Medical Management With or Without Interventional Therapy for Unruptured Brain Arteriovenous Malformations (ARUBA): A Multicentre, Non-Blinded, Randomised Trial

Study Questions:

What is the clinical benefit of preventive eradication of unruptured brain arteriovenous malformations?

Methods:

ARUBA (A Randomised trial of Unruptured Brain Arteriovenous malformations) was a randomized trial that compared the risk of death and symptomatic stroke in patients with an unruptured brain arteriovenous malformation who were allocated to either medical management alone or medical management with interventional therapy. Adult patients with an unruptured brain arteriovenous malformation were enrolled at 39 clinical sites in nine countries. Patients were randomized to medical management with interventional therapy (i.e., neurosurgery, embolization, or stereotactic radiotherapy, alone or in combination) or medical management alone (i.e., pharmacological therapy for neurological symptoms as needed). The primary outcome was time to the composite endpoint of death or symptomatic stroke.

Results:

The study was stopped prematurely on recommendations of the Data and Safety Monitoring Board appointed by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health because of superiority of the medical management group. At that point, outcome data were available for 223 patients (mean follow-up 33.3 months), of whom 114 were assigned to interventional therapy and 109 to medical management. The risk of death or stroke was significantly lower in the medical management group than in the interventional therapy group (10.1 % vs. 30.7%; hazard ratio, 0.27; 95% confidence interval, 0.14-0.54). Patients randomized to interventional therapy had a higher number of strokes (45 vs. 12, p < 0.0001) and neurological deficits unrelated to stroke (14 vs. 1, p = 0.0008) compared to medical management.

Conclusions:

Medical management alone is superior to medical management with interventional therapy for the prevention of death or stroke in patients with unruptured brain arteriovenous malformations.

Perspective:

The increasing use of computed tomography and magnetic resonance imaging has resulted in an increased detection of unruptured arteriovenous malformations in the brain. The appropriate treatment of these lesions is unclear, and this study provides clear evidence to support lack of benefit from routine prophylactic interventional care. The outcome of patients on medical therapy is still less than ideal, and better strategies are needed to reduce the risk of stroke in this population.

Clinical Topics: Vascular Medicine

Keywords: Stroke, Neurosurgery, National Institute of Neurological Disorders and Stroke, Clinical Trials Data Monitoring Committees, West Indies, Intracranial Arteriovenous Malformations, United States, Brain


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