There has been longstanding uncertainty of whether medical management alone or additional interventional therapy is better for patients with a brain arteriovenous malformation that has never bled. Reports of case series and comparative observational studies showed variable risks of clinical outcomes and angiographic obliteration. The investigators of A Randomized trial of Unruptured Brain Arteriovenous malformations (ARUBA) tried to address this knowledge gap by comparing if one treatment strategy was superior for preventing death or stroke. However, patient recruitment was halted prematurely when the investigators saw that after a mean follow-up of 33.3 months, medical management was significantly superior to interventional therapy (HR:0.27, 95% CI: 0.14–0.54).
The aim of the present study was to conduct a long-term analysis of the initial ARUBA trial, determining the clinical differences of medical management or interventional therapy in patients with a brain arteriovenous malformation, including patients enrolled until the official termination of recruitment.
ARUBA was a non-blinded, randomised, multicentre trial that included adult patients with an unruptured brain arteriovenous malformation who had not received interventional therapy previously but were suitable for intervention to eradicate the lesion. 226 eligible patients were randomised to receive either medical management alone (n=110) or in combination with interventional therapy (n=116), including neurosurgery, embolisation, and stereotactic radiotherapy as single or multiple therapies. The primary study outcome was time to death or symptomatic stroke determined by imaging techniques.
In line with previous findings, after a mean follow-up time of 50.4 month, investigators found a significantly lower incidence of death or symptomatic stroke with medical management compared to the group that received additional interventional therapy (HR:0.31, 95% CI: 0.17–0.56; Figure 1). Additionally, patients without intervention had a significantly lower risk of neurological disability and adverse events were seen less frequently in those patients.
The study showed that in patients with unruptured brain arteriovenous malformations, death or symptomatic stroke can be more efficiently prevented by medical management compared to interventional therapy approaches. The strong difference between the two groups, which even led to the termination of recruitment, calls for a change in specialist practices and adapted patient information strategies. The authors state that long-term risks beyond the studied follow-up time should be subject to further investigation.
The long-term results of the ARUBA study confirmed a significant superiority of medical management compared to interventional therapy approaches in patients with an unruptured brain arteriovenous malformation.
For the full publication: Mohr JP et al. Lancet Neurol. 2020; 19:573–81.