One of the symptoms that characterize chronic cerebrospinal venous insufficiency (CCSVI) is the venous outflow from the brain and spinal cord. But whether this condition is associated with multiple sclerosis (MS) and whether venous percutaneous transluminal angioplasty (PTA) is beneficial for MS is unclear. The objective of this study is to determine the efficiency and safety of venous PTA in patients with MS and CCSVI.
This is a randomized, double-blind, sham-controlled, parallel-group trial that consisted of 177 patients with relapsing-remitting MS. 62 of them were ineligible, including 47 who did not have CCSVI. The eligible patients were randomly allocated either venous PTA or catheter venography (sham) in a 2:1 proportion. The primary outcomes of the study were to assess a composite functional measure and a measure of new combined brain lesions.
The researchers found that out of 76 patients who were allocated venous PTA, 38 achieved flow restoration. There was no difference in functional composite measures between the PTA and sham groups. At follow-up after 6-12 months, 58 patients of the PTA group (83%) and 22 of the sham group (67%) were free of new lesions.
The research concluded that venous PTA was a safe but largely ineffective technique that could not be recommended to patients with MS.