The National Institute of Neurological Disorders and Stroke (NINDS) has halted enrolment in a randomized trial comparing intervention vs medical management in patients with unruptured arteriovenous malformations (AVMs) due to higher than expected event rates in the interventional group.
The news was announced in statements today from NINDS, and from the International for Health Outcomes and Innovation Research (InCHOIR) at the Icahn School of Medicine at Mount Sinai, New York, New York, the international data-coordinating center for the trial.
The trial, dubbed A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA), is a randomized, double-blind, multicenter trial with the aim of comparing long-term outcomes of symptomatic medical management vs invasive treatment using interventional procedures, neurosurgery, or radiation therapy for the composite endpoint of death from any cause or symptomatic stroke.
"Upon the recommendation of the ARUBA Data and Safety Monitoring Board, the NINDS has stopped enrollment of patient volunteers into the trial," the NINDS statement notes. "Under the experimental conditions in this trial, the interim analysis of data collected to date shows that medical management is superior to intervention in patients with unruptured brain arteriovenous malformations (AVMs). The DSMB [Data Safety and Monitoring Board] further recommended extended follow-up to determine whether the disparity in event rates will persist over time.
The ARUBA trial is conducted under the clinical leadership of J. P. Mohr, MD, from Columbia University, New York, New York, and Christian Stapf, MD, from Hôpital Lariboisière, Paris, France, and the data analytical and biostatistical leadership of Alan Moskowitz, MD, professor and vice-chair of Health Evidence and Policy at the Icahn School of Medicine and co-director of InCHOIR, and Michael Parides, PhD, director of the Center for Biostatistics at the Icahn School of Medicine, the NINDS statement notes. The study is supported by cooperative agreements from the NINDS.
"We have discovered that, in an interim analysis of the data collected so far, medical management was superior to interventional therapy for patients with unruptured brain arteriovenous malformations," Dr. Moskowitz said in the statement from his institution. "It is our recommendation that extended follow up is needed to determine whether these disparities in rates with persist over time."
An interim analysis at 33-month follow-up on data from 224 of the target 400 participants showed that the event rate in the intervention group was more than 3 times higher than in the medical management group, the statement notes.
Because of this higher than expected event rate, the ARUBA Data and Safety Monitoring Board recommended halting enrollment, although follow-up will continue in patients already enrolled.
Another important endpoint is functional status, Dr. Parides, said in his institution's statement. "Continued follow-up of patients will help determine whether the observed differences in event rates will translate into meaningful long-term differences in patient functioning."
The study was not powered to detect differences between the 3 interventional approaches, the NINDS statement notes.
More detailed analysis of the ARUBA results will be presented at the European Stroke Conference in London, United Kingdom, on May 31, the release notes.
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Cite this: NINDS Halts ARUBA Trial of Patients With Unruptured AVM - Medscape - May 10, 2013.