Medical management with interventional therapy versus medical management alone for unruptured brain arteriovenous malformations (ARUBA)
Final follow-up of a multicenter, non-blinded, randomized controlled trial
- Randomized trial following patients with unruptured arteriovenous malformations (AVMs). Control group received best medical management alone, treatment group had medical management plus neurosurgical resection, endovascular embolization, stereotactic radiosurgery, or some combination of the above.
- Inclusion criteria were patients age ≥18 years diagnosed with an unruptured brain AVM who had never received intervention but were suitable for intervention to eradicate the AVM.
- Total of 226 patients enrolled (of 1740 screened) at 39 international centers
- Primary outcome was death or symptomatic stroke, occurring in 15 of 110 medical management patients vs 41 of 116 patients in the intervention arm with a hazard ratio of 0.31 with 95%CI 0.17-0.56, favoring medical management alone.
- Secondary outcome was death or disability (mRS 2) at 5 years after randomization. Data for this was available for 96 patients, criteria were met in 9 of 51 in the medical management group and 17 of 45 in the intervention group.
- Adverse events (stroke, focal deficits unrelated to stroke, seizures, headaches) were reported as 283 events in the medical management group and 369 events in the intervention group, with risk difference -19.76 with 95% CI -30.33 to -9.19, favoring medical management alone.
- Randomization for the ARUBA trial was halted at mean follow-up of 33.3 months after prespecified interim analysis showed superiority of medical management alone. This paper provides longer follow-up data (mean 50 months) to show persistence of this difference.
Lancet Neurol 2020