A local study of the safety and efficacy of angioplasty to treat multiple sclerosis has found that the intervention, sometimes called “liberation therapy,” did not improve patient outcomes and, in a few cases, made symptoms worse.
Buffalo researchers say the trial is the first rigorous study of angioplasty for chronic cerebrospinal venous insufficiency, or CCSVI, a treatment that has gained worldwide attention since 2009 when an Italian researcher, Dr. Paolo Zamboni, found a relationship between MS and signs of abnormal blood drainage in veins.
The theory upset current thinking on MS, a disease thought to be the result of an abnormal immune system attacking the brain, nerves and spinal cord. Some doctors rushed to perform balloon angioplasty or place stents in veins to reduce MS symptoms, even though the theory remained unproven and Zamboni’s work involved few patients and was uncontrolled, meaning there was not another group studied to compare results.
University at Buffalo researchers will present their findings March 20 at the annual American Academy of Neurology meeting in San Diego.
The study’s key finding is that while the treatment is safe and was not necessarily associated with serious adverse events, it did not provide sustained improvement in MS patients.
“Simply dilating a vein with a balloon does not have any overt beneficial effect, and we found increased disease activity in MRI scans, suggesting that the procedure may actually do harm,” said Dr. Adnan Siddiqui, associate professor of neurosurgery in the UB School of Medicine and Biomedical Sciences and the principal investigator.
Currently, the National Multiple Sclerosis Society says getting a procedure for CCSVI is a personal decision that MS patients should make in consultation with their doctors. Based on their findings, the UB researchers said angioplasty should only be offered to MS patients for CCSVI in the context of a randomized, controlled study, the gold standard in research.
“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 Siddiqui.
Since 2009, approximately 30,000 MS patients worldwide have undergone the endovascular procedure that opens blockages in veins that drain blood from the brain, most of them not in trials, according to the researchers.
One of the limitations of the study is its small size. Only 30 MS patients, most of them from Western New York, were studied in what the researchers described as a pilot study.
“This is not the last word on this endovascular treatment for MS,” Siddiqui said.
“We need a larger study to confirm that the results are not related to the sample size in our trial.”
The study was funded by Kaleida Health, UB, the Direct MS Foundation of Canada, Volcano Corp., ev3 Corp. and individual donors.
Dr. Timothy Coetzee, chief research officer at the National Multiple Sclerosis Society, said there have been conflicting results reported on the prevalence of CCSVI in MS, and the emergence of reports of CCSVI in people who do not have MS.