New York, New York (PRWEB) November 22, 2013
Multiple sclerosis (MS) is a disease of uncertain etiology characterized by demyelinating lesions affecting the central nervous system. In 2009, Dr. Paolo Zamboni et al described an association between MS and extra cranial venous outflow restrictive lesions detected by extra cranial and intracranial venous duplex studies.
They named this venous outflow restriction chronic cerebrospinal venous insufficiency (CCSVI). In addition, they introduced an endovascular interventional treatment for CCSVI in an open-label study that included 65 MS patients with post procedure follow-up of over 18 months. Several subsequent prospective open-label, non-randomized studies investigated safety and efficacy of venous angioplasty in MS. Findings from these studies have generated considerable controversy but remain unproven.
Since 2009, over 30,000 MS patients worldwide have undergone an endovascular procedure. The vast majority of these procedures were done outside a clinical trial raising skepticism.
Dr. Robert Zivadinov, Professor of Neurology, Department of Neurology State University of New York at Buffalo (Buffalo, NY) reported, “The objective of our study, The Prospective Randomized Endovascular Therapy in MS (PREMiSe), was to investigate the safety and efficacy of percutaneous transluminal venous angioplasty (PTVA) for correcting CCSVI in MS in the setting of a prospective, double-blind, sham-controlled, randomized pilot trial.”
PREMiSe is believed to be the first prospective randomized double-blinded, controlled study of balloon angioplasty for MS 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,” explained Zivadinov.
The trial enrolled 30 MS patients. Phase 1 was a safety trial, involving 10 MS patients and Phase II involved a total of 20 MS patients, who were randomized to receive treatment or placebo. Researchers found no difference in clinical symptoms, brain lesions as determined on MRIs or quality of life outcomes between MS patients who underwent balloon angioplasty to correct CCSVI and those who did not receive the treatment.
Zivadinov said, “Based on our findings, our 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.
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