Brave Dreams – take home points
CCSVI exists. PTA is useful in restoring blood flow in up to 54% of people and there is a positive effect on MRI from 6-12 months with fewer mean number of new brain lesions in PTA compared to sham group. It is suggested that ‘PTA could affect the dynamic of the blood-brain-barrier.’
The fact that PTA did not restore flow in nearly half of the treatment group is important to consider – this means that they cannot be expected to derive improvements in symptoms or MRI as CCSVI was not adequately treated, undermining the results of the successful procedures.
It was suggested that PTA is safe but ineffective for half of patients, however, there may be benefit for a subgroup of patients with MS. Further research is important to identify which venous abnormalities best respond to PTA so that they can be treated and results compared to sham to give a better indication of its effectiveness. Also, other methods for treating CCSVI must be considered for cases where PTA is insufficient.
Brave Dreams – Summary of publication:
An Italian, multi-centre study considering the efficacy of venous angioplasty for CCSVI in people with Multiple Sclerosis was published on 18 November 2017 by Prof Zamboni et al.
177 people with RRMS who were not on MS disease modifying drugs and who had been diagnosed for less than 15 years were analysed. 62 found ineligible with 26.6% found not to have CCSVI on Doppler Ultrasound.
115 people with RRMS and confirmed CCSVI were randomised with one third receiving a sham (venography only) and two thirds receiving venous percutaneous transluminal angioplasty (PTA). Whilst the average number of new brain lesions at 12 months was not significantly different between the two groups, there were more patients in the treatment arm who were free of new lesions after 6 and 12 months.
Primary end points including walking control, balance, manual dexterity, urinary voidance and visual acuity as well as MRI assessment of new and enlarged cerebral lesions. Secondary endpoints included EDSS score, relapse rate and whether blood flow remained at 12 months.
In the treatment arm blood flow was restored in 54% of people. In the follow up period 6 to 12 months, 83% of the treatment arm were free of new lesions compared to 67% in the sham group. 23% in the PTA group had a relapse over the 12 months compared to 31% in the sham group.
Unfortunately there was not enough people enrolled in the study to provide statistical significance. This is largely due to many patients being unwilling to receive a sham treatment, reluctance of MS centres to recruit participants, media opinions and the availability of angioplasty in private centres.
There were no serious adverse events and 112 people completed the 12-month follow up.
Further papers will be published and we look forward to hearing more.