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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: 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: 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: Patients included in the RCTs differ significantly from registry patients. Meaningful results can be obtained if multiple centers actively participate in the TOBAS RCTs., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Intracranial aneurysms (IAs) can be treated through endovascular treatment (EVT) or microsurgery (MS). Treated IAs can recanalize, which can lead to rupture or retreatment., Objective: The aim of our study was to evaluate the natural history of previously treated IA, by evaluating the risk of rupture and the risk of retreatment., Methods: All patients treated for an IA between 2007 and 2017 in 4 hospitals were included. The rate of (recurrent) hemorrhage and the rate of prophylactic retreatment were retrospectively evaluated. Kaplan-Meier survival analysis with log-rank tests was used to compare the rates of rupture or retreatment. Patients with ruptured and unruptured aneurysms were separated, and we compared the risk of retreatment between EVT and the surgical treatment., Results: A total of 4997 IAs were included in the study, corresponding to 20,489 patient-years. Overall, 28 (0.6%) aneurysms that had been previously treated demonstrated hemorrhage. Moreover, 237 (4.7%) aneurysms were retreated for recanalization without hemorrhage. The rate of retreatment was higher in the EVT-treated IAs as compared with the MS-treated IAs (LogRank: P < 0.0001) and higher in the previously ruptured IAs versus unruptured IAs (LogRank: P < 0.0001). However, the rate of posttreatment hemorrhage/IA rupture was similar for both groups., Conclusions: The rate of IA retreatment is low; however, the rate of hemorrhage/rupture from treated IAs is even lower. A higher rate of retreatment was noted in EVT-treated IAs versus MS-treated IAs and in ruptured IAs versus unruptured IAs; however, the rate of hemorrhage or rerupture was comparable between the groups., (Copyright © 2021 Elsevier Inc. All rights reserved.)