Published March 27, 2013
Balloon angioplasty does not improve outcomes for patients with multiple sclerosis—and, in a few cases, worsened symptoms, according to a landmark UB clinical trial.
While the intervention is safe and not associated with serious adverse events, it did not provide sustained improvement in MS patients.
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 chronic cerebrospinal venous insufficiency (CCSVI) and those who did not.
“It was quite the opposite of what we originally expected to find. The study showed that endovascular treatment of stenosed veins had no effect in MS patients.”
UB’s is believed to be the first prospective, randomized, double-blind, controlled study of balloon angioplasty for CCSVI performed with Institutional Review Board approval in the U.S.
Since 2009, approximately 30,000 MS patients worldwide have undergone interventional endovascular therapy; the vast majority of them were not in clinical trials.
“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 consider enrolling in trials rather than undergoing these procedures on a fee-for-service basis,” Siddiqui says.
The intervention, sometimes called “Liberation Therapy,” has attracted intense interest in the MS community. It is based on the hypothesis that narrowing in the large veins in the neck and chest could cause improper drainage of blood from the brain, resulting in eventual injury to brain tissue.
It was thought that angioplasty, commonly used to treat atherosclerosis, might remedy the blockages.
The UB researchers stress that their trial was small and that larger, similarly rigorous studies should be undertaken.
“This is not the last word on this endovascular treatment for MS,” Siddiqui says. “However, these findings lead us to caution strongly against the general acceptance of this invasive procedure for MS patients.”
Researchers studied 30 MS patients, most from Western New York.
Ten were involved in the first phase, a safety trial; 20 were randomized to receive treatment or placebo during the second.
The study, known as the Prospective Randomized Endovascular Therapy in MS Trial—PREMISe, for short—took shape as a collaboration between the departments of neurosurgery and neurology at the suggestion of L. Nelson Hopkins, MD, SUNY Distinguished Professor and chair of neurosurgery, who is co-principal investigator.
Researchers at the UB School of Medicine and Biomedical Sciences were “uniquely situated” to study this important question, Siddiqui points out.
“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,” he says.
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,” says Robert Zivadinov, MD, PhD, professor of neurology, BNAC director and co-principal investigator on the PREMISe trial.
Researchers presented their findings March 20 in an “Emerging Science” poster session at the annual meeting of the American Academy of Neurology.
In addition to Siddiqui, Zivadinov and Hopkins, the following UB professors contributed significantly to the study:
Other UB co-investigators are Yuval Karmon, Jihnhee Yu, Karen Marr, Vesela Valnarov, Murali Ramanathan, Deepa P. Ramasmamy, Kresimir Dolic, David Hojnacki, Ellen Carl and Cheryl Kennedy.