Sunday January 21st 2018

Don’t Dismiss CCVSI Yet, Expert Says

ccsviDoctors should encourage their patients with multiple sclerosis (MS) who are curious about chronic cerebrospinal venous insufficiency (CCVSI) to “hold off” getting the related procedure until results are in from what some view as a potentially definitive trial on the merits of this intervention, according to Alexander Rae-Grant, MD, neurologist and chair, Neurological Education, Cleveland Clinic, Ohio.

The multicenter trial, led by Anthony Traboulsee, MD, assistant professor, neurology, and medical director, University of British Columbia Hospital MS Clinic, Vancouver, Canada, will compare venous angioplasty with a sham procedure in patients with MS. The theory behind CCSVI is that blocked veins in the head and neck result in excessive iron in the brain and may contribute to the disease process in MS.

“Until you subject this to a well-designed, randomized trial in which it’s compared to a sham procedure, and you’re sure that you’ve excluded the possibility that there isn’t a therapeutic effect because of small sample size, you really don’t know” if it works or not, said Dr. Rae-Grant told Medscape Medical News here during an interview.

He spoke during a symposium on Controversial Unconventional Therapies at the 5th Cooperative Meeting of the Consortium of MS Centers (CMSC) and the Americas Committee for Treatment and Research in MS (ACTRIMS).

Prove Once and for All?

The Canadian trial should “prove the point once and for all” in terms of the effect of treatment, said Dr. Rae-Grant. “One way or the other, the Canadian trial will be the ultimate answer in terms of therapeutics, not in terms of whether there are vascular abnormalities, but in terms of whether this therapeutic intervention is something we should be looking to.”

So far, said Dr. Rae-Grant, there have really been only 2 treatment trials: the initial positive trial in 2009, led by Paolo Zamboni, MD, that launched the controversy surrounding the validity of the procedure, and a subsequent negative but “fairly small” trial.

The Prospective Randomized Endovascular Therapy in MS (PREMiSe) enrolled 10 patients in a phase 1 safety trial and 20 patients with active relapsing MS in a phase 2 trial, which randomly assigned patients to treatment or placebo. According to the results released earlier this year at the American Academy of Neurology 65th Annual Meeting, the study looked at whether the procedure was safe or associated with adverse events at 24 hours and 1 month. The primary endpoint was venous outflow restoration at month 1, as well as MRI disease activity and relapse rate.

There were no safety issues at either time point, noted the study’s co-principal investigator, Robert Zivadinov, MD, PhD, professor, neurology, University of Buffalo, New York, but for venous outflow restoration, this endpoint was met only in phase 1. In phase 2, venous outflow did not improve with the actual or with the sham procedure.

“The main outcome of the study was very surprising to us,” Dr. Zivadinov told Medscape Medical News at that time. Of the 9 patients who underwent venoplasty, 5 had increased disease activity after intervention, with a total of 19 new gadolinium-enhancing lesions and 17 new T2 lesions, vs 3 total new lesions in the sham procedure group. There were 4 relapses in treated patients vs 1 in the sham group. Treatment groups did not differ for quality of life, with all patients reporting improvements.

“So there was a clear-cut increase of disease activity in treated people,” he said. “In people with active relapsing MS, I don’t think this treatment is appropriate and could lead to potential harm.” The researchers will be following these patients for more long-term results.

At the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), results of the COSMO trial, a case-control observational study carried out by Italian researchers, showed the incidence of CCSVI was low and did not differ between groups of patients with MS, those with other neurologic diseases, or healthy controls. Another observational study, also by Italian researchers, looking at the safety of venoplasty to correct CCSVI suggested that the procedure was not without risk, with serious adverse events occurring in about 3% of patients who elected to be treated.

At that time, Giancarlo Comi, MD, director of the Department of Neurology and Institute of Experimental Neurology at the Scientific Institute and University Vita-Salute San Raffaele in Milan, Italy, concluded that given their findings and those in the venoplasty study, further interventional studies were not needed. “I think that because there is no rationale for a trial exploring the efficacy of liberation therapy, I personally think it’s absolutely inappropriate that the government finances any type of investigation or research.”

However, Dr. Zivadinov said the low incidence of CCVSI as seen in COSMO did not agree with their own experience using a larger variety of imaging modalities, including invasive techniques. The fact that they saw an increase in disease activity argues that venoplasty for CCSVI is having an effect in the brain, even though it was a negative effect.

“I strongly believe we should have further research on CCSVI as a concept, maybe switching from the MS population to more normal populations — aging and healthy people who have this problem, and understand what it means,” he said. “It’s not unique to MS, and for sure, the endovascular treatment is not an option that should be done on a clinical basis.”

Baby With the Bathwater?

Still addressing delegates during the joint CMSC/ACTRIMS meeting, Dr. Rae-Grant emphasized the importance of not dismissing the possibility that CCSVI really does work.

Read More

4 Comments for “Don’t Dismiss CCVSI Yet, Expert Says”

  • Joanne McKinnon says:

    I have MS and I went to mexico for liberation treatment. That was when this information first came out. It did help me. I felt like my old self again.
    At the present time I am feeling awful again, my left side does not work properly. I need to go somewhere and have my vein opened up again. Joanne

  • clare richards says:

    I think this is a true catch COs i did it to myself early last year and i can now walk and drive so much better than before COs my veins were blocked up!

  • clare richards says:

    This does work if you do have m.s.!

  • charles van heusen says:

    @Joanne McKinnon. How long ago did you have the procedure done? How long did it last before the problems started to reoccur? Did you have the stents put in during the procedure?

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