The ARUBA Trial randomized patients with unruptured arteriovenous malformations (AVM) to medical management versus multi-modal therapy. As published in the Lancet, the Data Safety and Monitoring Board (DSMB) prematurely halted the trial at 223 patients (55% enrollment) due to inferior outcomes in the interventional treatment arm. Mean follow up was 33 months. Though combined treatment with radiosurgery, endovascular or surgical treatment was permitted by trial design, many of the 114 patients randomized to the interventional arm underwent embolization alone (30 patients), radiosurgery alone (31 patients) or no therapy (20 patients) at trial stoppage. The combined primary endpoint of stroke or death was reached by 11 patients in the medical arm (10.1%) versus 35 patients in the surgical arm (30.7%) [HR 0.27; 95% CI 0.14-0.54]. These results were driven by the high rates of AVM rupture and ischemic stroke in the interventional arm (21.9% and 7.9%); mortality was comparable between the two groups.
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