Venous angioplasty in MS: results of a pilot study

V
Epub ahead of print: Zamboni et al. Venous Angioplasty in Patients with Multiple Sclerosis: Results of a Pilot Study. European Journal of Vascular & Endovascular Surgery. published online 12 August 2011.

Study objective: The objective of the study was to see if percutaneous transluminal angioplasty (PTA) of 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: The investigators studied 15 MS’ers with RRMS and CCSVI.
Methods: 8 MS’ers had PTA in addition to medical therapy (immediate treatment group), whereas 7 had treatment with PTA after 6 months of medical therapy alone (delayed treatment group).

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. The annualised relapse rate was 0.12 in the immediate treatment group compared with 0.66 in the delayed treatment group (not significantly different). MRI demonstrates a trend for fewer T2 lesions in the immediate treatment group compared with the delayed treatment group over the first 6 months of the study.
Conclusions:  This study 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.
“This study is under powered for both efficacy and adverse events. There are simply too few MS’ers treated to draw any conclusions over the effectiveness or safety of angioplasty.” 

“A better study design would have been a randomised double-blinded control trial of sham angioplasty vs. actual angioplasty for CCSVI (please see previous posts on this topic). Powering such a study would be very difficult given the very low reported incidence, from recent studies, of CCSVI in MS’ers.”

About the author

Prof G

Professor of Neurology, Barts & The London. MS & Preventive Neurology thinker, blogger, runner, vegetable gardener, husband, father, cook and wine & food lover.

9 comments

  • Thanks for sharing 😉

    Your comment about requiring a double-blinded trial is in their conclusion:

    "The results, despite the significant rate of restenosis, are encouraging and warrant a larger multicentre double-blinded, randomised study."

    You've got to start somewhere and the team doing the trial have said they would have liked to have a larger group but funding didn't permit.

    The study negative CCSVI study you posted yesterday was only of 18 MS'ers (although you chose not to mention this in your write up), and that seems fine for negative studies. There simply is no constancy in your position, other than CCSVI phobia.

    As for your other point:

    “Powering such a study would be very difficult given the very low reported incidence, from recent studies, of CCSVI in MS'ers."

    This is just delusional I think, but time will tell. Drinks are on me if you’re right.

  • Re: "18 MS'ers" is large enough for a causation study (the factor needs to be be present in virtually 100% of MS'ers) but not enough for a treatment trial (not everybody would be expected to respond and for adverse events you need large numbers).

  • Re "CCSVI phobia"

    Not phobia, simply concerned about MS'ers being exposed to unnecessary risks, being exploited (they should not be charged for an unproven therapy) and the problem of "false hopes". Unfortunately, the science simply does not stack-up; please see my post on Bradford-Hill's criteria for causation and read the book "Bad Science".

  • Hi Professor,

    You may have answered this before, but it would be great if you could show how Vitamin D deficiency and the EVB theory fit into Bradford-Hill nine criteria for causation. Thanks.

  • Do you really think there is a single cause of MS that would show in almost 100% of MS'ers? I've often heard MS being described as 'multi-factorial'. To me that suggests that it has a combination of causes. Have I misunderstood?

  • Re: "Do you really think there is a single cause of MS that would show in almost 100% of MS'ers?"

    100% is what Zamboni reported.

    In adult MS EBV is found in 99.9% of cases.

    Yes, if there is a single pivotal factor that triggers or causes MS it needs to found in almost 100% of cases; with a few negatives representing false or incorrect diagnoses. The other option is that MS may be several diseases and not one disease.

  • Re “The other option is that MS may be several diseases and not one disease.”

    This is a new idea to me. Do you think it’s credible? Maybe a topic for a future post…

  • Re “The other option is that MS may be several diseases and not one disease.”

    Yes, would like further elucidation on this. This is a serious curveball Prof G. This is a concept that changes everything. It makes MS more difficut to understand the previous. If it is several diseases then it will be a major set back for all concerned.

  • RE: “Powering such a study would be very difficult given the very low reported incidence, from recent studies, of CCSVI in MS'ers."

    When I had balloon angioplasty for CCSVI, the surgeon used a catheter venogram to inspect my jugular and azygous veins. These veins had the characteristics of CCSVI as described by Dr Zamboni. I saw the venogram images before and after angioplasty and witnessed the improvement in the blood flow. The surgeon has also described this improvement in blood flow in a letter to my neurologist.

    Now the only way, as far as I can see, that your statement fits my experience is either:

    – I’m a statistical rarity.

    – The surgeon was showing me fake images, lied about what he found and preformed venoplasty on veins that were perfectly normal.

    Neither of these options seem likely to me at all.

    In addition the clinic I went to has now treated over 200 patients. So following the logic of your conclusion, I think this would mean that they are either finding a lot of statistical rarities or performing a lot of ‘sham’ procedures.

    The other possibility is that these studies you refer to are duff.

By Prof G

Translate

Categories

Recent Posts

Recent Comments

Archives