Venous Angioplasty Lacks Efficacy in Multiple Sclerosis

Siddiqui et al report in Neurology the results of a trial regarding the safety and efficacy of venous angioplasty in patients with multiple sclerosis (MS) and extracranial venous anomalies, causing Chronic Cerebrospinal Venous Insufficiency (CCSVI).

The Prospective Randomized Endovascular Therapy in MS (PREMiSe) study included 19 patients with MS and extracranial venous anomalies causing CCSVI.  Nine patients were randomly allocated to undergo balloon angioplasty and 10 to sham angioplasty.  All study patients fulfilled the Zamboni Doppler flow criteria for CCSVI. Assessment was at 1, 3, and 6 months post-procedure with MRI, clinical, and hemodynamic outcomes. Primary endpoints were safety at 24 hours and 1 month, venous outflow restoration >75% at 1 month, and effect of angioplasty on new lesion activity and relapse rate over 6 months. Secondary endpoints included changes in disability, brain volume, cognitive tests, and quality of life.

No perioperative complications were noted; however, one patient with history of syncope was diagnosed with episodic bradycardia requiring placement of a pacemaker before discharge. Doppler evidence-based venous hemodynamic insufficiency severity score (VHISS) was reduced >75% compared to baseline in phase 1 (at 1 month) but not phase 2. In phase 2, higher MRI activity (cumulative number of new contrast-enhancing lesions [19 vs 3, p = 0.062] and new T2 lesions [17 vs 3, p = 0.066]) and relapse activity (4 vs 1, p = 0.389) were identified as non-significant trends in the treated vs sham arm over 6 months. Using analysis of covariance, significant cumulative new T2 lesions were related to larger VHISS decrease (p = 0.028) and angioplasty (p = 0.01) over the follow-up. No differences in other endpoints were detected.

The authors concluded that clinical and imaging outcomes are no better or worse in patients with MS and venous outflow restriction who were treated with venous angioplasty compared to sham controls who did not receive angioplasty, therefore venous angioplasty is not an effective treatment for MS over the short term and may exacerbate underlying disease activity.