Negative randomized trial may be last chapter for venoplasty in MS

  • Traboulsee AL & al.
  • Neurology
  • 28 Sep 2018

  • curated by Susan London
  • Clinical Essentials
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Takeaway

  • Compared with a sham procedure, balloon venoplasty of stenoses in the extracranial jugular and azygos veins did not improve 48-week self-reported and other clinical outcomes in patients with multiple sclerosis (MS).

Why this matters

  • Chronic cerebrospinal venous insufficiency (CCSVI) proposed to play role in pathogenesis.
  • Venoplasty is popular among patients, but randomized data limited.

Key results

  • Venoplasty group had higher rate of serious adverse events than sham group (10% vs 2%), but judged unrelated to procedure.
  • Venoplasty and sham groups similar on:
    • Rate of adverse events (43% vs 42%; P=1.0);
    • Improvement in MSQOL-54 physical score (+1.4 vs +1.3; P=.95);
    • Change in MSQOL-54 mental score (−0.8 vs +1.2; P=.55);
    • Change in fatigue severity score (+0.1 vs +0.2; P=.65);
    • Change in pain score (−0.2 vs +0.1; P=.19);
    • Rate of 3-month confirmed disability progression (2% vs 5%; P=.62); and
    • Relapse rate (10% vs 11%; P=1.0).
  • Findings consistent across MS types.

Expert comment

  • Editorial authors write, “This study is another and hopefully the final milestone of evidence that the CCSVI theory in MS is flat wrong in terms of disease pathophysiology and for therapeutic interventions.”

Study design

  • Canadian phase 2 randomized controlled trial: 104 patients with relapsing or progressive confirmed >50% narrowing by venography of extracranial jugular, azygos veins.
  • Randomization: double-blind balloon or sham of all stenoses.
  • Main outcomes: patient-reported MSQOL-54 score, adverse events.
  • Funding: Canadian Institutes of Health Research; others.

Limitations

  • Stents not used.
  • Unclear generalizability.

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