ARUBA trial

ARUBA Trial Summary

Objective

The ARUBA (A Randomized trial of Unruptured Brain Arteriovenous malformations) trial aimed to compare the risk of death and symptomatic stroke in patients with unruptured brain arteriovenous malformations (AVMs) managed with medical management alone versus medical management combined with interventional therapy (neurosurgery, embolization, or stereotactic radiotherapy).

Methods

• Design: Multicenter, non-blinded, randomized controlled trial.
• Participants: 226 adults with unruptured brain AVMs were enrolled from 39 clinical sites in nine countries.
• Randomization: Patients were randomized 1:1 to either medical management alone or medical management with interventional therapy.
• Outcome Measures: The primary outcome was time to death or symptomatic stroke.

Results

• Primary Endpoint: The trial was halted early due to the superiority of medical management alone. At a mean follow-up of 33.3 months, 11 patients (10.1%) in the medical management group reached the primary endpoint versus 35 patients (30.7%) in the interventional therapy group. The hazard ratio was 0.27 (95% CI 0.14–0.54).
• Adverse Events: Strokes and neurological deficits unrelated to stroke were significantly higher in the interventional therapy group.

Conclusion

Medical management alone was found to be superior to interventional therapy for the prevention of death or stroke in patients with unruptured brain AVMs over a mean follow-up of 33 months. These results suggest that medical management should be preferred, and the trial continues with an observational phase to assess long-term outcomes.

Funding

The trial was funded by the National Institutes of Health (NIH) and the National Institute of Neurological Disorders and Stroke (NINDS).

Reference

Mohr JP, Parides MK, Stapf C, et al. Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial. Lancet 2014; 383: 614–21.