Clinical Impairment in Patients Followed With or Without Interventional Therapy in a Randomized Trial of Unruptured Brain Avms (aruba)

Background and Purpose A Randomized trial of Unruptured Brain Arteriovenous malformations (ARUBA) compared outcome of unbled brain AVMs with medical management with and without interventional treatment. Follow-up data and pre-specified secondary analyses are presented which assessed functional impairment after primary outcome events by treatment group and by Spetzler-Martin grade. Methods We examined functional impairment defined by the modified Rankin scale score (mRS ≥2) at the time of primary outcome (death or stroke), and compared the frequency of such functional impairment and its association with both the Spetzler-Martin Grade and primary outcome events by treatment group. Analyses were performed both by “as randomized” (intention to treat) and “as treated”. Results After a median of 42 months of follow-up, the median post-primary outcome event mRS for those ‘as randomized’ to medical management (MM) was 2 (IQR: 1,4) versus 3 (IQR: 1,5) in the interventional therapy (IT) arm. Values for those ‘as treated’ in MM were 1 (IQR: 1,5) versus IT 4 (IQR: 2,5). As measured by mRS ≥2, the risk of functional impairment, after a primary outcome event was significantly lower (HR 0.26. 95[percnt]CI 0.12-0.57) for patients ‘as randomized’ to MM compared to IT, and even lower for those ‘as treated’ (HR 0.09, 95[percnt]CI 0.03-0.27). Spetzler-Martin Grade and primary outcome events were not associated in the medical arm (p=0.80) but were so with increasing grades in the interventional arm (p=0.0002). Conclusion In ARUBA, death or stroke with a significant increase in functional impairment was more common for patients undergoing preventive intervention compared to those randomized to medical management. Outcome events were both far less frequent and of lower severity for those having no intervention, irrespective of the Spetzler-Martin Grades, Disclosure: Dr. Mohr has nothing to disclose. Dr. Overbey has nothing to disclose. Dr. Stapf has nothing to disclose. Dr. Hartmann has nothing to disclose. Dr. Stefani has nothing to disclose. Dr. Parides has nothing to disclose. Dr. Moquete has nothing to disclose. Dr. Moy has nothing to disclose. Dr. Vicaut has nothing to disclose. Dr. Moskowitz has nothing to disclose. Dr. Al-Shahi Salman has nothing to disclose. Dr. Houdart has nothing to disclose. Dr. Cordonnier has nothing to disclose. Dr. von Kummer has nothing to disclose. Dr. Biondi has nothing to disclose. Dr. Berkefeld has nothing to disclose. Dr. Klijn has nothing to disclose. Dr. Harkness has nothing to disclose. Dr. Libman has nothing to disclose. Dr. Barreau has nothing to disclose. Dr. Kim has nothing to disclose.