Evidence map›Paper›PMID 30266886›Full record

Trial reportNeurology2018

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

Anthony L Traboulsee, Lindsay Machan, J Marc Girard, Jean Raymond, Reza Vosoughi, Brian W Hardy, Francois Emond, Jean-Luc Gariepy, Jeffrey N Bone, Gary Siskin and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01864941 (Phase I/II Interventional Clinical Trial of Balloon Venoplasty for Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis Patients), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01864941 phase1 / phase2completednot on this map

Phase I/II Interventional Clinical Trial of Balloon Venoplasty for Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis Patients

TypeinterventionalSponsorUniversity of British ColumbiaRan2013 to 2017Enrolled104ConditionsMultiple SclerosisArmsCatheter venography with balloon venoplasty, Catheter venography with balloon venoplasty and balloon
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Effects of Venous Angioplasty on Cerebral Lesions in Multiple Sclerosis: Expanded Analysis of the Brave Dreams Double-Blind, Sham-Controlled Randomized Trial.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2020
    Trial
  5. Review
  6. Article
  7. A case series of infectious complications in medical tourists requiring hospital admission or outpatient home parenteral therapy.Journal of the Association of Medical Microbiology and Infectious Disease Canada = Journal officiel de l'Association pour la microbiologie medicale et l'infectiologie Canada · 2022
    Article
  8. Article
  9. Review
  10. The antireflux mechanism - Angiographic anatomy and clinical implications.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2020
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Anthony L TraboulseeFrom the University of British Columbia, Departments of Medicine (Neurology) (A.L.T., S.I., J.I., A.D.S.), Radiology (L.M., D.K., D.K.L.), Medical Genetics (A.D.S.), and Statistics (J.N.B.), Vancouver; Centre Hospitalier de l'Université de Montréal (J.M.G., J.R.), Hôpital Notre-Dame, Montreal; Health Sciences Centre (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Québec-Université Laval (F.E., J.-L.G.), Hôpital Enfant-Jésus, Quebec, Canada; and Albany Medical Center (G.S.), NY. t.traboulsee@ubc.ca.
Lindsay MachanFrom the University of British Columbia, Departments of Medicine (Neurology) (A.L.T., S.I., J.I., A.D.S.), Radiology (L.M., D.K., D.K.L.), Medical Genetics (A.D.S.), and Statistics (J.N.B.), Vancouver; Centre Hospitalier de l'Université de Montréal (J.M.G., J.R.), Hôpital Notre-Dame, Montreal; Health Sciences Centre (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Québec-Université Laval (F.E., J.-L.G.), Hôpital Enfant-Jésus, Quebec, Canada; and Albany Medical Center (G.S.), NY.
J Marc GirardFrom the University of British Columbia, Departments of Medicine (Neurology) (A.L.T., S.I., J.I., A.D.S.), Radiology (L.M., D.K., D.K.L.), Medical Genetics (A.D.S.), and Statistics (J.N.B.), Vancouver; Centre Hospitalier de l'Université de Montréal (J.M.G., J.R.), Hôpital Notre-Dame, Montreal; Health Sciences Centre (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Québec-Université Laval (F.E., J.-L.G.), Hôpital Enfant-Jésus, Quebec, Canada; and Albany Medical Center (G.S.), NY.
Jean RaymondFrom the University of British Columbia, Departments of Medicine (Neurology) (A.L.T., S.I., J.I., A.D.S.), Radiology (L.M., D.K., D.K.L.), Medical Genetics (A.D.S.), and Statistics (J.N.B.), Vancouver; Centre Hospitalier de l'Université de Montréal (J.M.G., J.R.), Hôpital Notre-Dame, Montreal; Health Sciences Centre (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Québec-Université Laval (F.E., J.-L.G.), Hôpital Enfant-Jésus, Quebec, Canada; and Albany Medical Center (G.S.), NY.
Reza VosoughiFrom the University of British Columbia, Departments of Medicine (Neurology) (A.L.T., S.I., J.I., A.D.S.), Radiology (L.M., D.K., D.K.L.), Medical Genetics (A.D.S.), and Statistics (J.N.B.), Vancouver; Centre Hospitalier de l'Université de Montréal (J.M.G., J.R.), Hôpital Notre-Dame, Montreal; Health Sciences Centre (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Québec-Université Laval (F.E., J.-L.G.), Hôpital Enfant-Jésus, Quebec, Canada; and Albany Medical Center (G.S.), NY.
Brian W HardyFrom the University of British Columbia, Departments of Medicine (Neurology) (A.L.T., S.I., J.I., A.D.S.), Radiology (L.M., D.K., D.K.L.), Medical Genetics (A.D.S.), and Statistics (J.N.B.), Vancouver; Centre Hospitalier de l'Université de Montréal (J.M.G., J.R.), Hôpital Notre-Dame, Montreal; Health Sciences Centre (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Québec-Université Laval (F.E., J.-L.G.), Hôpital Enfant-Jésus, Quebec, Canada; and Albany Medical Center (G.S.), NY.
