Abstract 189: ARUBA - A Randomised Trial Of Unruptured Brain Avms
RATIONALE: Current invasive treatment for brain arteriovenous malformations (AVMs) is varied and includes endovascular procedures, neurosurgery, and radiotherapy. However, no controlled treatment data for any comparison of treatments, immediate or deferred, on the benefit of preventive therapy for unruptured brain AVMs have yet been performed.
DESIGN: ARUBA is an international, multicenter, randomized, controlled, open, prospective clinical trial.
SAMPLE SIZE: 400 patients (1:1 random assignment).
POPULATION STUDIED: Patients aged ≥18 years, diagnosed with an unruptured brain AVM considered by the local investigators to be suitable for attempted eradication.
Outcome measures: The primary outcome is the composite event of death from any cause or stroke (hemorrhage or infarction confirmed by imaging). Clinical outcome status will be measured by the Rankin Scale, NIHSS, SF-36, and EuroQol.
INTERVENTIONS: Patients are randomly assigned to best possible invasive therapy (medical management plus endovascular, surgical, and/or radiation therapy ) versus medical management alone. Patients will be followed for 5-10 years from randomisation.
PRIMARY AIM: To determine whether a strategy of medical management alone is superior to invasive therapy for preventing the composite outcome of death from any cause or stroke (symptomatic haemorrhage or infarction) in the treatment of unruptured BAVMs.
SECONDARY AIM: To determine whether treatment of unruptured BAVMs by medical management alone decreases the risk of death or clinical impairment (Rankin Score >/= 2) at 5 years post-randomization compared to invasive therapy.
TRIAL STATUS: More than 200 patients have been enrolled worldwide.
SPONSOR: NIH/NINDS (NCT00389181)
CONTACT: firstname.lastname@example.org (www.arubastudy.org)
- © 2012 by American Heart Association, Inc.