medwireNews: The prematurely halted ARUBA study shows that intervention in patients with unruptured brain ateriovenous malformations (AVMs) may do more harm than good.
Over 3 years of follow up, the primary outcome of stroke or death occurred in significantly more patients in the intervention group than the medical management group, reported Jay Mohr (Columbia University, New York, USA) at the European Stroke Conference in London, UK.
He stressed that the Data and Safety Monitoring Board had had concerns for some time before ending the randomized phase for efficacy, but had allowed the trial to continue to be sure they were not terminating it too early.
At the time the trial was halted, 223 patients had been recruited, randomly assigned to receive intervention or medical management, and followed up for about 3 years, on average. There were six crossovers to the intervention arm, because of patients insisting on intervention. Indeed, many potential US study centers were unable to participate because of patients refusing medical management, said Mohr.
Three patients in the intervention arm had a stroke before receiving any intervention, so were counted as medical management, and 20 assigned to intervention were yet to receive treatment when ARUBA was halted.
When analyzed according to their randomized treatment, the rates of stroke or death were 10.1% in the medical management arm versus 29.0% in the intervention arm, equating to a significant 65% risk reduction. The results were similar when patients were analyzed according to the treatment actually received, with 7.9% versus 35.1% meeting the primary outcome, giving a 77% reduction.
This was reflected in patients' functional outcomes, with 6.9% versus 22.6% of patients in the medical versus interventional treatment arms having a modified Rankin Scale (mRS) score of 2-6.
Mohr cautioned that the trial was unable to assess specific treatment modalities, which were determined by the treating physicians, so it is not known whether one particular intervention was responsible for the increased stroke and death rate in the intervention arm.
The percentage of patients in the intervention arm with an mRS of 2-6 remained above that in the control group throughout follow up. However, Mohr noted that these relatively young patients (average age 44 years) could potentially improve over time, thus erasing the difference between the two groups.
He said that "this is a possibility for us to observe in the future, and a very important point of our planned follow up," for which they are seeking funding.
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The ARUBA trial