Helmi L Lutsep1, Stanley L Barnwell2, Darren T Larsen2, Michael J Lynn2, Mindy Hong2, Tanya N Turan2, Colin P Derdeyn2, David Fiorella2, L Scott Janis2, Marc I Chimowitz2. 1. From the Department of Neurology (H.L.L., D.T.L.), and Department of Neurological Surgery and Dotter Interventional Institute (S.L.B.), Oregon Health and Science University, Portland; Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, GA (M.J.L., M.H.); Department of Neurology, Medical University of South Carolina, Charleston (T.N.T., M.I.C.); Department of Radiology, Washington University School of Medicine, St. Louis, MO (C.P.D.); Department of Neurological Surgery, State University of New York, Stony Brook, NY (D.F.); and National Institutes of Health, Bethesda, MD (L.S.J.). lutseph@ohsu.edu. 2. From the Department of Neurology (H.L.L., D.T.L.), and Department of Neurological Surgery and Dotter Interventional Institute (S.L.B.), Oregon Health and Science University, Portland; Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, GA (M.J.L., M.H.); Department of Neurology, Medical University of South Carolina, Charleston (T.N.T., M.I.C.); Department of Radiology, Washington University School of Medicine, St. Louis, MO (C.P.D.); Department of Neurological Surgery, State University of New York, Stony Brook, NY (D.F.); and National Institutes of Health, Bethesda, MD (L.S.J.).
Abstract
BACKGROUND AND PURPOSE: Stenting has been used as a rescue therapy in patients with intracranial arterial stenosis and a transient ischemic attack or stroke when on antithrombotic therapy (AT). We determined whether the stenting versus aggressive medical therapy for intracranial arterial stenosis (SAMMPRIS) trial supported this approach by comparing the treatments within subgroups of patients whose qualifying event (QE) occurred on versus off of AT. METHODS: The primary outcome, 30-day stroke and death and later strokes in the territory of the qualifying artery, was compared between (1) percutaneous transluminal angioplasty and stenting plus aggressive medical therapy (PTAS) versus aggressive medical management therapy alone (AMM) for patients whose QE occurred on versus off AT and between (2) patients whose QE occurred on versus off AT separately for the treatment groups. RESULTS: Among the 284/451 (63%) patients who had their QE on AT, the 2-year primary end point rates were 15.6% for those randomized to AMM (n=140) and 21.6% for PTAS (n=144; P=0.043, log-rank test). In the 167 patients not on AT, the 2-year primary end point rates were 11.6% for AMM (n=87) and 18.8% for PTAS (n=80; P=0.31, log-rank test). Within both treatment groups, there was no difference in the time to the primary end point between patients who were on or off AT (AMM, P=0.96; PTAS, P=0.52; log-rank test). CONCLUSIONS: SAMMPRIS results indicate that the benefit of AMM over PTAS is similar in patients on versus off AT at the QE and that failure of AT is not a predictor of increased risk of a primary end point. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00576693.
RCT Entities:
BACKGROUND AND PURPOSE: Stenting has been used as a rescue therapy in patients with intracranial arterial stenosis and a transient ischemic attack or stroke when on antithrombotic therapy (AT). We determined whether the stenting versus aggressive medical therapy for intracranial arterial stenosis (SAMMPRIS) trial supported this approach by comparing the treatments within subgroups of patients whose qualifying event (QE) occurred on versus off of AT. METHODS: The primary outcome, 30-day stroke and death and later strokes in the territory of the qualifying artery, was compared between (1) percutaneous transluminal angioplasty and stenting plus aggressive medical therapy (PTAS) versus aggressive medical management therapy alone (AMM) for patients whose QE occurred on versus off AT and between (2) patients whose QE occurred on versus off AT separately for the treatment groups. RESULTS: Among the 284/451 (63%) patients who had their QE on AT, the 2-year primary end point rates were 15.6% for those randomized to AMM (n=140) and 21.6% for PTAS (n=144; P=0.043, log-rank test). In the 167 patients not on AT, the 2-year primary end point rates were 11.6% for AMM (n=87) and 18.8% for PTAS (n=80; P=0.31, log-rank test). Within both treatment groups, there was no difference in the time to the primary end point between patients who were on or off AT (AMM, P=0.96; PTAS, P=0.52; log-rank test). CONCLUSIONS: SAMMPRIS results indicate that the benefit of AMM over PTAS is similar in patients on versus off AT at the QE and that failure of AT is not a predictor of increased risk of a primary end point. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00576693.
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