Abstract

The management of cerebral arteriovenous malformations requires balancing the risk of treatment against the natural history of the lesion left untreated. A properly designed randomised trial would, therefore, be very instructive. Unfortunately, the ARUBA study1Mohr 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: 614-621Summary Full Text Full Text PDF PubMed Scopus (771) Google Scholar is poorly designed, in large part, because it treats all unruptured arteriovenous malformations the same when in fact they represent a heterogeneous disease. Size, location, age, anatomy of venous drainage, associated aneurysms, eloquence of involved cortex, and other factors have a large and well-documented role in determining substantial differences in the risk of both rupture and treatment. To make matters worse, the investigators lump microsurgery, embolisation, stereotactic radiosurgery, and combinations of these treatments into a category called interventional therapy, as if these treatments were equivalent in terms of their risks, benefits, and indications. Nothing could be further from the truth. Finally, the stroke endpoint is not a validated outcome measure. A more meaningful endpoint would be modified Rankin score at 10 years, at least for those treated with surgery with or without embolisation. For radiosurgery, a much longer time would be needed to gauge effectiveness, and for embolisation alone, we would need further data about the final angiographic result. The exercise, however, becomes futile when taking into account arteriovenous malformation-specific and patient-specific factors, because the study is fatally underpowered. In summary, the data reported in this Article,1Mohr 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: 614-621Summary Full Text Full Text PDF PubMed Scopus (771) Google Scholar while sure to be widely quoted, will do little, regardless of additional follow-up, to meaningfully direct the care of patients with unruptured arteriovenous malformations. We declare that we have no competing interests. Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trialThe 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. The trial is continuing its observational phase to establish whether the disparities will persist over an additional 5 years of follow-up. Full-Text PDF Management of brain arteriovenous malformations – Authors' replyARUBA1 is the first-ever randomised controlled trial comparing clinical outcome in patients with unruptured brain arteriovenous malformations managed either with or without preventive interventional therapy. The as-treated analysis showed a more than 5-fold increased risk of primary outcome events (ie, death or symptomatic stroke) for patients undergoing invasive therapy (hazard ratio 5·26, 95% CI 2·63–11·11), as well as a significantly increased risk of, at times, devastating neurological deficits after intervention (relative risk 2·77, 95% CI 1·20–6·25). Full-Text PDF

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