"Stenting vs. Aggressive Medical Therapy for Intracranial Arterial Stenosis".The New England Journal of Medicine. 2011. 365:11-23.
Links to original sources: Wiki Journal Post Full Journal Article
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?
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.
Atherosclerotic intracranial arterial stenosis is linked to a high risk of recurrent stroke, and the need for effective treatment is crucial. The Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial compared PTAS with the use of the Wingspan stent system plus aggressive medical treatment against aggressive medical treatment alone. The trial was halted early due to safety concerns over the high rates of stroke or death in the PTAS group. Results demonstrated higher 30-day stroke or death rates in the PTAS group (14.7%) compared with the medical management group (5.8%).
The SAMMPRIS trial results influenced practice by discouraging the use of PTAS with Wingspan in patients with intracranial stenosis. Subsequently, aggressive medical therapy became the recommended foundation of treatment for these patients.
Multicenter, randomized, controlled trial comparing aggressive medical management alone versus aggressive medical management plus PTAS in patients with intracranial arterial stenosis.
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.
- 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.
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.
- Long-term outcomes were not available due to early termination of the trial, and study results do not apply to PTAS using other devices.
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.
Additional reading available at: - The New England Journal of Medicine. 2011;365:11-23. - ClinicalTrials.gov number, NCT00576693.