ARUBA Study Comments

Abstract

The only randomised study comparing active treatment (surgery, radiosurgery, endovascular treatment alone or in combination) with the best medical treatment of unruptured AVMs is the ARUBA study. The ARUBA study was performed on 223 patients in 39 centres across nine countries and was stopped prematurely after interim analysis in the sixth year because of the superiority of medical management over interventional treatment. The mean follow-up period was 33.3 months and the hazard ratio of stroke or death for patients randomised to medical treatment compared with patients randomised to interventional treatment was 0.27 (95% CI 0.14–0.54). From the results, the authors concluded the following:

“The ARUBA trial showed that medical management alone is superior to medical management with interventional therapy for the prevention of death or stroke in patients with unruptured brain arteriovenous malformations followed up for 33 months.”

This chapter includes comments and criticisms of main aspects of ARUBA study design, results and their interpretation such as lax criteria for site selection, recruitment bias, non-appropriateness of selected outcome measures, lack of standardisation of the treatment arm, insufficient length of follow-up and very low proportion of enrolled patients. Furthermore, literature review and meta-analysis of six post-ARUBA surgical series together with authors series is performed showing complication rate of 0.06 (95% CI 0.03–0.08) and efficacy of 0.98 (95% CI 0.97–0.99).

Finally, future directions of research and ongoing and future clinical studies on AVM treatment design and possible contribution to AVM treatment understanding is discussed.