darsaut|Tim E|TE|', 'Klink|Ruby|R|', 'Raymond|Jean|J|']
D000293:Adolescent D000328:Adult D000368:Aged D000369:Aged, 80 and over D002648:Child D002986:Clinical Trials as Topic D000072700:Conservative Treatment D019468:Disease Management D004621:Embolization, Therapeutic D005260:Female D006801:Humans D002538:Intracranial Arteriovenous Malformations D008297:Male D008875:Middle Aged D019635:Neurosurgical Procedures D010349:Patient Compliance D018579:Patient Selection D011446:Prospective Studies D016032:Randomized Controlled Trials as Topic D012042:Registries D012107:Research Design D020521:Stroke D016896:Treatment Outcome D055815:Young Adult
brain arteriovenous malformation care trial randomized trial AVM = arteriovenous malformation CHUM = Centre Hospitalier de l’Université de Montréal RCT = randomized care trial TOBAS = Treatment of Brain AVMs Study bAVM = brain AVM mRS = modified Rankin Scale ruptured AVM unruptured AVM vascular disorders