Journal article
Stenting versus Aggressive Medical Therapy for Intracranial Arterial Stenosis
The New England journal of medicine, Vol.365(11), pp.993-1003
2011
DOI: 10.1056/NEJMoa1105335
PMCID: PMC3552515
PMID: 21899409
Abstract
BACKGROUND: Atherosclerotic intracranial arterial stenosis is an important cause of stroke that is increasingly being treated with percutaneous transluminal angioplasty and stenting (PTAS) to prevent recurrent stroke. However, PTAS has not been compared with medical management in a randomized trial. METHODS: We randomly assigned patients who had a recent transient ischemic attack or stroke attributed to stenosis of 70 to 99% of the diameter of a major intracranial artery to aggressive medical management alone or aggressive medical management plus PTAS with the use of the Wingspan stent system. The primary end point was stroke or death within 30 days after enrollment or after a revascularization procedure for the qualifying lesion during the follow-up period or stroke in the territory of the qualifying artery beyond 30 days. RESULTS: Enrollment was stopped after 451 patients underwent randomization, because the 30-day rate of stroke or death was 14.7% in the PTAS group (nonfatal stroke, 12.5%; fatal stroke, 2.2%) and 5.8% in the medical-management group (nonfatal stroke, 5.3%; non–stroke-related death, 0.4%) (P=0.002). Beyond 30 days, stroke in the same territory occurred in 13 patients in each group. Currently, the mean duration of follow-up, which is ongoing, is 11.9 months. The probability of the occurrence of a primary end-point event over time differed significantly between the two treatment groups (P=0.009), with 1-year rates of the primary end point of 20.0% in the PTAS group and 12.2% in the medical-management group. CONCLUSIONS: In patients with intracranial arterial stenosis, aggressive medical management was superior to PTAS with the use of the Wingspan stent system, both because the risk of early stroke after PTAS was high and because the risk of stroke with aggressive medical therapy alone was lower than expected. (Funded by the National Institute of Neurological Disorders and Stroke and others; SAMMPRIS ClinicalTrials.gov number, NCT00576693. opens in new tab.)
Details
- Title: Subtitle
- Stenting versus Aggressive Medical Therapy for Intracranial Arterial Stenosis
- Creators
- Marc I CHIMOWITZ - The authors' affiliations are as follows: the Departments ofNeurosciences, Medical University of South Carolina, Charleston, United StatesMichael J LYNN - Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, United StatesBrian L HOH - Neurosurgery, University of Florida, Gainesville, United StatesJ Maurice Hourihane - Dent Neurological Institute, University of Buffalo, NY, United StatesElad I LEVY - Department of Neurosurgery, University of Buffalo, NY, United StatesAndrei V ALEXANDROV - Departments of Neurology, University of Alabama, Birmingham, United StatesMark R HARRIGAN - Neurosurgery, University of Alabama, Birmingham, United StatesDavid CHIU - Department of Neurology, Methodist Hospital, Houston, United StatesRichard P KLUCZNIK - Department of Radiology, Methodist Hospital, Houston, United StatesJoni M CLARK - Department of Neurology, Barrow Neurological Institute, Phoenix, AZ, United StatesCameron G MCDOUGALL - Department of Neurosurgery, Barrow Neurological Institute, Phoenix, AZ, United StatesMark D JOHNSON - Department of Neurology, University of Texas Southwestern Medical Center, Dallas, United StatesColin P DERDEYN - Mallinckrodt Institute of Radiology and the Departments of Neurology and Neurosurgery, Washington University School of Medicine, St. Louis, United StatesG Lee Pride - Department of Radiology, University of Texas Southwestern Medical Center, Dallas, United StatesMichel T TORBEY - Department of Neurology, Medical College of Wisconsin, Milwaukee, United StatesOsama O ZAIDAT - Department of Neurology, Medical College of Wisconsin, Milwaukee, United StatesZoran RUMBOLDT - Radiology, Medical University of South Carolina, Charleston, United StatesHarry J CLOFT - The authors' affiliations are as follows: the Departments ofNeurosciences, Medical University of South Carolina, Charleston, United StatesTanya N TURAN - The authors' affiliations are as follows: the Departments ofNeurosciences, Medical University of South Carolina, Charleston, United StatesDavid FIORELLA - Department of Neurosurgery, State University of New York, Stony Brook, United StatesBethany F LANE - Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, United StatesL Scott Janis - National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, United StatesHelmi L LUTSEP - Department ofNeurology, Oregon Health Sciences University, Portland, United StatesStanley L BARNWELL - Department of Neurological Surgery and the Dotter Interventional Institute, Oregon Health Sciences University, Portland, United StatesMichael F WATERS - Departments of Neurology and Neuroscience, University of Florida, Gainesville, United States
- Resource Type
- Journal article
- Publication Details
- The New England journal of medicine, Vol.365(11), pp.993-1003
- Publisher
- Massachusetts Medical Society; Waltham, MA
- DOI
- 10.1056/NEJMoa1105335
- PMID
- 21899409
- PMCID
- PMC3552515
- ISSN
- 0028-4793
- eISSN
- 1533-4406
- Language
- English
- Date published
- 2011
- Academic Unit
- Neurology; Radiology; Iowa Neuroscience Institute; Neurosurgery
- Record Identifier
- 9984020500802771
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