Journal article
Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): the final results of a randomised trial
The Lancet (British edition), Vol.383(9914), pp.333-341
01/25/2014
DOI: 10.1016/S0140-6736(13)62038-3
PMCID: PMC3971471
PMID: 24168957
Abstract
Early results of the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis trial showed that, by 30 days, 33 (14·7%) of 224 patients in the stenting group and 13 (5·8%) of 227 patients in the medical group had died or had a stroke (percentages are product limit estimates), but provided insufficient data to establish whether stenting offered any longer-term benefit. Here we report the long-term outcome of patients in this trial. Methods: We randomly assigned (1:1, stratified by centre with randomly permuted block sizes) 451 patients with recent transient ischaemic attack or stroke related to 70–99% stenosis of a major intracranial artery to aggressive medical management (antiplatelet therapy, intensive management of vascular risk factors, and a lifestyle-modification programme) or aggressive medical management plus stenting with the Wingspan stent. The primary endpoint was any of the following: stroke or death within 30 days after enrolment, ischaemic stroke in the territory of the qualifying artery beyond 30 days of enrolment, or stroke or death within 30 days after a revascularisation procedure of the qualifying lesion during follow-up. Primary endpoint analysis of between-group differences with log-rank test was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT 00576693. Findings: During a median follow-up of 32·4 months, 34 (15%) of 227 patients in the medical group and 52 (23%) of 224 patients in the stenting group had a primary endpoint event. The cumulative probability of the primary endpoints was smaller in the medical group versus the percutaneous transluminal angioplasty and stenting (PTAS) group (p=0·0252). Beyond 30 days, 21 (10%) of 210 patients in the medical group and 19 (10%) of 191 patients in the stenting group had a primary endpoint. The absolute differences in the primary endpoint rates between the two groups were 7·1% at year 1 (95% CI 0·2 to 13·8%; p=0·0428), 6·5% at year 2 (–0·5 to 13·5%; p=0·07) and 9·0% at year 3 (1·5 to 16·5%; p=0·0193). The occurrence of the following adverse events was higher in the PTAS group than in the medical group: any stroke (59 [26%] of 224 patients vs 42 [19%] of 227 patients; p=0·0468) and major haemorrhage (29 [13%]of 224 patients vs 10 [4%] of 227 patients; p=0·0009). Interpretation: The early benefit of aggressive medical management over stenting with the Wingspan stent for high-risk patients with intracranial stenosis persists over extended follow-up. Our findings lend support to the use of aggressive medical management rather than PTAS with the Wingspan system in high-risk patients with atherosclerotic intracranial arterial stenosis.
Details
- Title: Subtitle
- Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): the final results of a randomised trial
- Creators
- Colin P Derdeyn - Mallinckrodt Institute of Radiology and the Departments of Neurology and Neurosurgery, Washington University School of Medicine, St Louis, MO, USA. Electronic address: derdeync@wustl.eduMarc I Chimowitz - Department of Neurosciences, Medical University of South Carolina, Charleston, SC, USAMichael J Lynn - Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public, Health, Atlanta, GA, USADavid Fiorella - Department of Neurosurgery, State University of New York, Stony Brook, NY, USATanya N Turan - Department of Neurosciences, Medical University of South Carolina, Charleston, SC, USAL Scott Janis - National Institute of Neurological Disorders and Stroke, National Institute of Health, Bethesda, MD, USAJean Montgomery - Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public, Health, Atlanta, GA, USAAzhar Nizam - Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public, Health, Atlanta, GA, USABethany F Lane - Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public, Health, Atlanta, GA, USAHelmi L Lutsep - Department of Neurology, Oregon Health and Science University, Portland, OR, USAStanley L Barnwell - Department of Neurological Surgery and the Dotter Interventional Institute, Oregon Health Sciences University, Portland, OR, USAMichael F Waters - Departments of Neurology and Neuroscience, University of Florida, Gainesville, FL, USABrian L Hoh - Department of Neurosurgery, University of Florida, Gainesville, FL, USAJ Maurice Hourihane - Dent Neurological Institute, Buffalo, NY, USAElad I Levy - Department of Neurosurgery, University of Buffalo, NY, USAAndrei V Alexandrov - Department of Neurology, University of Alabama, Birmingham, AL, USAMark R Harrigan - Department of Neurosurgery, University of Alabama, Birmingham, AL, USADavid Chiu - Department of Neurology, Houston Methodist Hospital, Houston, TX, USARichard P Klucznik - Department of Radiology, Houston Methodist Hospital, Houston, TX, USAJoni M Clark - Department of Neurology, Barrow Neurological Institute, Phoenix, AZ, USACameron G McDougall - Department of Neurosurgery, Barrow Neurological Institute, Phoenix, AZ, USAMark D Johnson - Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USAG Lee Pride Jr - Departments of Radiology and Neurosurgery, University of Texas Southwestern Medical Center, Dallas, TX, USAJohn R Lynch - Department of Neurology, Medical College of Wisconsin, Milwaukee, WI, USAOsama O Zaidat - Departments of Neurology, Radiology, and Neurosurgery, Medical College of Wisconsin, Milwaukee, WIZoran Rumboldt - Department of Radiology, Medical University of South Carolina, Charleston, SC, USAHarry J Cloft - Department of Radiology, Mayo Clinic, Rochester, MN, USA
- Resource Type
- Journal article
- Publication Details
- The Lancet (British edition), Vol.383(9914), pp.333-341
- Publisher
- England
- DOI
- 10.1016/S0140-6736(13)62038-3
- PMID
- 24168957
- PMCID
- PMC3971471
- ISSN
- 0140-6736
- eISSN
- 1474-547X
- Grant note
- UL1 RR024131 / NCRR NIH HHS U01 NS058728 / NINDS NIH HHS UL1RR029890 / NCRR NIH HHS UL1RR029882 / NCRR NIH HHS UL1 RR029890 / NCRR NIH HHS K23 NS069668 / NINDS NIH HHS UL1RR029889 / NCRR NIH HHS UL1RR024131 / NCRR NIH HHS UL1 RR029882 / NCRR NIH HHS TL1 RR029889 / NCRR NIH HHS
- Language
- English
- Date published
- 01/25/2014
- Academic Unit
- Neurology; Radiology; Iowa Neuroscience Institute; Neurosurgery
- Record Identifier
- 9984020766402771
Metrics
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