Francois EmondFrom the University of British Columbia, Departments of Medicine (Neurology) (A.L.T., S.I., J.I., A.D.S.), Radiology (L.M., D.K., D.K.L.), Medical Genetics (A.D.S.), and Statistics (J.N.B.), Vancouver; Centre Hospitalier de l'Université de Montréal (J.M.G., J.R.), Hôpital Notre-Dame, Montreal; Health Sciences Centre (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Québec-Université Laval (F.E., J.-L.G.), Hôpital Enfant-Jésus, Quebec, Canada; and Albany Medical Center (G.S.), NY.
Jean-Luc GariepyFrom the University of British Columbia, Departments of Medicine (Neurology) (A.L.T., S.I., J.I., A.D.S.), Radiology (L.M., D.K., D.K.L.), Medical Genetics (A.D.S.), and Statistics (J.N.B.), Vancouver; Centre Hospitalier de l'Université de Montréal (J.M.G., J.R.), Hôpital Notre-Dame, Montreal; Health Sciences Centre (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Québec-Université Laval (F.E., J.-L.G.), Hôpital Enfant-Jésus, Quebec, Canada; and Albany Medical Center (G.S.), NY.
Jeffrey N BoneFrom the University of British Columbia, Departments of Medicine (Neurology) (A.L.T., S.I., J.I., A.D.S.), Radiology (L.M., D.K., D.K.L.), Medical Genetics (A.D.S.), and Statistics (J.N.B.), Vancouver; Centre Hospitalier de l'Université de Montréal (J.M.G., J.R.), Hôpital Notre-Dame, Montreal; Health Sciences Centre (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Québec-Université Laval (F.E., J.-L.G.), Hôpital Enfant-Jésus, Quebec, Canada; and Albany Medical Center (G.S.), NY.
Gary SiskinFrom the University of British Columbia, Departments of Medicine (Neurology) (A.L.T., S.I., J.I., A.D.S.), Radiology (L.M., D.K., D.K.L.), Medical Genetics (A.D.S.), and Statistics (J.N.B.), Vancouver; Centre Hospitalier de l'Université de Montréal (J.M.G., J.R.), Hôpital Notre-Dame, Montreal; Health Sciences Centre (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Québec-Université Laval (F.E., J.-L.G.), Hôpital Enfant-Jésus, Quebec, Canada; and Albany Medical Center (G.S.), NY.
Darren KlassFrom the University of British Columbia, Departments of Medicine (Neurology) (A.L.T., S.I., J.I., A.D.S.), Radiology (L.M., D.K., D.K.L.), Medical Genetics (A.D.S.), and Statistics (J.N.B.), Vancouver; Centre Hospitalier de l'Université de Montréal (J.M.G., J.R.), Hôpital Notre-Dame, Montreal; Health Sciences Centre (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Québec-Université Laval (F.E., J.-L.G.), Hôpital Enfant-Jésus, Quebec, Canada; and Albany Medical Center (G.S.), NY.
Saul IsserowFrom the University of British Columbia, Departments of Medicine (Neurology) (A.L.T., S.I., J.I., A.D.S.), Radiology (L.M., D.K., D.K.L.), Medical Genetics (A.D.S.), and Statistics (J.N.B.), Vancouver; Centre Hospitalier de l'Université de Montréal (J.M.G., J.R.), Hôpital Notre-Dame, Montreal; Health Sciences Centre (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Québec-Université Laval (F.E., J.-L.G.), Hôpital Enfant-Jésus, Quebec, Canada; and Albany Medical Center (G.S.), NY.
Judy IllesFrom the University of British Columbia, Departments of Medicine (Neurology) (A.L.T., S.I., J.I., A.D.S.), Radiology (L.M., D.K., D.K.L.), Medical Genetics (A.D.S.), and Statistics (J.N.B.), Vancouver; Centre Hospitalier de l'Université de Montréal (J.M.G., J.R.), Hôpital Notre-Dame, Montreal; Health Sciences Centre (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Québec-Université Laval (F.E., J.-L.G.), Hôpital Enfant-Jésus, Quebec, Canada; and Albany Medical Center (G.S.), NY.
A Dessa SadovnickFrom the University of British Columbia, Departments of Medicine (Neurology) (A.L.T., S.I., J.I., A.D.S.), Radiology (L.M., D.K., D.K.L.), Medical Genetics (A.D.S.), and Statistics (J.N.B.), Vancouver; Centre Hospitalier de l'Université de Montréal (J.M.G., J.R.), Hôpital Notre-Dame, Montreal; Health Sciences Centre (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Québec-Université Laval (F.E., J.-L.G.), Hôpital Enfant-Jésus, Quebec, Canada; and Albany Medical Center (G.S.), NY.
David K LiFrom the University of British Columbia, Departments of Medicine (Neurology) (A.L.T., S.I., J.I., A.D.S.), Radiology (L.M., D.K., D.K.L.), Medical Genetics (A.D.S.), and Statistics (J.N.B.), Vancouver; Centre Hospitalier de l'Université de Montréal (J.M.G., J.R.), Hôpital Notre-Dame, Montreal; Health Sciences Centre (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Québec-Université Laval (F.E., J.-L.G.), Hôpital Enfant-Jésus, Quebec, Canada; and Albany Medical Center (G.S.), NY.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine the safety and efficacy of balloon vs sham venoplasty of narrowing of the extracranial jugular and azygos veins in multiple sclerosis (MS).

