National Institute of Neurological Disorders and Stroke (NINDS) Stops Enrolling Patients in ARUBA Study Earlier than Planned
Mount Sinai’s International Center for Health Outcomes and Innovation Research (InCHOIR) is the data-coordinating center for the trial
Today the National Institute of Neurological Disorders and Stroke (NINDS) announced that "A Randomized Trial of Unruptured Brain Arteriovenous Malformations" (ARUBA) has stopped enrolling patients because of higher than expected event rates in the interventional therapy arm.
The International Center for Health Outcomes and Innovation Research (InCHOIR) at the Icahn School of Medicine at Mount Sinai is the international data-coordinating center for the trial. "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," said Alan J. Moskowitz, MD, Professor and Vice Chair of Health Evidence and Policy at the Icahn School of Medicine, and Co-Director of InCHOIR). "It is our recommendation that extended follow-up is needed to determine whether these disparities in rates will persist over time."
The data, analyzed by InCHOIR under the direction of Michael Parides, PhD, Director of the Center for Biostatistics at the Icahn School of Medicine at Mount Sinai, has shown that after a mean follow-up of 33 months, the event rate in the intervention group was more than three times higher than in the medical management group. The analysis included data from 224 participants enrolled in the study’s 39 worldwide sites, in an effort that was coordinated by Ellen Moquete, RN, BSN, Director of Trials Operations at InCHOIR. Originally the study planned to enroll 400 participants, however, because of the higher than expected event rate in the interventional therapy arm, the ARUBA Data and Safety Monitoring Board has recommended stopping enrollment while continuing to follow those in the study to see if the difference changes over time.
Another key endpoint in the trial is functional status, said Dr. Parides. "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."
ARUBA is a randomized, multi-center trial designed to evaluate whether symptomatic medical management improves long-term outcomes of patients with unruptured brain arteriovenous malformations compared to invasive treatment for the composite event of death from any cause or symptomatic stroke. There will be a detailed analysis of the data as well as further results presented at the European Stroke Conference in London on May 31.
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The Mount Sinai Hospital, founded in 1852, is a 1,171-bed tertiary- and quaternary-care teaching facility and one of the nation’s oldest, largest and most-respected voluntary hospitals. In 2011, U.S. News & World Report ranked The Mount Sinai Hospital 16th on its elite Honor Roll of the nation’s top hospitals based on reputation, safety, and other patient-care factors. Of the top 20 hospitals in the United States, Mount Sinai is one of 12 integrated academic medical centers whose medical school ranks among the top 20 in NIH funding and U.S. News & World Report and whose hospital is on the U.S. News & World Report Honor Roll. Nearly 60,000 people were treated at Mount Sinai as inpatients last year, and approximately 560,000 outpatient visits took place.