Evidence map›Paper›PMID 26251251›Full record

SynthesisStroke2015

Do Patient Characteristics Explain the Differences in Outcome Between Medically Treated Patients in SAMMPRIS and WASID?

Seemant Chaturvedi, Tanya N Turan, Michael J Lynn, Colin P Derdeyn, David Fiorella, L Scott Janis, Marc I Chimowitz, SAMMPRIS Trial Investigators

Registry-linked trialOpen access · greenAbstract readComparative StudyMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Stroke, 2015. 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 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
2.2field-weighted citation impact, top 12% 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.

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

19 citing papers in PubMed, 37 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Lipid Levels and Short-Term Risk of Recurrent Brain Infarcts in Symptomatic Intracranial Stenosis.Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association · 2022
    Article
  10. Prevalence, prognosis, and treatment of atherosclerotic intracranial stenosis in Caucasians.International journal of stroke : official journal of the International Stroke Society · 2021
    Article
  11. Article
  12. Is the future of symptomatic intracranial atherosclerotic stenosis management promising?Journal of neurology, neurosurgery, and psychiatry · 2020 · on this map
    Article
  13. Article
  14. Antithrombotic Management of Ischemic Stroke.Current treatment options in cardiovascular medicine · 2019
    Review
  15. Article
  16. Review
  17. Review
  18. Management of Symptomatic Intracranial Stenosis.Current cardiology reports · 2016
    Review
  19. Article
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

8 authors at 5 institutions in 1 country.

Seemant ChaturvediFrom the Department of Neurology, University of Miami, Miami, FL (S.C.); Department of Neurosciences, Medical University of South Carolina, Charleston, SC (T.N.T., M.I.C.); Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, GA (M.J.L.); Mallinckrodt Institute of Radiology and the Departments of Neurology and Neurosurgery, Washington University School of Medicine, St Louis MO (C.P.D.); Department of Neurosurgery, State University of New York, Stony Brook, NY (D.F.); and National Institute of Neurological Disorders and Stroke, National Institute of Health, Bethesda, MD (L.S.J.). SChaturvedi@med.miami.edu.
Tanya N TuranFrom the Department of Neurology, University of Miami, Miami, FL (S.C.); Department of Neurosciences, Medical University of South Carolina, Charleston, SC (T.N.T., M.I.C.); Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, GA (M.J.L.); Mallinckrodt Institute of Radiology and the Departments of Neurology and Neurosurgery, Washington University School of Medicine, St Louis MO (C.P.D.); Department of Neurosurgery, State University of New York, Stony Brook, NY (D.F.); and National Institute of Neurological Disorders and Stroke, National Institute of Health, Bethesda, MD (L.S.J.).
Michael J LynnFrom the Department of Neurology, University of Miami, Miami, FL (S.C.); Department of Neurosciences, Medical University of South Carolina, Charleston, SC (T.N.T., M.I.C.); Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, GA (M.J.L.); Mallinckrodt Institute of Radiology and the Departments of Neurology and Neurosurgery, Washington University School of Medicine, St Louis MO (C.P.D.); Department of Neurosurgery, State University of New York, Stony Brook, NY (D.F.); and National Institute of Neurological Disorders and Stroke, National Institute of Health, Bethesda, MD (L.S.J.).
Colin P DerdeynFrom the Department of Neurology, University of Miami, Miami, FL (S.C.); Department of Neurosciences, Medical University of South Carolina, Charleston, SC (T.N.T., M.I.C.); Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, GA (M.J.L.); Mallinckrodt Institute of Radiology and the Departments of Neurology and Neurosurgery, Washington University School of Medicine, St Louis MO (C.P.D.); Department of Neurosurgery, State University of New York, Stony Brook, NY (D.F.); and National Institute of Neurological Disorders and Stroke, National Institute of Health, Bethesda, MD (L.S.J.).
David FiorellaFrom the Department of Neurology, University of Miami, Miami, FL (S.C.); Department of Neurosciences, Medical University of South Carolina, Charleston, SC (T.N.T., M.I.C.); Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, GA (M.J.L.); Mallinckrodt Institute of Radiology and the Departments of Neurology and Neurosurgery, Washington University School of Medicine, St Louis MO (C.P.D.); Department of Neurosurgery, State University of New York, Stony Brook, NY (D.F.); and National Institute of Neurological Disorders and Stroke, National Institute of Health, Bethesda, MD (L.S.J.).
L Scott JanisFrom the Department of Neurology, University of Miami, Miami, FL (S.C.); Department of Neurosciences, Medical University of South Carolina, Charleston, SC (T.N.T., M.I.C.); Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, GA (M.J.L.); Mallinckrodt Institute of Radiology and the Departments of Neurology and Neurosurgery, Washington University School of Medicine, St Louis MO (C.P.D.); Department of Neurosurgery, State University of New York, Stony Brook, NY (D.F.); and National Institute of Neurological Disorders and Stroke, National Institute of Health, Bethesda, MD (L.S.J.).
Marc I ChimowitzFrom the Department of Neurology, University of Miami, Miami, FL (S.C.); Department of Neurosciences, Medical University of South Carolina, Charleston, SC (T.N.T., M.I.C.); Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, GA (M.J.L.); Mallinckrodt Institute of Radiology and the Departments of Neurology and Neurosurgery, Washington University School of Medicine, St Louis MO (C.P.D.); Department of Neurosurgery, State University of New York, Stony Brook, NY (D.F.); and National Institute of Neurological Disorders and Stroke, National Institute of Health, Bethesda, MD (L.S.J.).
SAMMPRIS Trial Investigators
University of Miami · USEmory University · USLynn University · USMedical University of South Carolina · USState University of New York · US

