ARUBA
Trial question
What is the role of medical management in patients with unruptured brain AVMs?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
41.0% female
59.0% male
N = 223
223 patients (92 female, 131 male)
Inclusion criteria: adult patients with an unruptured brain AVM
Key exclusion criteria: imaging evidence of previous hemorrhage from a brain AVM; previous interventional treatment attempt; presence of a brain AVM deemed unsuitable for attempted eradication
Interventions
N=109 medical management (pharmacotherapy for neurological symptoms as needed)
N=114 intervention therapy (medical management with neurosurgery, embolization, or stereotactic radiotherapy alone or in combination)
Primary outcome
Death or symptomatic stroke
10.1
30.7
30.7 %
23.0 %
15.3 %
7.7 %
0.0 %
Medical management
Intervention therapy
Significant decrease ▼
NNT = 4
Significant decrease in death or symptomatic stroke (10.1% vs. 30.7%; HR 0.27, 95% CI 0.14 to 0.54)
Secondary outcomes
No significant difference in death (1.8% vs. 2.6%; RR 0.7, 95% CI 0.12 to 4.09)
Borderline significant decrease in first stroke (8.3% vs. 29.8%; RR 0.28, 95% CI 0.14 to 0.55)
Borderline significant decrease in hemorrhagic stroke (5.5% vs. 21.9%; RR 0.25, 95% CI 0.11 to 0.59)
Safety outcomes
No significant differences in seizure, headache, infection.
Significant differences in stroke (0.039% per patient-year vs. 0.144% per patient-year), focal deficit unrelated to stroke (0.003% per patient-year vs. 0.045% per patient-year).
Conclusion
In adult patients with an unruptured brain AVM, medical management was superior to intervention therapy with respect to death or symptomatic stroke.
Reference
J P Mohr, Michael K Parides, Christian Stapf et al. Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial. Lancet. 2014 Feb 15;383(9917):614-21.
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