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The results of the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial were published recently in the New England Journal of Medicine.1 The trial was a randomized controlled trial which was sponsored by the National Institutes of Health (clinicaltrials.gov number, NCT0057693). Entrance into the trial required the presence of a symptomatic 70–99% stenosis of a large vessel intracranial artery (internal carotid, M1 segment of middle cerebral artery, vertebral or basilar). Patients had to be randomized within 30 days of their qualifying event. Patients were randomized to receive either maximum medical therapy alone or maximum medical therapy in combination with angioplasty and stenting of the target lesion using the Gateway/Wingspan system (Boston Scientific/Stryker, Fremont, CA, USA). The maximum medical therapy regimen was defined as: aspirin 325 mg/ day; clopidogrel 75 mg/day for 90 days after enrolment; management of primary risk factors (elevated systolic blood pressure and elevated low density lipoprotein cholesterol levels) and management of secondary risk factors (diabetes, elevated non-high density lipoprotein cholesterol levels, smoking, excess weight and insufficient exercise). The study provided enrolled patients aspirin, clopidogrel, one drug from each major class of antihypertensive agents and rosuvastatin. In the stenting arm, the Gateway/Wingspan system was provided to the patient. Lifestyle modification was facilitated by a study provided ‘lifestyle coach’.
The study results demonstrated a higher than expected 30 day stroke rate in the stent plus medical therapy arm (14.7%) and a lower than expected 30 day stroke rate in the medical therapy alone arm (5.8%). The estimated 1 year stroke rate for the …
Competing interests None.
Provenance and peer review Commissioned; internally peer reviewed.