Evidence map›Paper›PMID 33493046›Full record

ArticleStroke2021

Absence of Consistent Sex Differences in Outcomes From Symptomatic Carotid Endarterectomy and Stenting Randomized Trials.

Virginia J Howard, Ale Algra, George Howard, Leo H Bonati, Gert J de Borst, Richard Bulbulia, David Calvet, Hans-Henning Eckstein, Gustav Fraedrich, Jacoba P Greving and 8 more

2 registry-linked trialsOpen access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Stroke, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.6field-weighted citation impact, top 16% 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.

NCT00004732 nacompletednot on this map

Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)

TypeinterventionalSponsorRutgers, The State University of New JerseyRan2000 to 2016Enrolled2,502ConditionsAtherosclerosis, Stroke, Carotid Stenosis, Cerebral InfarctionArmsCarotid Endarterectomy (CEA), Carotid Artery Stenting (CAS)
NCT00190398 phase3completednot on this map

Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2000 to 2009Enrolled900ConditionsTransient Ischemic Attack, Carotid Stenosis, AtherosclerosisArmsCarotid angioplasty and stenting with cerebral protection
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
  2. Observational
  3. Article
  4. Article
  5. The Impact of Sex and Gender on Stroke.Circulation research · 2022
    Review
  6. Review
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 at 11 institutions in 7 countries.

Virginia J HowardDepartment of Epidemiology (V.J.H.), School of Public Health, University of Alabama at Birmingham.
Ale AlgraDepartment of Neurology and Neurosurgery, Brain Center Rudolf Magnus and Julius Center for Health Sciences and Primary Care (A.A.), and Julius Centre for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, the Netherlands.
George HowardDepartment of Biostatistics (G.H.), School of Public Health, University of Alabama at Birmingham.
Leo H BonatiDepartment of Brain Repair and Rehabilitation, Stroke Research Centre, University College of London Queen Square Institute of Neurology, University College London, United Kingdom (L.H.B., M.M.B.).
Gert J de BorstDepartment of Vascular Surgery (G.J.d.B.), and Julius Centre for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, the Netherlands.
Richard BulbuliaClinical Trial Service Unit and Epidemiological Studies Unit (R.B.), Nuffield Department of Population Health, University of Oxford, United Kingdom.
David CalvetDepartment of Neurology, Hopital Sainte-Anne, Universite Paris-Descartes, DHU Neurovasc Sorbonne Paris Cite, INSERM U894, France (D.C., J.-L.M.).
Hans-Henning EcksteinDepartment of Vascular and Endovascular Surgery/Vascular Center, Klinikum rechts der Isar der Technischen Universitat Munchen, Munich, Germany (H.-H.E.).
Gustav FraedrichDepartment of Vascular Surgery, Medical University of Innsbruck, Austria (G.F.).
Jacoba P GrevingDepartment of Epidemiology (J.P.G.), and Julius Centre for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, the Netherlands.
Alison HallidayNuffield Department of Surgical Sciences, John Radcliffe Hospital, Oxford, United Kingdom (A.H.).
Jeroen HendrikseDepartment of Radiology, University Medical Center Utrecht, the Netherlands (J.H.).
Olav JansenDepartment of Radiology and Neuroradiology, UKSH Campus Kiel, Germany (O.J.).
Martin M BrownDepartment of Brain Repair and Rehabilitation, Stroke Research Centre, University College of London Queen Square Institute of Neurology, University College London, United Kingdom (L.H.B., M.M.B.).
Jean-Louis MasDepartment of Neurology, Hopital Sainte-Anne, Universite Paris-Descartes, DHU Neurovasc Sorbonne Paris Cite, INSERM U894, France (D.C., J.-L.M.).
Peter A RinglebDepartment of Neurology, University of Heidelberg Medical School, Germany (P.A.R.).
Thomas G BrottDepartment of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.).
Carotid Stenosis Trialists’ Collaboration
University Medical Center Utrecht · NLDélégation Paris 5 · FRQueen Mary University of London · GBUniversity of Alabama at Birmingham · USHeidelberg University · DEInnsbruck Medical University · ATJohn Radcliffe Hospital · GBMayo Clinic in Florida · USTUM Klinikum · DEUniversity Hospital Schleswig-Holstein · DEUniversity of Oxford · GB

Funding

Carotid Revascularization Endarterectomy vs Stenting TrialR01NS038384 · NINDS · UNIV OF MED/DENT OF NJ-NJ MEDICAL SCHOOL · PI BROTT, THOMAS G · 1999 to 2010
$40.7M
Carotid Revascularization Endarterectomy vs. Stenting Trial: Long Term Follow-upU01NS038384 · NINDS · UNIV OF MED/DENT OF NJ-NJ MEDICAL SCHOOL · PI BROTT, THOMAS G, SHEFFET, ALICE J · 2011 to 2016
$15.4M
Department of HealthMedical Research CouncilNINDS NIH HHS R01 NS038384NINDS NIH HHS U01 NS038384
6 · The paper itself

Abstract

background and purposeCREST (Carotid Revascularization Endarterectomy Versus Stenting Trial) reported a higher periprocedural risk for any stroke, death, or myocardial infarction for women randomized to carotid artery stenting (CAS) compared with women randomized to carotid endarterectomy (CEA). No difference in risk by treatment was detected for women relative to men in the 4-year primary outcome. We aimed to conduct a pooled analysis among symptomatic patients in large randomized trials to provide more precise estimates of sex differences in the CAS-to-CEA risk for any stroke or death during the 120-day periprocedural period and ipsilateral stroke thereafter.

methodsData from the Carotid Stenosis Trialists' Collaboration included outcomes from symptomatic patients in EVA-3S (Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis), SPACE (Stent-Protected Angioplasty Versus Carotid Endarterectomy in Symptomatic Patients), ICSS (International Carotid Stenting Study), and CREST. The primary outcome was any stroke or death within 120 days after randomization and ipsilateral stroke thereafter. Event rates and relative risks were estimated using Poisson regression; effect modification by sex was assessed with a sex-by-treatment-by-trial interaction term, with significant interaction defined a priori as

resultsOver a median 2.7 years of follow-up, 433 outcomes occurred in 3317 men and 1437 women. The CAS-to-CEA relative risk of the primary outcome was significantly lower for women compared with men in 1 trial, nominally lower in another, and nominally higher in the other two. The sex-by-treatment-by-trial interaction term was significant (

conclusionsThere were significant differences between trials in the magnitude of sex differences in treatment effect (CAS-to-CEA relative risk), indicating pooling data from these trials to estimate sex differences might not be valid. Whether sex is acting as an effect modifier of the CAS-to-CEA treatment effect in symptomatic patients remains uncertain. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00190398 (EVA-3S) and NCT00004732 (CREST). URL: https://www.isrctn.com; Unique identifier: ISRCTN57874028 (SPACE) and ISRCTN25337470 (ICSS).

Indexed as

Sex CharacteristicsTreatment OutcomeAdultAgedAged, 80 and overAngioplastyCarotid StenosisEndarterectomy, CarotidFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicStentscarotid stenosisendarterectomysex characteristicsstentswomen

Identifiers

PMID33493046
PMCPMC9136999
OpenAlexW3125350586

What OpenQuestion holds

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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.