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Abstract

Why is this study important?
Atherosclerotic stenosis of the major intracranial arteries is one of the most common causes of stroke worldwide. It causes 30% to 50% of strokes in Asians and 8% to 10% of strokes in North American Caucasians. Intracranial atherosclerosis preferentially affects Asians, Hispanics, Far East Asians and Blacks.
Patients with a recent transient ischaemic attack (TIA) or stroke and severe stenosis (70 to 99% of the diameter of a major intracranial artery) are at particularly high risk for recurrent stroke in the territory of the stenotic artery (approximately 23% at 1 year).
There are two treatment strategies that have emerged for the management of high-risk patients: aggressive medical therapy (combination anti-platelet therapy and intensive management of risk factors) and percutaneous Tran\\\'s luminal angioplasty and stenting (PTAS).
There is uncertainty regarding the safety and efficacy of aggressive medical management alone as compared with aggressive medical management plus PTAS with the use of the Wingspan stent system. For this reason this trial (SAMMPRIS) was the first trial started in November 2008 to compare the two treatment options in high risk patients with intracranial arterial stenosis.
Who were the participants?
SAMMPRIS was an investigator-initiated, randomized, double-blind, multi-center clinical trial funded by the National Institute of Neurological Disorders and Stroke and conducted at 50 sites in the United States. Population of interest included both inpatients and outpatients at the participating sites. Patients were recruited if they had a TIA or non-disabling stroke within 30 days before enrollment, attributed to angiographically verified stenosis of 70 to 99% of the diameter of a major intracranial artery.
A total of 451 patients underwent randomization, 227 were assigned to the medical-management group and 224 to the PTAS group. There were no significant differences between the two groups with respect to any of the baseline characteristics of the patients.
What was the intervention?
Medical management was identical in the two groups and consisted of aspirin, at a dose of 325 mg per day; clopidogrel, at a dose of 75 mg per day for 90 days after enrollment; management of the primary risk factors (elevated systolic blood pressure and elevated low-density lipoprotein [LDL]cholesterol levels); and management of secondary risk factors (diabetes, elevated non-high-density lipoprotein [non-HDL] cholesterol levels, smoking, excess weight, and insufficient exercise) with the help of a lifestyle modification programme. The target for systolic blood pressure of less than 140 mm Hg (