Outcome in patients previously on antithrombotic therapy in the SAMMPRIS trial: subgroup analysis

Helmi L Lutsep; Stanley L Barnwell; Darren T Larsen; Michael J Lynn; Mindy Hong; Tanya N Turan; Colin P Derdeyn; David Fiorella; L Scott Janis; Marc I Chimowitz

doi:10.1161/STROKEAHA.114.007752

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Outcome in patients previously on antithrombotic therapy in the SAMMPRIS trial: subgroup analysis

Journal article

Open access

Peer reviewed

Outcome in patients previously on antithrombotic therapy in the SAMMPRIS trial: subgroup analysis

Helmi L Lutsep, Stanley L Barnwell, Darren T Larsen, Michael J Lynn, Mindy Hong, Tanya N Turan, Colin P Derdeyn, David Fiorella, L Scott Janis and Marc I Chimowitz

Stroke (1970), Vol.46(3), pp.775-779

03/2015

DOI: 10.1161/STROKEAHA.114.007752

PMCID: PMC4342339

PMID: 25593135

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https://doi.org/10.1161/STROKEAHA.114.007752View

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Abstract

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. 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. 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). 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. http://www.clinicaltrials.gov. Unique identifier: NCT00576693.

Intracranial Arteriosclerosis - drug therapy

Data Interpretation, Statistical

Ischemic Attack, Transient - drug therapy

Humans

Middle Aged

Male

Treatment Outcome

Angioplasty - methods

Ischemic Attack, Transient - surgery

Fibrinolytic Agents - adverse effects

Drug Therapy, Combination - adverse effects

Constriction, Pathologic - drug therapy

Constriction, Pathologic - surgery

Intracranial Arteriosclerosis - surgery

Fibrinolytic Agents - therapeutic use

Female

Aged

Stents

Details

Title: Subtitle: Outcome in patients previously on antithrombotic therapy in the SAMMPRIS trial: subgroup analysis
Creators: Helmi L Lutsep - 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
Stanley L Barnwell - 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.)
Darren T Larsen - 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.)
Michael J Lynn - 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.)
Mindy Hong - 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.)
Tanya N Turan - 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.)
Colin P Derdeyn - 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.)
David Fiorella - 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.)
L Scott Janis - 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.)
Marc I Chimowitz - 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.)
Resource Type: Journal article
Publication Details: Stroke (1970), Vol.46(3), pp.775-779
Publisher: United States
DOI: 10.1161/STROKEAHA.114.007752
PMID: 25593135
PMCID: PMC4342339
ISSN: 0039-2499
eISSN: 1524-4628
Grant note: U10 EY013287 / NEI NIH HHS U01 NS058728 / NINDS NIH HHS K23 NS069668 / NINDS NIH HHS P30 EY006360 / NEI NIH HHS UG1 EY013287 / NEI NIH HHS
Language: English
Date published: 03/2015
Academic Unit: Neurology; Radiology; Iowa Neuroscience Institute; Neurosurgery
Record Identifier: 9984020612802771

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