#MSResearch CCSVI trial shows no evidence of action
OBJECTIVE: We report the results of the investigation of safety and efficacy of venous angioplasty in patients with multiple sclerosis (MS) with findings of extracranial venous anomalies, considered hallmarks of chronic cerebrospinal venous insufficiency (CCSVI), in a 2-phase study (ClinicalTrials.gov NCT01450072).
METHODS: Phase 1 was an open-label safety study (10 patients); phase 2 was sham-controlled, randomized, and double-blind (10 sham procedure, 9 treated). All study patients fulfilled venous hemodynamic screening criteria indicative of CCSVI. Assessment was at 1, 3, and 6 months postprocedure 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.
RESULTS: 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 haemodynamic 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 nonsignificant 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.
CONCLUSION: Venous angioplasty is not an effective treatment for MS over the short term and may exacerbate underlying disease activity.
CLASSIFICATION OF EVIDENCE: This is a Class I study demonstrating that clinical and imaging outcomes are no better or worse in patients with MS identified with venous outflow restriction who receive venous angioplasty compared to sham controls who do not receive angioplasty. This study also includes a Class IV phase 1 study of safety in 10 patients receiving the angioplasty procedure.
Time to send the book back to the library for shredding?
Normally we wait until CCSVI saturday to post on all things CCSVI.
However this is important data. The neurologists appear to be crowing.
Epub: Bourdette and Cohen. Vennous angioplasty for “CCSVI” in multiple sclerosis: Ending a therapeutic misadventure. Neurology. 2014 Jun 27. pii: 10.1212/WNL.0000000000000651.
ProfG may comment on this later..he is busy, but at his own risk as any comments seem to bring out the trolls. So when you think about making those abusive comments…take a deep breath and stop it!. Remember we have control of all comments.
In an small study there is no treatment effect.
If CCSVI was a wonder treatment then it would be seen in all, it was not. In the first arm of the study aspects of CCSVI were reduced, but in the second phase which showed the failure this did not happen. Furthermore there was a trend for disease worsening in terms of MRI/clinical activity in the second phase. However, this was not statistically significant and whilst news has been that this worsens MS, the data is not good enough to show this.
This study was performed by “Pro-CCSVIers”.. However it does not prove it does not work..but maybe the writing is on the wall.
However, it suggests that their are better ways of spending your money.