PMID- 30266886
OWN - NLM
STAT- MEDLINE
DCOM- 20190906
LR  - 20190906
IS  - 1526-632X (Electronic)
IS  - 0028-3878 (Print)
IS  - 0028-3878 (Linking)
VI  - 91
IP  - 18
DP  - 2018 Oct 30
TI  - Safety and efficacy of venoplasty in MS: A randomized, double-blind, 
      sham-controlled phase II trial.
PG  - e1660-e1668
LID - 10.1212/WNL.0000000000006423 [doi]
AB  - OBJECTIVE: To determine the safety and efficacy of balloon vs sham venoplasty of 
      narrowing of the extracranial jugular and azygos veins in multiple sclerosis 
      (MS). METHODS: Patients 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. RESULTS: One 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) (p = 0.95); 
      MSQOL-54 mental score was +1.2 (sham) and -0.8 (venoplasty) (p = 0.55). 
      CONCLUSIONS: Our 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.
CI  - Copyright (c) 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on 
      behalf of the American Academy of Neurology.
FAU - Traboulsee, Anthony L
AU  - Traboulsee AL
AD  - From 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'Universite 
      de Montreal (J.M.G., J.R.), Hopital Notre-Dame, Montreal; Health Sciences Centre 
      (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Quebec-Universite 
      Laval (F.E., J.-L.G.), Hopital Enfant-Jesus, Quebec, Canada; and Albany Medical 
      Center (G.S.), NY. t.traboulsee@ubc.ca.
FAU - Machan, Lindsay
AU  - Machan L
AD  - From 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'Universite 
      de Montreal (J.M.G., J.R.), Hopital Notre-Dame, Montreal; Health Sciences Centre 
      (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Quebec-Universite 
      Laval (F.E., J.-L.G.), Hopital Enfant-Jesus, Quebec, Canada; and Albany Medical 
      Center (G.S.), NY.
FAU - Girard, J Marc
AU  - Girard JM
AD  - From 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'Universite 
      de Montreal (J.M.G., J.R.), Hopital Notre-Dame, Montreal; Health Sciences Centre 
      (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Quebec-Universite 
      Laval (F.E., J.-L.G.), Hopital Enfant-Jesus, Quebec, Canada; and Albany Medical 
      Center (G.S.), NY.
FAU - Raymond, Jean
AU  - Raymond J
AD  - From 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'Universite 
      de Montreal (J.M.G., J.R.), Hopital Notre-Dame, Montreal; Health Sciences Centre 
      (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Quebec-Universite 
      Laval (F.E., J.-L.G.), Hopital Enfant-Jesus, Quebec, Canada; and Albany Medical 
      Center (G.S.), NY.
FAU - Vosoughi, Reza
AU  - Vosoughi R
AD  - From 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'Universite 
      de Montreal (J.M.G., J.R.), Hopital Notre-Dame, Montreal; Health Sciences Centre 
      (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Quebec-Universite 
      Laval (F.E., J.-L.G.), Hopital Enfant-Jesus, Quebec, Canada; and Albany Medical 
      Center (G.S.), NY.
FAU - Hardy, Brian W
AU  - Hardy BW
AD  - From 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'Universite 
      de Montreal (J.M.G., J.R.), Hopital Notre-Dame, Montreal; Health Sciences Centre 
      (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Quebec-Universite 
      Laval (F.E., J.-L.G.), Hopital Enfant-Jesus, Quebec, Canada; and Albany Medical 
      Center (G.S.), NY.
FAU - Emond, Francois
AU  - Emond F
AD  - From 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'Universite 
      de Montreal (J.M.G., J.R.), Hopital Notre-Dame, Montreal; Health Sciences Centre 
      (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Quebec-Universite 
      Laval (F.E., J.-L.G.), Hopital Enfant-Jesus, Quebec, Canada; and Albany Medical 
      Center (G.S.), NY.
FAU - Gariepy, Jean-Luc
AU  - Gariepy JL
AD  - From 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'Universite 
      de Montreal (J.M.G., J.R.), Hopital Notre-Dame, Montreal; Health Sciences Centre 
      (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Quebec-Universite 
      Laval (F.E., J.-L.G.), Hopital Enfant-Jesus, Quebec, Canada; and Albany Medical 
      Center (G.S.), NY.
