Helmi L Lutsep1, Michael J Lynn2, George A Cotsonis2, Colin P Derdeyn2, Tanya N Turan2, David Fiorella2, L Scott Janis2, Bethany F Lane2, Jean Montgomery2, Marc I Chimowitz2. 1. From the Department of Neurology, Oregon Health and Science University, Portland (H.L.L.); Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA (M.J.L., G.A.C., B.F.L., J.M.); Department of Radiology, Washington University School of Medicine, St. Louis, MO (C.P.D.); Department of Neurology, Medical University of South Carolina, Charleston (T.N.T., M.I.C.); Department of Neurological Surgery, State University of New York, Old Westbury (D.F.); and National Institutes of Health, Bethesda, MD (L.S.J.). lutseph@ohsu.edu. 2. From the Department of Neurology, Oregon Health and Science University, Portland (H.L.L.); Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA (M.J.L., G.A.C., B.F.L., J.M.); Department of Radiology, Washington University School of Medicine, St. Louis, MO (C.P.D.); Department of Neurology, Medical University of South Carolina, Charleston (T.N.T., M.I.C.); Department of Neurological Surgery, State University of New York, Old Westbury (D.F.); and National Institutes of Health, Bethesda, MD (L.S.J.).
Abstract
BACKGROUND AND PURPOSE: Although the Stenting Versus Aggressive Medical Therapy for Intracranial Arterial Stenosis (SAMMPRIS) trial showed that medical therapy alone was superior to stenting plus medical therapy for preventing recurrent strokes in patients with symptomatic intracranial stenosis, we determined whether SAMMPRIS supported the use of stenting in any subpopulations of patients with symptomatic intracranial arterial stenosis. METHODS: The primary outcome, 30-day stroke and death and later strokes in the territory of the qualifying artery, was compared in those with and without baseline factors in the 2 treatment arms, percutaneous transluminal angioplasty and stenting (PTAS) plus aggressive medical therapy versus aggressive medical therapy alone. Baseline factors included sex, age, race, diabetes mellitus, hypertension, lipid disorder, smoking status, type of qualifying event, qualifying event hypoperfusion symptoms, use of antithrombotic or proton pump inhibitor at baseline, days to enrollment, old infarcts in the same territory, percent stenosis, other artery stenosis, and location of the symptomatic artery. RESULTS: A total of 451 patients were enrolled, 227 randomized to aggressive medical therapy and 224 to PTAS. Of all variables evaluated, the observed 2-year event rates were higher with PTAS than with aggressive medical therapy in the vast majority and the interaction with treatment was not statistically significant for any of the factors. CONCLUSIONS: The SAMMPRIS results do not provide evidence to support the use of PTAS using the Wingspan stent system compared with medical treatment in any examined subpopulation of patients with symptomatic intracranial stenosis, including those with qualifying event hypoperfusion symptoms. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00576693.
RCT Entities:
BACKGROUND AND PURPOSE: Although the Stenting Versus Aggressive Medical Therapy for Intracranial Arterial Stenosis (SAMMPRIS) trial showed that medical therapy alone was superior to stenting plus medical therapy for preventing recurrent strokes in patients with symptomatic intracranial stenosis, we determined whether SAMMPRIS supported the use of stenting in any subpopulations of patients with symptomatic intracranial arterial stenosis. METHODS: The primary outcome, 30-day stroke and death and later strokes in the territory of the qualifying artery, was compared in those with and without baseline factors in the 2 treatment arms, percutaneous transluminal angioplasty and stenting (PTAS) plus aggressive medical therapy versus aggressive medical therapy alone. Baseline factors included sex, age, race, diabetes mellitus, hypertension, lipid disorder, smoking status, type of qualifying event, qualifying event hypoperfusion symptoms, use of antithrombotic or proton pump inhibitor at baseline, days to enrollment, old infarcts in the same territory, percent stenosis, other artery stenosis, and location of the symptomatic artery. RESULTS: A total of 451 patients were enrolled, 227 randomized to aggressive medical therapy and 224 to PTAS. Of all variables evaluated, the observed 2-year event rates were higher with PTAS than with aggressive medical therapy in the vast majority and the interaction with treatment was not statistically significant for any of the factors. CONCLUSIONS: The SAMMPRIS results do not provide evidence to support the use of PTAS using the Wingspan stent system compared with medical treatment in any examined subpopulation of patients with symptomatic intracranial stenosis, including those with qualifying event hypoperfusion symptoms. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00576693.
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