Abstract
Endovascular embolization only has been advocated for treatment of brain arteriovenous malformations in recent trials. Our aim was to evaluate the results of embolization only in a cohort of patients who were enrolled in the A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA) study at 39 clinical sites in 9 countries. We analyzed the rates and severity of stroke and death in patients who underwent embolization only. Events were identified through in-person neurologic follow-up visits performed at 6-month intervals during the first 2 years and annually, with telephone contact every 6 months thereafter. All event-related data were reviewed by independent adjudicators. Among 30 patients who had embolization planned, 26 underwent embolization only. A total of 13 stroke events were reported in the follow-up period among 26 subjects (ischemic, hemorrhagic, or both in 4, 7, and 2 subjects, respectively). The adverse event occurred after the first embolization in 11 of 13 patients. One patient had a major motor deficit, and 2 patients developed major visual field deficits. One event was fatal. The modified Rankin Scale score was 0-2 at last follow-up in 11 of the 12 stroke survivors. Estimated stroke-free survival was 46% at 12 months. Although the rates of stroke and/or death were high in patients treated with embolization only in ARUBA, the rates of favorable outcomes following stroke were high during follow-up.
Highlights
BACKGROUND AND PURPOSEEndovascular embolization only has been advocated for treatment of brain arteriovenous malformations in recent trials
For 114 patients allocated to interventional therapy, brain arteriovenous malformations were treated by neurosurgery alone (n = 5), embolization alone (n = 30), or radiation therapy alone (n = 31) or using a multimodal approach (n = 28)
The study was discontinued after the Data and Safety Monitoring Board appointed by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health recommended halting randomization because the composite end point of death or symptomatic stroke had occurred in 10.1% patients in the medical management group compared with 30.7% in the interventional therapy group, which exceeded the prespecified stopping boundary
Summary
Our aim was to evaluate the results of embolization only in a cohort of patients who were enrolled in the A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA) study at 39 clinical sites in 9 countries
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