FAU - Bone, Jeffrey N
AU  - Bone JN
AD  - From 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'Universite 
      de Montreal (J.M.G., J.R.), Hopital Notre-Dame, Montreal; Health Sciences Centre 
      (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Quebec-Universite 
      Laval (F.E., J.-L.G.), Hopital Enfant-Jesus, Quebec, Canada; and Albany Medical 
      Center (G.S.), NY.
FAU - Siskin, Gary
AU  - Siskin G
AD  - From 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'Universite 
      de Montreal (J.M.G., J.R.), Hopital Notre-Dame, Montreal; Health Sciences Centre 
      (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Quebec-Universite 
      Laval (F.E., J.-L.G.), Hopital Enfant-Jesus, Quebec, Canada; and Albany Medical 
      Center (G.S.), NY.
FAU - Klass, Darren
AU  - Klass D
AD  - From 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'Universite 
      de Montreal (J.M.G., J.R.), Hopital Notre-Dame, Montreal; Health Sciences Centre 
      (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Quebec-Universite 
      Laval (F.E., J.-L.G.), Hopital Enfant-Jesus, Quebec, Canada; and Albany Medical 
      Center (G.S.), NY.
FAU - Isserow, Saul
AU  - Isserow S
AD  - From 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'Universite 
      de Montreal (J.M.G., J.R.), Hopital Notre-Dame, Montreal; Health Sciences Centre 
      (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Quebec-Universite 
      Laval (F.E., J.-L.G.), Hopital Enfant-Jesus, Quebec, Canada; and Albany Medical 
      Center (G.S.), NY.
FAU - Illes, Judy
AU  - Illes J
AD  - From 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'Universite 
      de Montreal (J.M.G., J.R.), Hopital Notre-Dame, Montreal; Health Sciences Centre 
      (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Quebec-Universite 
      Laval (F.E., J.-L.G.), Hopital Enfant-Jesus, Quebec, Canada; and Albany Medical 
      Center (G.S.), NY.
FAU - Sadovnick, A Dessa
AU  - Sadovnick AD
AD  - From 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'Universite 
      de Montreal (J.M.G., J.R.), Hopital Notre-Dame, Montreal; Health Sciences Centre 
      (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Quebec-Universite 
      Laval (F.E., J.-L.G.), Hopital Enfant-Jesus, Quebec, Canada; and Albany Medical 
      Center (G.S.), NY.
FAU - Li, David K
AU  - Li DK
AD  - From 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'Universite 
      de Montreal (J.M.G., J.R.), Hopital Notre-Dame, Montreal; Health Sciences Centre 
      (R.V., B.W.H.), Winnipeg; Centre Hospitalier Universitaire de Quebec-Universite 
      Laval (F.E., J.-L.G.), Hopital Enfant-Jesus, Quebec, Canada; and Albany Medical 
      Center (G.S.), NY.
LA  - eng
SI  - ClinicalTrials.gov/NCT01864941
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180928
PL  - United States
TA  - Neurology
JT  - Neurology
JID - 0401060
SB  - IM
CIN - Neurology. 2018 Oct 30;91(18):815-816. PMID: 30266888
CIN - Neurology. 2019 Aug 13;93(7):319-320. PMID: 31405939
CIN - Neurology. 2019 Aug 13;93(7):320. PMID: 31405940
CIN - Neurology. 2019 Aug 13;93(7):320-321. PMID: 31405941
CIN - Neurology. 2019 Aug 13;93(7):321. PMID: 31405942
MH  - Adult
MH  - Aged
MH  - Angioplasty, Balloon/*methods
MH  - Azygos Vein/*surgery
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Jugular Veins/*surgery
MH  - Male
MH  - Middle Aged
MH  - Multiple Sclerosis/*therapy
PMC - PMC6207414
EDAT- 2018/09/30 06:00
MHDA- 2019/09/07 06:00
PMCR- 2018/10/30
CRDT- 2018/09/30 06:00
PHST- 2017/09/29 00:00 [received]
PHST- 2018/07/19 00:00 [accepted]
PHST- 2018/09/30 06:00 [pubmed]
PHST- 2019/09/07 06:00 [medline]
PHST- 2018/09/30 06:00 [entrez]
PHST- 2018/10/30 00:00 [pmc-release]
AID - WNL.0000000000006423 [pii]
AID - NEUROLOGY2017853101 [pii]
AID - 10.1212/WNL.0000000000006423 [doi]
PST - ppublish
SO  - Neurology. 2018 Oct 30;91(18):e1660-e1668. doi: 10.1212/WNL.0000000000006423. 
      Epub 2018 Sep 28.