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Functional impairments for outcomes in a randomized trial of unruptured brain AVMs
J P Mohr1, Jessica R Overbey2, Ruediger von Kummer2
1From Columbia University Medical Center (J.P.M.); Icahn School of Medicine at Mount Sinai (J.R.O., M.K.P., E.M., A.J.M.), New York, NY; University Hospital Dresden (R.v.K.), Germany; Federal University of Rio Grande do Sul (M.A.S.), Porto Alegre, Brazil; North Shore-Long Island Jewish Medical Center (R.L.), New York, NY; University of Montreal (C.S.), Quebec, Canada; Winthrop University Hospital (J.P.-S.), Mineola, NY; National Institute of Neurological Disorders and Stroke (C.S.M.), NIH, Bethesda, MD; Hôpital Lariboisière (E.V., E.H.), Paris, France; Royal Hallamshire Hospital (K.H.), Sheffield, UK; Université Lille Nord de France (C.C.); University of Franche Comté (A.B), Besançon, France; Universitätsklinikum Frankfurt am Main (J.B.), Germany; Department of Neurology (C.J.M.K.), Donders Institute for Brain, Cognition and Behaviour, Center for Neuroscience, Radboud University Medical Center, Nijmegen, and Department of Neurology and Neurosurgery (C.J.M.K.), Brain Center Rudolf Magnus, University Medical Center, Utrecht, the Netherlands; CHU Pellegrin (X.B.), Bordeaux, France; University of California (H.K.), San Francisco; and Department of Neurology (A.H.), Klinikum Frankfurt (Oder), Germany. jpm10@columbia.edu.
Objective:
To investigate the effects of medical vs interventional management on functional outcome in A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA).
Methods:
We used the initial results of a nonblinded, randomized, controlled, parallel-group trial involving adults ≥18 years of age with an unruptured brain arteriovenous malformation (AVM) to compare the effects of medical management (MM) with or without interventional therapy (IT) on functional impairment, defined by a primary outcome of death or symptomatic stroke causing modified Rankin Scale (mRS) score ≥2. ARUBA closed recruitment on April 15, 2013.
Results:
After a median of 33.3 months of follow-up (interquartile range 16.3-49.8 months), of the 223 enrolled in the trial, those in the MM arm were less likely to experience primary outcomes with an mRS score ≥2 than those who underwent IT. The results applied for both those as randomized (MM n = 109 vs IT n = 114) (hazard ratio [HR] 0.25, 95% confidence interval [CI] 0.11-0.57, p = 0.001) and as treated (MM n = 125 vs IT n = 98) (HR 0.10, 95% CI 0.04-0.28, p < 0.001). Functional impairment for the outcomes showed no significant difference by Spetzler-Martin grade for MM but was more frequent with increasing grades for IT (p < 0.001).
Conclusion:
Death or stroke with functional impairment in ARUBA after a median follow-up of 33 months was significantly lower for those in the MM arm both as randomized and as treated compared with those with IT. Functional severity of outcomes was lower in the MM arm, regardless of Spetzler-Martin grades.
Clinicaltrialsgov Identifier:
NCT00389181.
Classification Of Evidence:
This study provides Class II evidence that for adults with unruptured brain AVMs, interventional management compared to MM increases the risk of disability and death over ≈3 years.
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