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Outcome in patients previously on antithrombotic therapy in the SAMMPRIS trial: subgroup analysis
Helmi L Lutsep1, Stanley L Barnwell2, Darren T Larsen2
1From 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.
Insights
Stenting (PTAS) did not improve outcomes compared to aggressive medical management (AMM) for intracranial arterial stenosis, regardless of whether the qualifying event occurred on or off antithrombotic therapy (AT). AT failure did not predict a higher risk of stroke or death.
Area of Science:
- Neurology
- Interventional Cardiology
- Vascular Medicine
Background:
- Intracranial arterial stenosis (IAS) poses a significant risk for transient ischemic attack (TIA) and stroke.
- Stenting has been considered as a rescue therapy for IAS, particularly in patients experiencing a qualifying event (QE) while on antithrombotic therapy (AT).
- The Stenting versus Aggressive Medical Therapy for Intracranial Arterial Stenosis (SAMMPRIS) trial provides crucial data on IAS management.
Purpose of the Study:
- To evaluate the efficacy of percutaneous transluminal angioplasty and stenting plus aggressive medical therapy (PTAS) versus aggressive medical management (AMM) alone in patients with IAS.
- To compare treatment outcomes based on whether the qualifying event (QE) occurred while patients were on or off antithrombotic therapy (AT).
- To determine if AT failure is a predictor of adverse outcomes in IAS patients undergoing stenting or medical management.
Main Methods:
- The SAMMPRIS trial compared PTAS plus AMM against AMM alone for patients with IAS and a QE.
- Primary outcome: 30-day stroke and death, plus later strokes in the territory of the qualifying artery.
- Subgroup analysis: Patients were categorized based on QE occurrence on versus off AT, and compared within and between treatment groups.
Main Results:
- In patients whose QE occurred on AT (n=284), 2-year primary endpoint rates were 15.6% for AMM and 21.6% for PTAS (P=0.043).
- In patients whose QE occurred off AT (n=167), 2-year primary endpoint rates were 11.6% for AMM and 18.8% for PTAS (P=0.31).
- No significant difference in the time to primary endpoint was observed between patients on or off AT within either the AMM or PTAS groups.
Conclusions:
- The benefit of AMM over PTAS for IAS is consistent, irrespective of whether the QE occurred on or off AT.
- Failure of antithrombotic therapy (AT) at the time of QE is not a predictor of increased risk for primary endpoint events.
- Aggressive medical management alone appears to be the preferred strategy for IAS, offering similar outcomes to stenting regardless of prior AT use.
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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