Funding

UCSF CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTEUL1RR024131 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JOHNSTON, S. CLAIBORNE · 2006 to 2011
$111.2M
Using social networks to map and evaluate team science across CTSA hubsUL1TR001427 · NCATS · UNIVERSITY OF FLORIDA · PI MITCHELL, DUANE A. · 2015 to 2024
$37.2M
SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing . . .U01NS058728 · NINDS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI CHIMOWITZ, MARC IVOR · 2008 to 2011
$20.0M
P30-Core Grant for Vision Research Core CP30EY006360 · NEI · EMORY UNIVERSITY · PI NICKERSON, JOHN M · 1986 to 2025
$15.3M
UF CLINICAL AND TRANSLATIONAL SCIENCE AWARDUL1RR029890 · NCRR · UNIVERSITY OF FLORIDA · PI NELSON, DAVID R · 2009 to 2011
$14.4M
SOUTH CAROLINA CLINICAL & TRANSLATIONAL RESEARCH INSTITUTE (SCTR)UL1RR029882 · NCRR · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2009 to 2011
$10.1M
WARFARIN VS ASPIRIN FOR INTRACRANIAL ARTERIAL STENOSISR01NS036643 · NINDS · EMORY UNIVERSITY · PI CHIMOWITZ, MARC IVOR · 1998 to 2002
$9.1M
Coordinating Center for Infant Aphakia Treatment Study (IATS)U10EY013287 · NEI · EMORY UNIVERSITY · PI LONG, QI · 2004 to 2014
$5.8M
The Role of Cerebral Hemodynamics in Moya Moya DiseaseR01NS051631 · NINDS · WASHINGTON UNIVERSITY · PI DERDEYN, COLIN PIETER · 2006 to 2010
$1.6M
Coordinating Center for Infant Aphakia Treatment Study (IATS)UG1EY013287 · NEI · EMORY UNIVERSITY · PI NIZAM, AZHAR · 2015 to 2018
$917k
Characterization of Intracranial Atherosclerotic Stenosis Using HR MRIK23NS069668 · NINDS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI TURAN, TANYA N · 2011 to 2015
$903k
Intracranial Stents for Arterial StenosisK24NS050307 · NINDS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI CHIMOWITZ, MARC IVOR · 2005 to 2009
$697k
NCATS NIH HHS UL1 TR001427NCRR NIH HHS TL1 RR029889NCRR NIH HHS UL1 RR024131NCRR NIH HHS UL1RR024131NCRR NIH HHS UL1 RR029882NCRR NIH HHS UL1RR029882NCRR NIH HHS UL1RR029889NCRR NIH HHS UL1 RR029890NCRR NIH HHS UL1RR029890NEI NIH HHS P30 EY006360NEI NIH HHS U10 EY013287NEI NIH HHS UG1 EY013287NINDS NIH HHS K23 NS069668NINDS NIH HHS K24 NS050307NINDS NIH HHS R01 NS036643NINDS NIH HHS R01 NS051631NINDS NIH HHS R01 NS051688NINDS NIH HHS U01 NS058728
6 · The paper itself

Abstract

background and purposeThe Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) medical group had a much lower primary end point rate than predicted from the preceding Warfarin Aspirin Symptomatic Intracranial Disease (WASID) trial. This result has been attributed to the aggressive medical therapy used in SAMMPRIS, but an alternative hypothesis is that SAMMPRIS patients were at lower risk. We undertook analyses to evaluate these competing hypotheses.

methodsUsing proportional hazards regression, we compared the SAMMPRIS primary end point between SAMMPRIS medical patients and WASID patients meeting the same qualifying criteria adjusted for confounding baseline characteristics.

resultsThe unadjusted comparison of the SAMMPRIS primary end point showed a significantly higher risk for WASID patients (P=0.009, logrank test) with 12 month Kaplan-Meier estimates of 21.9% in WASID and 12.6% in SAMMPRIS and hazard ratio 1.9 (95% confidence interval =1.2-3.0). The analyses identified the following confounding factors that varied between the studies and that conferred a higher risk: lack of statin use at enrollment (hazard ratio =1.8, 95% confidence interval =1.1-2.9, P=0.027) that was more prevalent among WASID patients (39% versus 14%, P<0.0001) and prior infarcts in the territory of the symptomatic vessel (hazard ratio =1.8, 95% confidence interval =1.1-2.9, P=0.023) that was more prevalent among SAMMPRIS patients (34% versus 22%, P=0.015).The hazard ratio for WASID versus SAMMPRIS adjusted for these 2 characteristics was 1.9 (95% confidence interval =1.1-3.2).

conclusionsAfter adjustment for confounding baseline characteristics, WASID patients had an almost 2-fold higher risk of the SAMMPRIS primary end point, which supports the hypothesis that the lower rate of the primary end point in the medical arm of SAMMPRIS compared with WASID patients was as a result of the aggressive medical management used in SAMMPRIS. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT00576693.

Indexed as

AgedClinical Trials as TopicFemaleHumansIschemic Attack, TransientKaplan-Meier EstimateMaleMiddle AgedOutcome Assessment, Health CareStrokeatherosclerosisdyslipidemiaintracranial atherosclerosisstrokewarfarin

Identifiers

PMID26251251
PMCPMC4550543
OpenAlexW2157659503

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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.