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Randomized Controlled Trial
. 2012 Jan;43(1):116-22.
doi: 10.1016/j.ejvs.2011.03.035. Epub 2011 Aug 11.

Venous Angioplasty in Patients With Multiple Sclerosis: Results of a Pilot Study

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Randomized Controlled Trial

Venous Angioplasty in Patients With Multiple Sclerosis: Results of a Pilot Study

P Zamboni et al. Eur J Vasc Endovasc Surg. .
Free article

Abstract

Objectives: Chronic cerebrospinal venous insufficiency (CCSVI) is associated with multiple sclerosis (MS). The objective of the study was to see if percutaneous transluminal angioplasty (PTA) of duplex-detected lesions, 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: We studied 15 patients with relapsing-remitting MS and duplex-detected CCSVI.

Methods: Eight patients had PTA in addition to medical therapy (immediate treatment group (ITG)), whereas seven had treatment with PTA after 6 months of medical therapy alone (delayed treatment group (DTG)).

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 (p < 0.02). The annualised relapse rate was 0.12% in the ITG compared with 0.66% in the DTG (p = NS). Magnetic resonance imaging (MRI) blindly demonstrates a trend for fewer T2 lesions in the ITG (p = 0.081), corresponding to a 10% decrease in the ITG compared with a 23% increase in the DTG over the first 6 months of the study.

Conclusions: This study further 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.

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