Epub ahead of print
: Zamboni et al. Venous Angioplasty in Patients with Multiple Sclerosis: Results of a Pilot Study. European Journal of Vascular & Endovascular Surgery. published online 12 August 2011.
: The objective of the study was to see if percutaneous transluminal angioplasty (PTA) of of the internal jugular and/or azygous veins, was safe, burdened by a significant restenosis rate, and whether there was any evidence that treatment reduced MS disease activity.
Design: This was a case-control study.
Materials: The investigators studied 15 MS’ers with RRMS and CCSVI.
Methods: 8 MS’ers had PTA in addition to medical therapy (immediate treatment group), whereas 7 had treatment with PTA after 6 months of medical therapy alone (delayed treatment group).
Results: No adverse events occurred. At 1 year, there was a restenosis rate of 27%. Overall, PTA was followed by a significant improvement in functional score compared with baseline. The annualised relapse rate was 0.12 in the immediate treatment group compared with 0.66 in the delayed treatment group (not significantly different). MRI demonstrates a trend for fewer T2 lesions in the immediate treatment group compared with the delayed treatment group over the first 6 months of the study.
Conclusions: This study confirms the safety of PTA treatment in patients with CCSVI associated with MS. The results, despite the significant rate of restenosis, are encouraging and warrant a larger multicentre double-blinded, randomised study.
“This study is under powered for both efficacy and adverse events. There are simply too few MS’ers treated to draw any conclusions over the effectiveness or safety of angioplasty.”
“A better study design would have been a randomised double-blinded control trial of sham angioplasty vs. actual angioplasty for CCSVI (please see previous posts on this topic). Powering such a study would be very difficult given the very low reported incidence, from recent studies, of CCSVI in MS’ers.”