Evidence map›Paper›PMID 24975855›Full record

Trial reportNeurology2014

Prospective randomized trial of venous angioplasty in MS (PREMiSe).

Adnan H Siddiqui, Robert Zivadinov, Ralph H B Benedict, Yuval Karmon, Jihnhee Yu, Mary L Hartney, Karen L Marr, Vesela Valnarov, Cheryl L Kennedy, Murali Ramanathan and 7 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01450072 (Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE), which is not on this map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
4.5field-weighted citation impact, top 6% of its field
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.

NCT01450072 nacompletednot on this map

Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE

TypeinterventionalSponsorState University of New York at BuffaloRan2010 to 2012Enrolled20ConditionsMultiple SclerosisArmsSelective Venography followed by therapeutic balloon angioplasty, Control arm
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. 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
  4. Trial
  5. Trial
  6. Article
  7. Review
  8. Article
  9. Observational
  10. Understanding jugular venous outflow disturbance.CNS neuroscience & therapeutics · 2018
    Review
  11. Article
  12. Review
  13. Review
  14. Article
  15. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 1 institution in 1 country.

Adnan H SiddiquiFrom the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY. asiddiqui@ubns.com rzivadinov@bnac.net.
Robert ZivadinovFrom the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY. asiddiqui@ubns.com rzivadinov@bnac.net.
Ralph H B BenedictFrom the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY.
Yuval KarmonFrom the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY.
Jihnhee YuFrom the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY.
Mary L HartneyFrom the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY.
Karen L MarrFrom the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY.
Vesela ValnarovFrom the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY.
Cheryl L KennedyFrom the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY.
Murali RamanathanFrom the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY.
Deepa P RamasamyFrom the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY.
Kresimir DolicFrom the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY.
David W HojnackiFrom the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY.
Ellen CarlFrom the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY.
Elad I LevyFrom the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY.
L Nelson HopkinsFrom the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY.
Bianca Weinstock-GuttmanFrom the Departments of Neurosurgery and Radiology, The Jacobs Neurological Institute (A.H.S., Y.K., M.L.H., E.I.L., L.N.H.), and the Departments of Neurology (R.Z., R.H.B.B., D.W.H., B.W.-G.), Biostatistics (J.Y.), and Pharmaceutical Sciences (M.R.), University at Buffalo, State University of New York; and the Buffalo Neuroimaging Analysis Center (R.Z., K.L.M., V.V., C.L.K., D.P.R., K.D., E.C.), NY.
Buffalo Psychiatric Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveWe 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).

methodsPhase 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.

resultsNo 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.

conclusionVenous 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.

Indexed as

AdultAngioplastyDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedMultiple SclerosisProspective StudiesVenous Insufficiency

Identifiers

PMID24975855
PMCPMC4132574
OpenAlexW2150583762

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.