Treatment of Brain AVMs (TOBAS) Study: A Randomized Controlled Trial and Registry
Centre hospitalier de l'Université de Montréal (CHUM)
Summary
The objectives of this study and registry are to offer the best management possible for patients with brain arteriovenous malformations (AVMs) (ruptured or unruptured) in terms of long-term outcomes, despite the presence of uncertainty. Management may include interventional therapy (with endovascular procedures, neurosurgery, or radiotherapy, alone or in combination) or conservative management. The trial has been designed to test a) whether medical management or interventional therapy will reduce the risk of death or debilitating stroke (due to hemorrhage or infarction) by an absolute magnitude of about 15% (over 10 years) for unruptured AVMs (from 30% to 15%); and, b) to test if endovascular treatment can improve the safety and efficacy of surgery or radiation therapy by at least 10% (80% to 90%). As for the nested trial on the role of embolization in the treatment of Brain AVMs by other means: the pre-surgical or pre-radiosurgery embolization of cerebral AVMs can decrease the number of treatment failures from 20% to 10%. In addition,embolization of cerebral AVMs can be accomplished with an acceptable risk, defined as permanent disabling neurological complications of 8%.
Description
Intracranial arteriovenous malformations (AVMs) are relatively uncommon but increasingly discovered lesions that can lead to significant neurological disability or death.1 Population-based data suggest that the annual incidence of discovery of a symptomatic AVM is approximately 1.1 per 100 000 population.7. AVMs commonly present following an intracranial hemorrhage or seizure, although with contemporary brain imaging techniques, an increasing number of incidental lesions are found.2 Intracranial AVMs are typically diagnosed before the age of 40 years old, with more than 50% of patients presen…
Eligibility
- Age range
- 5+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Any patient with a brain AVM Exclusion Criteria: * Hemorrhagic presentation with mass effect requiring surgical management. In these cases, if a residual AVM is found after the initial surgery, the patient could then be a candidate for TOBAS.
Interventions
- ProcedureNeurosurgery
Surgical resection to be used when the lesion is considered by a multidisciplinary team to be safely 'operable'.
- RadiationRadiation therapy
when the AVM is smaller than 3 cm, and considered to not be safely 'operable'.
- ProcedureEmbolization
Curative embolization, when the lesion is considered curable by embolization.
Locations (30)
- Mayo Clinic in Jacksonville FLJacksonville, Florida
- Boston Medical CenterBoston, Massachusetts
- University of New Mexico Health Sciences CenterAlbuquerque, New Mexico
- Hospital Geral de FortalezaFortaleza
- Universidade Federal de Sǎo PauloSão Paulo
- University of Alberta HospitalEdmonton, Alberta