Endovascular Treatment Results
At this meeting, Dr. Zamboni and Dr. Zivadinov and colleagues presented results of a small pilot safety trial of endovascular treatment of venous lesions in patients with MS. A first small pilot study was published in December 2009 and reported by Medscape Medical News at that time (J Vasc Surg. 2009;50:1348-1358).
In the current trial, called the EVTMS study, 15 patients with relapsing-remitting MS and evidence of CCSVI were enrolled and randomized to receive either immediate endovascular treatment (8 patients) or treatment delayed for 6 months (7 patients), and these were compared with 8 healthy controls.
Treatment of significant stenosis was with angioplasty alone, and patients were prospectively followed up at 3, 6, 9, and 12 months with sonography, MRI (at 6 and 12 months), and clinical examination.
No serious adverse events were seen, with the exception of 1 transitory vasovagal syndrome 1 hour after the intervention, they report.
"No significant clinical or MRI differences have been seen, although there were less relapses in the immediate treatment group, 1 vs 4, and a decrease in T2 lesion volume in the immediate group, about 10%," Dr. Zivadinov noted. Restenosis did not occur in any of the azygous veins treated but was seen in 29% in the internal jugular veins.
"I think based on this study that we can't say more than there is no deterioration of the patients who are getting this type of treatment, and we need to do more specific placebo-controlled trials to understand whether this treatment is useful or not, but I would add that no remarkable differences have been seen in this first study," he said.