Lancet Neurology: Comparison of unrecrupted cerebrovascular malformation (ARUBA) drug interventional therapy with simple drug therapy: final follow-up in a multi-center, non-blind, randomized controlled trial

In a randomized trial of unrecrupted cerebral venous malformations (ARUBA), a pre-specified interim analysis showed that simple drug therapy was superior to drug therapy and interventional therapy in preventing symptomatic stroke or death, and that randomized trials were stopped during an average of 33.3 months of follow-up.
the purpose of this paper is to study whether these differences persist during the five-year follow-up.
: ARUBA is a non-blind randomized trial conducted at 39 clinical centres in 9 countries.
its inclusion criteria are: adults (age ≥18 years old) are diagnosed with unresolven brain vein malformations, have never received interventional treatment, and are considered suitable for intervention by participating clinical centres to eradicate lesions.
Patients are randomly assigned (1:1) by a web-based data collection system, layered by clinical centers in randomly arranged blocks of sizes 2, 4 and 6, for drug therapy or joint interventional therapy (individually or in any combination, order or quantity for neurosurgery, embolism, or stereotactic radiation therapy).
patients and researchers at one center were not kept secret from treatment, researchers at other centers were not informed of any of the center's tasks or results.
the main results are imaging-confirmed times of death or symptomatic strokes, assessed by neurologists at each centre that does not participate in participant care management, and monitored by an independent committee using adaptive methods and mid-term analysis.
the study began on 4 April 2007 and ceased on 15 April 2013 and continued until 15 July 2015.
results: Of the 1,740 patients screened, 226 were randomly assigned to receive drug therapy alone (n-110) or drug-combined interventional therapy (n-116).
in follow-up at an average of 50.4 months (standard deviation 22.9), the rate of death or symptomatic stroke treated with mere medication (15 out of 110 cases, 3.39 per 100 patients per year) case) lower than the interventional treatment group (41 out of 116 cases, 12.32 per 100 patients per year; risk ratio 0.31,95% confidence interval 0.17 to 0.56).
2 cases in the drug treatment group and 4 cases in the interventional treatment group (2 cases attributable to interventional therapy) died in follow-up.
the rate of adverse events in patients receiving medication was lower than in interventional treatment (283 vs. 369; 58.97 vs 78.73 per 100 patient years; risk differences -19.76, 95% CI-30.33-9.19).
summary, after an average of 50 months of follow-up, in the ARUBA trial, individual drug therapy was still better than drug-combined interventional therapy for the prevention of death or symptomatic stroke in patients with unresolbed cerebral vein malformations.
Mohr, Jay P et al. Medical management with interventional therapy versus medical management alone for unruptured brain arteriovenous malformations (ARUBA): final follow-up of a multicentre, non-blinded, randomised controlled trial. The Lancet Neurology, Volume 19, Issue 7, 573 - 581 MedSci Original Source: MedSci Original Copyright Notice: All text, images and audio and video materials on this website that state "Source: Met Medical" or "Source: MedSci Original" are owned by Mets Medical and are not authorized to reproduce by any media, website or individual.
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