title: Outcome in patients previously on antithrombotic therapy in the SAMMPRIS trial: subgroup analysis.
abstract: OBJECTIVE
  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.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifier: NCT00576693.
authors.affiliation: 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.
authors.forename: Helmi L
authors.initials: HL
authors.lastname: Lutsep
authors.affiliation: 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.).
authors.forename: Stanley L
authors.initials: SL
authors.lastname: Barnwell
authors.affiliation: 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.).
authors.forename: Darren T
authors.initials: DT
authors.lastname: Larsen
authors.affiliation: 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.).
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Lynn
authors.affiliation: 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.).
authors.forename: Mindy
authors.initials: M
authors.lastname: Hong
authors.affiliation: 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.).
authors.forename: Tanya N
authors.initials: TN
authors.lastname: Turan
authors.affiliation: 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.).
authors.forename: Colin P
authors.initials: CP
authors.lastname: Derdeyn
authors.affiliation: 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.).
authors.forename: David
authors.initials: D
authors.lastname: Fiorella
authors.affiliation: 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.).
authors.forename: L Scott
authors.initials: LS
authors.lastname: Janis
authors.affiliation: 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.).
authors.forename: Marc I
authors.initials: MI
authors.lastname: Chimowitz
mesh_terms: D000368:Aged; D017130:Angioplasty / Q000379:methods; D003251:Constriction, Pathologic / Q000188:drug therapy / Q000601:surgery; D003627:Data Interpretation, Statistical; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D002537:Intracranial Arteriosclerosis / Q000188:drug therapy* / Q000601:surgery; D002546:Ischemic Attack, Transient / Q000188:drug therapy / Q000601:surgery; D008297:Male; D008875:Middle Aged; D015607:Stents; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents
keywords: antiplatelet agents; intracranial arteriosclerosis; stroke