Evidence map›Paper›PMID 31484697›Full record

Trial reportJournal of neurointerventional surgery2020

Peri-procedural stroke or death in stenting of symptomatic severe intracranial stenosis.

Shadi Yaghi, Pooja Khatri, Adam de Havenon, Sharon Yeatts, Andrew D Chang, Shawna Cutting, Brian Mac Grory, Tina Burton, Mahesh V Jayaraman, Ryan A McTaggart and 8 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neurointerventional surgery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00576693 (Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

NCT00576693 phase3completednot on this map

Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis

TypeinterventionalSponsorMedical University of South CarolinaRan2008 to 2013Enrolled451ConditionsIschemic StrokeArmsintracranial angioplasty and stenting, intensive medical management
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Review
  6. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Shadi YaghiDepartment of Neurology, New York Langone Health, New York, NY, USA.
Pooja KhatriDepartment of Neurology, University of Cincinnati, Cincinnati, Ohio, USA.
Adam de HavenonDepartment of Neurology, University of Utah, Salt Lake City, Utah, USA.
Sharon YeattsDepartment of Biostatistics, Bioinformatics and Epidemiology, Medical University of South Carolina, Charleston, South Carolina, USA.
Andrew D ChangDepartment of Neurology, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.
Shawna CuttingDepartment of Neurology, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.
Brian Mac GroryDepartment of Neurology, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.
Tina BurtonDepartment of Neurology, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.
Mahesh V JayaramanDepartment of Diagnostic Imaging, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.
Ryan A McTaggartDepartment of Neurosurgery, Cleveland Clinic Florida, Weston, Florida, USA.
David FiorellaDepartment of Neurosurgery, Stony Brook University, Stony Brook, New York, USA.ORCID http://orcid.org/0000-0002-2677-8780
Colin DerdeynDepartment of Radiology and Interventional Radiology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA.
Osama O ZaidatDepartment of Neuroscience, St Vincent Mercy Hospital, Toledo, Ohio, USA.ORCID http://orcid.org/0000-0003-4881-4698
Seena DehkharghaniNYU Langone Health, New York, New York, USA.
Sepideh Amin-HanjaniNeurosurgery, University of Illinois, Chicago, Illinois, USA.
Karen FurieDepartment of Neurology, Rhode Island Hospital, Providence, Rhode Island, USA.
Shyam PrahbakaranNeurology, University of Chicago, Chicago, Illinois, USA.
David LiebeskindDepartment of Neurology, UCLA, Los Angeles, California, USA.

Funding

NINDS NIH HHS K23 NS105924NINDS NIH HHS U01 NS058728
6 · The paper itself

Abstract

background and purposeThere are limited data on predictors of 30-day stroke or death in patients with symptomatic intracranial atherosclerosis (sICAS) undergoing stenting. We aim to determine the factors associated with stroke or death at 30 days in the stenting arm of the SAMMPRIS trial.

methodsThis is a post-hoc analysis of the SAMMPRIS trial including patients who underwent angioplasty/stenting. We compared patient-specific variables, lesion-specific variables, procedure-specific variables, and FDA-approved indications between patients with and without the primary outcome (stroke or death at 30 days). Logistic regression analyses were performed to evaluate associations with the primary outcome.

resultsWe identified 213 patients, 30 of whom (14.1%) met the primary outcome. Smoking status and lesion length were associated with the primary outcome: the odds of stroke or death for non-smokers versus smokers (adjusted OR 4.46, 95% CI 1.79 to 11.1, p=0.001) and for increasing lesion length in millimeters (adjusted OR 1.20, 95% CI 1.02 to 1.39, p=0.029). These had a modest predictive value: absence of smoking history (sensitivity 66.7%, specificity 65.4%) and lesion length (area under curve 0.606). Furthermore, event rates were not significantly different between patients with and without the FDA-approved indication for stenting (15.9% vs 12%, p=0.437).

conclusionIn SAMMPRIS patients who underwent angioplasty/stenting, neither clinical and neuroimaging variables nor the FDA indication for stenting reliably predicted the primary outcome. Further work in identifying reliable biomarkers of stroke/death in patients with sICAS is needed before considering new clinical trials of stenting. TRIAL REGISTRATION NUMBER: SAMMPRIS NCT00576693; Results.

Indexed as

Severity of Illness IndexAgedAngioplastyCerebrovascular DisordersFemaleHumansIntracranial ArteriosclerosisMaleMiddle AgedMortalityPostoperative ComplicationsRisk FactorsStentsStrokeangioplastyatherosclerosisstentstroke

Identifiers

PMID31484697
PMCPMC8022354

What Socratic holds

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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 Socratic graph.