August 12, 2011 at 1:22pm
An important message from Dr. Zamboni regarding the newly published study placed online today. This is the 2nd CCSVI endovascular treatment study undertaken in Ferrara, Italy. The patients were Italian and American, in cooperation with BNAC. There were two groups, an immediate treatment group, and a delayed treatment group, The MRI technicians were blinded as to who was in which group. All patients were on disease modifying drugs before, during and after, for consistancy in treatment. This is very important to understand. Angioplasty for CCSVI reduced lesions, improved MS symtoms and reduced relapses, when compared to those in the delayed group on the drugs alone. Here's the note from Dr. Zamboni-
Here attached for you, from the site of the European Journal of Vascular Endovascular Surgery, the second treatment study. This study is also known as MS-EVT treatment of American and Italian patients who have traveled from across the Atlantic to be treated.
The study design is unique in the history of medicine. The patients were operated on in Ferrara, but the results were audited in Buffalo. Patients were divided into two mixed groups of Italians and Americans. The first ITG (immediate treatment group) was operated on immediately, while the second group DTG (delayed treatment group) was treated six months later, allowing us to compare the ITG with DTG. Finally, we compared patients in the second six months, when both groups were operated on. Then, all patients were compared with their original state during the previous year, prior to PTA.
The study is small (we had no money to do more), however, is very strong, certainly stronger than that of 2009 JVS, as it eliminates many of the criticisms of the latter. Particularly--
1. There is a control group for comparison, in practice it as a randomized as possible for use in surgery
2. MRI measures are rigorous, high-standard 3-tesla, comparable and indisputable as completely blind
3. Patients were evaluated by neurologists and neuroradiologists of two centers
4. Statistical analysis was done by an independent statisticians and blinded.
What does it prove
1. Both groups after the PTA had a significant improvement in the MSFC score compared to previous year, with substantial maintenance of EDSS (no disease progression)
2. In the ITG during the first 6 months there were fewer relapses. The percentage has been on an annual basis of 0.16 against 0.66 of the DTG. In fact the DTG in the first six months received only drugs. After surgery, the DTG no longer had more relapses than the ITG, confirming the protective effect of PTA on relapses.
3. ITG T2 lesion load decreased while the DTG increased. After the PTA in the DTG lesion load stabilized during the second six months.
4. Complications were zero, zero thrombosis
5. 27% restenosis
6. ITG had one patient- despite the PTA, who had a recurrence and worsening on the MRI, confirming that the MS-CCSVI can not be handled alone by only interventionist. This article suggests the causes of deterioration after PTA on which new studies are needed.
1. Ahead Zivadinov and all 17 consecutive patients had venography confirmed CCSVI
2. the ITG had an effect more pronounced in brain volume reduction than that of the DTG, a likely anti-edema and anti-inflammatory effect of the PTA.
* CCSVI is associated with MS --as the first treatment of the condition changes the clinical parameters of the second
* The modification of parameters in a blinded MRI is totally immune from the placebo effect, then measured the improvements are real
* The treatment is safe in safe hands and can be beneficial
* To say after these two pilot studies, positive treatment studies, epidemiological studies have to wait is not sustainable
Paolo Zamboni, MD
Director, Vascular Diseases Center
University of Ferrara
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