methodsPatients with relapsing or progressive MS were screened using clinical and ultrasound criteria. After confirmation of >50% narrowing by venography, participants were randomized 1:1 to receive balloon or sham venoplasty of all stenoses and were followed for 48 weeks. Participants and research staff were blinded to intervention allocation. The primary safety outcome was the number of adverse events (AEs) during 48 weeks. The primary efficacy outcome was the change from baseline to week 48 in the patient-reported outcome MS Quality of Life-54 (MSQOL-54) questionnaire. Standardized clinical and MRI outcomes were also evaluated.

resultsOne hundred four participants were randomized (55 sham; 49 venoplasty) and 103 completed 48 weeks of follow-up. Twenty-three sham and 21 venoplasty participants reported at least 1 AE; one sham (2%) and 5 (10%) venoplasty participants had a serious AE. The mean improvement in MSQOL-54 physical score was +1.3 (sham) and +1.4 (venoplasty) (

conclusionsOur data do not support the continued use of venoplasty of extracranial jugular and/or azygous venous narrowing to improve patient-reported outcomes, chronic MS symptoms, or the disease course of MS. CLINICALTRIALSGOV IDENTIFIER: NCT01864941. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with MS, balloon venoplasty of extracranial jugular and azygous veins is not beneficial in improving patient-reported, standardized clinical, or MRI outcomes.

Indexed as

AdultAgedAngioplasty, BalloonAzygos VeinDouble-Blind MethodFemaleHumansJugular VeinsMaleMiddle AgedMultiple Sclerosis

Identifiers

PMID30266886
PMCPMC6207414

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.