Procedure is safe but does not improve MS outcomes, a finding that the UB investigators call 'surprising and unexpected'
The first controlled clinical trial to test the safety and efficacy of interventional endovascular therapy on the symptoms and progression of multiple sclerosis has found that the intervention, sometimes called the "liberation treatment," which has attracted intense interest in the global MS community, does not improve patient outcomes. In a few cases, the treatment made symptoms worse.
University at Buffalo researchers will present their results in an "Emerging Science" poster session March 20 at the annual American Academy of Neurology meeting in San Diego. They discuss the findings in this video (http://youtu.be/94gLM4QlU_A).
The Prospective Randomized Endovascular Therapy in MS (PREMiSe) trial is believed to be the first prospective randomized double-blinded, controlled study of balloon angioplasty for MS being performed with Institutional Review Board approval in a rigorous fashion in the U.S. with significant safeguards in place to ensure careful determination of risks and benefits. All screening, diagnostic, interventional and follow-up procedures and visits were performed at no cost to the patients.
The study's key findings are that while the treatment is safe and was not associated with serious adverse events, it did not provide sustained improvement in MS patients.
Based on their findings, the UB researchers' primary message to MS patients and their doctors is that endovascular treatment for chronic cerebrospinal venous insufficiency (CCSVI) should only be done in the context of randomized, double-blinded, controlled studies like PREMiSe.
"Our strong recommendation to patients and to practitioners, who have, in earnest, been seeking betterment for their disease and a cure for MS is that they should instead consider enrolling in trials, rather than undergoing these procedures on a fee-for-service basis," said Adnan Siddiqui, MD, assistant professor of neurosurgery, UB School of Medicine and Biomedical Sciences and PREMiSe principal investigator.
Since 2009, approximately 30,000 MS patients worldwide have undergone the endovascular procedure that opens blockages in veins that drain blood from the brain. The vast majority of these procedures were done on a fee-for-service basis, and not as part of clinical trials.
The idea for PREMiSe took shape as a collaboration between the UB Department of Neurosurgery and the UB Department of Neurology at the suggestion of L. Nelson Hopkins, MD, SUNY Distinguished Professor and chair of neurosurgery, who is co-principal investigator.
The researchers at the UB School of Medicine and Biomedical Sciences were "uniquely situated" to study this important question, Siddiqui said. "Here at UB, some of the world's leaders in stroke intervention, in the Department of Neurosurgery, are located right next door to some of the world leaders in multiple sclerosis in the UB Department of Neurology and in imaging at the Buffalo Neuroimaging Analysis Center (BNAC)," he said.
Researchers at UB's BNAC have published or presented more than 25 studies on CCSVI and its relationship to neurological diseases including MS.
"Our findings over the last three years have indicated that CCSVI is more prevalent in MS patients than in healthy controls but the cause or consequence of these venous abnormalities has not been established," said Robert Zivadinov, MD, PhD, FAAN, UB professor of neurology, director of the BNAC and co-principal investigator on the study.