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Abstract
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.
ClinicalTrials.gov 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.
GLOSSARY
- ARUBA=
- A Randomized Trial of Unruptured Brain Arteriovenous Malformations;
- AVM=
- arteriovenous malformation;
- CI=
- confidence interval;
- DSMB=
- Data and Safety Monitoring Board;
- HR=
- hazard ratio;
- IQR=
- interquartile range;
- IT=
- interventional therapy;
- MM=
- medical management;
- mRS=
- modified Rankin Scale;
- NINDS=
- National Institute of Neurological Disorders and Stroke;
- S-MG=
- Spetzler-Martin grade
Footnotes
Coinvestigators are listed at Neurology.org.
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
The data presented here were a platform presentation at the 68th annual meeting of the American Academy of Neurology, April 16, 2016, Vancouver, Canada, in Session S7, Stroke Clinical Trials, “Clinical Impairment in Patients Followed With or Without Interventional Therapy in a Randomized Trial of Unruptured Brain AVMs (ARUBA).”
Supplemental data at Neurology.org
- Received September 13, 2016.
- Accepted in final form June 13, 2017.
- © 2017 American Academy of Neurology
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