Evidence map›Paper›PMID 31735108›Full record

Trial reportJournal of endovascular therapy : an official journal of the International Society of Endovascular Specialists2020

Effects of Venous Angioplasty on Cerebral Lesions in Multiple Sclerosis: Expanded Analysis of the Brave Dreams Double-Blind, Sham-Controlled Randomized Trial.

Paolo Zamboni, Roberto Galeotti, Fabrizio Salvi, Alessia Giaquinta, Carlo Setacci, Salvatore Alborino, Giuseppe Guzzardi, Salvatore J Sclafani, Elisa Maietti, Pierfrancesco Veroux and 1 more

Erratum issuedOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.8field-weighted citation impact, top 9% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 32 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 2 countries.

Paolo ZamboniHUB Center for Venous and Lymphatics Disorders of the Emilia Romagna Region, S. Anna University Hospital, Ferrara, Italy.ORCID 0000-0002-7107-888X
Roberto GaleottiUnit of Interventional Radiology, S. Anna University Hospital, Ferrara, Italy.
Fabrizio SalviIRCCS of the Neurosciences, Bellaria Hospital, Bologna, Italy.
Alessia GiaquintaUnit of Vascular Surgery and Transplantation, University of Catania, Italy.
Carlo SetacciUnit of Vascular Surgery, University of Siena, Siena, Italy.
Salvatore AlborinoUnit of Radiology, Macerata Hospital, ASUR Marche, Italy.
Giuseppe GuzzardiUnit of Interventional Radiology, Ospedale Maggiore, Novara, Italy.
Salvatore J SclafaniDepartment of Radiology, New York State University in Brooklyn, New York, USA.
Elisa MaiettiDepartment of Biomedical and Neuromotor Sciences, University of Bologna Center for Clinical Epidemiology, School of Medicine, University of Ferrara, Italy.
Pierfrancesco VerouxUnit of Vascular Surgery and Transplantation, University of Catania, Italy.
Brave Dreams Research Group
University of Ferrara · ITOspedale Bellaria · ITOspedale Maggiore · ITUniversity of Catania · ITOspedale di MacerataState University of New York · USUniversity of Siena · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate if jugular vein flow restoration in various venographic defects indicative of chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis (MS) patients can have positive effects on cerebral lesions identified using magnetic resonance imaging (MRI). MATERIALS AND

methodsThe Brave Dreams trial (

resultsOf the 130 patients enrolled, 125 (96%) completed the 12-month MRI follow-up. Analysis showed that the likelihood of being free of new cerebral lesions at 1 year was significantly higher after venoplasty compared to the sham group (RR 1.42, 95% CI 1.00 to 2.01, p=0.032). Patients with favorable venograms had a significantly higher probability of being free of new cerebral lesions than patients with unfavorable venograms (RR 1.82, 95% CI 1.17 to 2.83, p=0.005) or patients in the sham arm (RR 1.66, 95% CI 1.16 to 2.37, p=0.005).

conclusionExpanded analysis of the Brave Dreams data that included secondary/progressive MS patients in addition to the relapsing/remitting patients analyzed previously showed that venoplasty decreases new cerebral lesions at 1 year. Secondary analysis confirmed the efficacy of the Giaquinta grading system in selecting patients appropriate for venoplasty who were more likely to be free from accumulation of new cerebral lesions at MRI.

Indexed as

Angioplasty, BalloonAdolescentAdultAgedBrainCerebrovascular DisordersChronic DiseaseDouble-Blind MethodFemaleHumansItalyMagnetic Resonance ImagingMaleMiddle AgedMultiple Sclerosis, Chronic ProgressiveMultiple Sclerosis, Relapsing-Remittingangioplastycerebral drainagecerebral lesionchronic cerebrospinal venous insufficiencyecho Dopplerinternal jugular veinjugular flowmagnetic resonance imagingmultiple sclerosisstenosisvein defectsvenographyvenoplasty

Identifiers

PMID31735108
PMCPMC6970429
OpenAlexW2989464090

What Socratic holds

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LicenceCC BY-NC
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Registered trials

None linked

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 Socratic graph.