Venoplasty of extracranial jugular and/or azygous venous narrowing does not appear to improve patient-reported outcomes, chronic symptoms, or the disease course of multiple sclerosis (MS).
The findings from a Canadian study appear to confirm other evidence that the controversial chronic cerebrospinal venous insufficiency (CCSVI) hypothesis for MS is flawed.
The study randomised 104 patients with MS to either venoplasty or a sham procedure. Half of the patients with relapsing-remitting disease and 72% of patients with either secondary progressive or primary progressive disease had vessels with >50% narrowing.
Patients in both groups reported a transient improvement in quality of life (MSQOL) scores however there was no significant difference between the groups in improvement from baseline to week 48.
There was also no improvement in MS Functional Composite score (MSFC) or Expanded Disability Status Scale (EDSS) from baseline to week 48 in either group of patients.
“This would argue against venoplasty having a disease-modifying mechanism of action,” said the study investigators, led by neurologist Dr Anthony L. Traboulsee from the University of British Columbia.
Symptoms of CCSVI such as limb temperature and colour or brain fog were also similar in both groups.
Adverse events were similar in both groups although serious adverse events including a MI and pulmonary embolism were more common in the venoplasty group.
The authors said extracranial venous stenosis continues to be proposed as a pathogenic disorder for a variety of neurologic conditions.
“It is not uncommon for patients to experience improvements in their symptoms with intervention, especially when expectations are high.”
However uncontrolled case series can erroneously suggest a benefit from novel but ineffective therapies, they said.
“This large randomized, double-blind, multicenter clinical trial failed to show superiority of venoplasty compared to sham intervention on patient-reported, clinical, and MRI outcomes.”
An editorial, also published in Neurology, said the study was ‘hopefully the final milestone of evidence that the CCSVI theory in MS is flat wrong in terms of disease pathophysiology and for therapeutic interventions’.
“We do not need more data on this wrong and misleading CCSVI concept. There are other much more relevant and burning research questions that need our attention and allocation of resources and funding.”
The limbic tried but failed to find an Australian neurologist prepared to comment on the study or CCSVI.
“This issue has long blown over / been debunked, and my view is the less media attention it is given, the better,” was the response from one leading neurologist.
Nevertheless, a RCT of percutaneous transluminal angioplasty for extracranial vein stenosis in MS is still underway at the Alfred Hospital, the limbic was told.