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Journal of neurosurgery · May 2023
Randomized Controlled TrialEndovascular treatment of brain arteriovenous malformations: clinical outcomes of patients included in the registry of a pragmatic randomized trial.
- Jean Raymond, Jean-Christophe Gentric, Elsa Magro, Lorena Nico, Emma Bacchus, Ruby Klink, Christophe Cognard, Anne-Christine Januel, Jean-François Sabatier, Daniela Iancu, Alain Weill, Daniel Roy, Michel W Bojanowski, Chiraz Chaalala, Xavier Barreau, Vincent Jecko, Chrysanthi Papagiannaki, Stéphane Derrey, Eimad Shotar, Philippe Cornu, Omer F Eker, Isabelle Pelissou-Guyotat, Michel Piotin, Sorin Aldea, Rémy Beaujeux, François Proust, René Anxionnat, Vincent Costalat, CorreMarine LeML23Neurosurgery, CHU Montpellier, France., Jean-Yves Gauvrit, Xavier Morandi, Hervé Brunel, Pierre-Hugues Roche, Thomas Graillon, Emmanuel Chabert, Denis Herbreteau, Hubert Desal, Denis Trystram, Charlotte Barbier, Thomas Gaberel, Thanh N Nguyen, Geraldine Viard, Guylaine Gevry, Tim E Darsaut, TOBAS Collaborative Group, and Collaborators in the TOBAS Collaborative Group .
- 1Department of Radiology, Service of Neuroradiology, Centre hospitalier de l'Université de Montréal (CHUM), and CHUM Research Centre, Montréal, Québec, Canada.
- J. Neurosurg. 2023 May 1; 138 (5): 139314021393-1402.
ObjectiveThe role of endovascular treatment in the management of patients with brain arteriovenous malformations (AVMs) remains uncertain. AVM embolization can be offered as stand-alone curative therapy or prior to surgery or stereotactic radiosurgery (SRS) (pre-embolization). The Treatment of Brain AVMs Study (TOBAS) is an all-inclusive pragmatic study that comprises two randomized trials and multiple registries.MethodsResults from the TOBAS curative and pre-embolization registries are reported. The primary outcome for this report is death or dependency (modified Rankin Scale [mRS] score > 2) at last follow-up. Secondary outcomes include angiographic results, perioperative serious adverse events (SAEs), and permanent treatment-related complications leading to an mRS score > 2.ResultsFrom June 2014 to May 2021, 1010 patients were recruited in TOBAS. Embolization was chosen as the primary curative treatment for 116 patients and pre-embolization prior to surgery or SRS for 92 patients. Clinical and angiographic outcomes were available in 106 (91%) of 116 and 77 (84%) of 92 patients, respectively. In the curative embolization registry, 70% of AVMs were ruptured, and 62% were low-grade AVMs (Spetzler-Martin grade I or II), while the pre-embolization registry had 70% ruptured AVMs and 58% low-grade AVMs. The primary outcome of death or disability (mRS score > 2) occurred in 15 (14%, 95% CI 8%-22%) of the 106 patients in the curative embolization registry (4 [12%, 95% CI 5%-28%] of 32 unruptured AVMs and 11 [15%, 95% CI 8%-25%] of 74 ruptured AVMs) and 9 (12%, 95% CI 6%-21%) of the 77 patients in the pre-embolization registry (4 [17%, 95% CI 7%-37%] of 23 unruptured AVMs and 5 [9%, 95% CI 4%-20%] of 54 ruptured AVMs) at 2 years. Embolization alone was confirmed to occlude the AVM in 32 (30%, 95% CI 21%-40%) of the 106 curative attempts and in 9 (12%, 95% CI 6%-21%) of 77 patients in the pre-embolization registry. SAEs occurred in 28 of the 106 attempted curative patients (26%, 95% CI 18%-35%, including 21 new symptomatic hemorrhages [20%, 95% CI 13%-29%]). Five of the new hemorrhages were in previously unruptured AVMs (n = 32; 16%, 95% CI 5%-33%). Of the 77 pre-embolization patients, 18 had SAEs (23%, 95% CI 15%-34%), including 12 new symptomatic hemorrhages [16%, 95% CI 9%-26%]). Three of the hemorrhages were in previously unruptured AVMs (3/23; 13%, 95% CI 3%-34%).ConclusionsEmbolization as a curative treatment for brain AVMs was often incomplete. Hemorrhagic complications were frequent, even when the specified intent was pre-embolization before surgery or SRS. Because the role of endovascular treatment remains uncertain, it should preferably, when possible, be offered in the context of a randomized trial.
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