Sponsor: NIH
Investigator: Thanh Nguyen MD (principal), Alexander Norbash MD, Carlos Kase MD, Viken Babikian MD, Jose Romero MD
NINDS Statement: For release: Thursday, May 9, 2013
Upon the recommendation of the ARUBA Data and Safety Monitoring Board, the NINDS has stopped enrollment of patient volunteers into the trial. Under the experimental conditions in this trial, the interim analysis of data collected to date shows that medical management is superior to intervention in patients with unruptured brain arteriovenous malformations (AVMs).
ARUBA was a randomized, multi-center trial designed to evaluate whether symptomatic medical management improves long-term outcomes of patients with unruptured brain arteriovenous malformations compared to invasive treatment for the composite event of death from any cause or symptomatic stroke (hemorrhage or infarction confirmed by imaging); a secondary outcome is disability as measured by the Rankin Score. Invasive treatment could include endovascular procedures, neurosurgery, or radiotherapy alone or in combination. The intent was to randomize 400 participants and follow them for 5 to 10 years; however, because of the higher than expected event rate in the interventional arm compared with medical management, the DSMB recommended stopping enrollment while continuing to follow all participants to determine whether the difference in stroke and death in the two arms changes over time.
Summary
An arteriovenous malformation (AVM) is a tangled bundle of abnormal arteries and veins that are directly connected to each other. In general, arteries carry fresh oxygen-filled blood from the heart and distribute it through fine and finer vessels (arterioles and capillaries) to all parts of the body to nourish the tissue. Veins bring the "used" blood back to the heart. In the case of an AVM, there is an absence of capillaries and the blood goes directly from an artery into a vein. The main risk of an AVM in the brain is the risk of sudden bleeding if the AVM ruptures. Symptoms might resemble a stroke but also may include headaches or seizures. An AVM that has not bled is called an un-ruptured AVM.
Reference
Mohr JP, Parides MK, Staph C et al. Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomized trial. Lancet 2014;383(9917):614-621.