Abstract
We have a lot to learn and improve in arterovenous malformation (AVM) management, and one good approach to testing relevant hypotheses is the randomised trial. It is, however, crucial that (1) the hypotheses are relevant, (2) there are robust inclusion and exclusion criteria, (3) the study population is correctly identified and (4) the endpoints are relevant. ARUBA (a randomised trial of unruptured brain arterovenous malformations) aims to test the following hypothesis: “The group consisting of any interventional treatment of any potentially treatable unruptured AVM fares worse than a similar group treated noninterventionally during a five-year follow-up”. In other words, the aim of ARUBA is to test whether interventional treatment as such is worse than no intervention; there is no stratification between surgery, radiosurgery, interventional neuroradiology or any combination thereof. The primary outcome parameter is death or stroke from any cause within a 5-year period.
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