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SAMMPRIS

"Stenting vs. Aggressive Medical Therapy for Intracranial Arterial Stenosis".The New England Journal of Medicine. 2011. 365:11-23.PubMed•Full text•PDF

Clinical Question

Does the addition of percutaneous transluminal angioplasty and stenting (PTAS) with the Wingspan stent system to aggressive medical therapy improve outcomes in patients with intracranial arterial stenosis who have had a recent transient ischemic attack or stroke?

Bottom Line

In patients with intracranial arterial stenosis, aggressive medical management alone reduces the risk of stroke or death compared to PTAS plus aggressive medical management, as the risk of early stroke post-PTAS is high.

Major Points

Guidelines

Design

Multicenter, randomized, controlled trial comparing aggressive medical management alone versus aggressive medical management plus PTAS in patients with intracranial arterial stenosis.

Population

Inclusion Criteria:
- Recent transient ischemic attack or stroke attributed to stenosis of 70 to 99% of the diameter of a major intracranial artery.

Exclusion Criteria:
- Non-atherosclerotic cause of stroke, contraindications to study medications, life expectancy less than 3 years due to nonvascular diseases, and other significant conditions detracting from the suitability for study procedures.

Baseline Characteristics
- No significant differences in baseline characteristics between medical management and PTAS groups.

Interventions

- Aggressive medical management included aspirin (325 mg/day), clopidogrel (75 mg/day for 90 days), and intensive management of risk factors (targeting systolic blood pressure <140 mm Hg and LDL cholesterol <70 mg/dL).
- PTAS using the Wingspan stent system.

Outcomes

Primary Outcomes:
- Combined endpoint of stroke or death within 30 days after enrollment, stroke or death within 30 days after any revascularization procedure for the qualifying lesion, or stroke in the territory beyond 30 days.
Secondary Outcomes:
- Any stroke, major hemorrhage, or death; death or any stroke; rates of targeted risk factor control.

Criticisms

- Long-term outcomes were not available due to early termination of the trial, and study results do not apply to PTAS using other devices.

Funding

Sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) with supplemental funding and equipment from Stryker Neurovascular and drug donations from AstraZeneca. Other industry partners noted with involvement in trial operation processes.