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Abstract
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 hemodynamic 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.
GLOSSARY
- AE=
- adverse event;
- ANCOVA=
- analysis of covariance;
- ANOVA=
- analysis of variance;
- CCSVI=
- chronic cerebrospinal venous insufficiency;
- CE=
- contrast-enhancing;
- CV=
- catheter venography;
- EDSS=
- Expanded Disability Status Scale;
- IJV=
- internal jugular vein;
- IVUS=
- intravascular ultrasound;
- MS=
- multiple sclerosis;
- MSFC=
- MS Functional Composite;
- PREMiSe=
- Prospective Randomized Endovascular Therapy in MS;
- QoL=
- quality of life;
- VH=
- venous hemodynamic;
- VHISS=
- venous hemodynamic insufficiency severity score
Footnotes
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Editorial, page 388
Supplemental data at Neurology.org
- Received September 30, 2013.
- Accepted in final form March 17, 2014.
- © 2014 American Academy of Neurology
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