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Does the Stenting Versus Aggressive Medical Therapy Trial Support Stenting for Subgroups With Intracranial Stenosis?
Helmi L Lutsep1, Michael J Lynn2, George A Cotsonis2
1From 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.
Insights
The SAMMPRIS trial found aggressive medical therapy superior to stenting plus medical therapy for preventing recurrent strokes in intracranial stenosis. No patient subgroup benefited from stenting, including those with hypoperfusion symptoms.
Area of Science:
- Neurology
- Interventional Cardiology
- Vascular Surgery
Background:
- The Stenting Versus Aggressive Medical Therapy for Intracranial Arterial Stenosis (SAMMPRIS) trial investigated treatments for symptomatic intracranial stenosis.
- Previous findings indicated medical therapy alone was superior to stenting plus medical therapy.
Purpose of the Study:
- To determine if the SAMMPRIS trial supported stenting in specific patient subpopulations with symptomatic intracranial arterial stenosis.
- To analyze if baseline factors modified the treatment effect of stenting versus medical therapy.
Main Methods:
- A total of 451 patients were enrolled, randomized to aggressive medical therapy or percutaneous transluminal angioplasty and stenting (PTAS) plus aggressive medical therapy.
- The primary outcome was 30-day stroke/death and later strokes in the qualifying artery territory.
- Analysis compared event rates based on various baseline factors, including demographics, medical history, and stenosis characteristics.
Main Results:
- Event rates were higher with PTAS compared to aggressive medical therapy alone in most evaluated variables.
- No statistically significant interaction was found between treatment arms and any of the baseline factors examined.
- The 2-year event rates did not favor stenting in any subgroup.
Conclusions:
- The SAMMPRIS trial results do not support the use of PTAS with the Wingspan stent system in any subgroup of patients with symptomatic intracranial stenosis.
- This includes patients experiencing qualifying event hypoperfusion symptoms, where stenting showed no benefit over medical treatment.
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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