Editors' note: Safety and efficacy of venoplasty in MS: A randomized, double-blind, sham-controlled phase II trial

Abstract

In the article “Safety and efficacy of venoplasty in MS: A randomized, double-blind, sham-controlled phase II trial”, Traboulsee et al. compared balloon or sham venoplasty of extracranial jugular and/or azygous venous narrowing (>50% by venography) in 104 participants with relapsing or progressive MS followed for 48 weeks. They concluded that their data did not support the continued use of venoplasty to improve patient-reported outcomes, chronic symptoms, or disease course of MS. In response, Juurlink et al. note that no venous flow data were presented, positing that there may be therapeutic benefits in those patients who achieve better flow after venoplasty. They also highlight a discrepancy between numbers of new MRI-detectable lesions reported in the Results section vs table 3 of the article. Replying to these comments, Drs. Traboulsee et al. note that vessel patency and venous flow through the narrowing were confirmed with postprocedural venography, but caution that quantitative measures of venous flow may be confounded by multiple factors. They argue that post hoc analysis of small subgroups (as in a previous study by Drs. Zamboni et al.) will have insufficient power and is prone to erroneous interpretation. They clarify that the numbers in table 3 are correct. In another response, Dr. Rasman perceives a lack of MRI data in the article and contrasts the study's mixing of relapsing and progressive MS with the inclusion of only relapsing-remitting MS in the Brave Dreams trial. Dr. Rasman also contends that the relatively older population with longer disease duration in this study is unsuitable for venous percutaneous transluminal angioplasty (PTA) and argues that gastrointestinal symptoms and anxiety should not have been attributed to PTA. Finally, Dr. Bruno reports a lower rate of adverse events from PTA of the internal jugular and azygous veins in their own practice. The authors did not respond to these additional comments. In the article “Safety and efficacy of venoplasty in MS: A randomized, double-blind, sham-controlled phase II trial”, Traboulsee et al. compared balloon or sham venoplasty of extracranial jugular and/or azygous venous narrowing (>50% by venography) in 104 participants with relapsing or progressive MS followed for 48 weeks.