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Results from a prospective, randomized, sham-controlled, double-blind clinical trial of venous angioplasty in individuals with MS who display signs of CCSVI

Background:

A significant amount of research has been done to better understand the relationship between chronic cerebrospinal venous insufficiency (CCSVI) and MS. Research is still underway in order to provide answers for people living with or affected by MS.

Dr. Adnan Siddiqui and colleagues in Buffalo conducted the first prospective, double-blind, sham-controlled, randomized clinical trial to test a procedure commonly known as “liberation therapy” in people with MS. Liberation therapy involves a procedure called venous angioplasty, in which a balloon is inserted in veins to improve blood flow. The results from the trial, called Prospective Randomized Endovascular Therapy in MS (PREMiSE), were recently published in Neurology.

The Study:

The researchers conducted a 2-phase study to investigate the safety and efficacy of enous angioplasty in individuals with MS who exhibited venous outflow abnormalities characteristic of CCSVI. The participants were enrolled between June 010 and March 2012. In order to be included in the trial, they had to fulfill two or more of the criteria for CCSVI. Due to the fact that it was a pilot study, the total sample size was restricted.

Phase 1 of the trial was conducted in 10 people with MS to evaluate the safety of venous angioplasty and strengthen procedural protocols. Phase 2 of the trial included 19 participants with MS, of which10 received a sham procedure as a comparator, and 9 underwent venous angioplasty. Magnetic resonance imaging (MRI) scans were done at 1, 3 and 6 months post-procedure, and researchers looked for significant changes in venous outflow, lesion activity on MRI and relapse rate. Additional assessment included evaluating changes in disability, brain volume, cognition, and quality of life.

Results:

Results from phase 1 indicated that venous angioplasty was well tolerated, and can be performed safely in human participants. In phase 2, one person in the treated group experienced a reduction in heart rate, resulting in the insertion of a pacemaker. The researchers noted that although this condition appeared to have preexisted
in the individual, the event could be possibly related to venous angioplasty.

Efficacy data collected from phase 2 revealed that in the treatment group, four relapses occurred among three people, compared to one relapse in the sham group. It was also found that five participants of the 9 who received venous angioplasty had MRI findings indicative of disease activity.

There were no significant differences noted in disability, brain volume, cognition, and quality of life measures between the two groups in phase 2.

Comment:

The researchers concluded that venous angioplasty is not an effective treatment for MS over a short period of time and may in fact contribute to increasing disease activity. This increased disease activity was witnessed in treated individuals by MRI and relapses.

They noted that the study findings were limited by a small sample size. However, the results contribute to a growing body of evidence that does not support the benefits of venous angioplasty, and challenge the notion that CCSVI is a causative factor, in MS.

The MS Society recognizes the importance of supporting research into all potential treatments, and understands that people with MS seek definitive answers about CCSVI. The organization continues to support a Canadian CCSVI trial led by Dr. Anthony Traboulsee from the University of British Columbia Hospital MS Clinic. The trial is in the recruitment stage, and the MS Society will continue to provide updates as they become available.

Source:

Siddiqui AH et al. Prospective randomized trial of venous angioplasty in MS (PREMiSe). Neurology 2014 July 29; 83(5): 441-449.