"The whole idea of PREMiSe was to find out if opening up the veins that drain blood from the brain and the spinal cord would improve outcomes for MS patients," said Bianca Weinstock-Guttman, MD, UB professor of neurology and director of UB's MS Center.
"What we found was rather surprising and unexpected," Siddiqui said. "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."
A total of 30 MS patients, most of whom were from Western New York, were studied in the PREMiSe trial. 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.
The UB 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.
The researchers stressed that the UB study was small and that larger studies should be undertaken and should be conducted in a rigorous fashion with IRB approval, as was PREMiSe.
"This is not the last word on this endovascular treatment for MS," Siddiqui concluded. "This is the first word because this was the first double-blinded, randomized sham-controlled trial on the subject. However, these findings lead us to caution strongly against the general acceptance of this invasive procedure for MS patients."
|Contact: Ellen Goldbaum|
University at Buffalo