Design of the stenting and aggressive medical management for preventing recurrent stroke in intracranial stenosis trial. J Stroke Cerebrovasc Dis 2011;20(4):357-68
Date
07/07/2011Pubmed ID
21729789Pubmed Central ID
PMC3506385DOI
10.1016/j.jstrokecerebrovasdis.2011.05.001Scopus ID
2-s2.0-79959936182 (requires institutional sign-in at Scopus site) 113 CitationsAbstract
BACKGROUND: Patients with recent transient ischemic attack (TIA) or stroke caused by 70% to 99% stenosis of a major intracranial artery are at high risk of recurrent stroke on usual medical management, suggesting the need for alternative therapies for this disease.
METHODS: The Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis trial is an ongoing, randomized, multicenter, 2-arm trial that will determine whether intracranial angioplasty and stenting adds benefit to aggressive medical management alone for preventing the primary endpoint (any stroke or death within 30 days after enrollment or after any revascularization procedure of the qualifying lesion during follow-up, or stroke in the territory of the symptomatic intracranial artery beyond 30 days) during a mean follow-up of 2 years in patients with recent TIA or stroke caused by 70% to 99% stenosis of a major intracranial artery. Aggressive medical management in both arms consists of aspirin 325 mg per day, clopidogrel 75 mg per day for 90 days after enrollment, intensive risk factor management primarily targeting systolic blood pressure <140 mm Hg (<130 mm Hg in diabetics) and low density cholesterol <70 mg/dL, and a lifestyle modification program. The sample size required to detect a 35% reduction in the rate of the primary endpoint from angioplasty and stenting based on the log-rank test with an alpha of 0.05, 80% power, and adjusting for a 2% loss to follow-up and 5% crossover from the medical to the stenting arm is 382 patients per group.
RESULTS: Enrollment began in November 2008 and 451 patients have been enrolled as of March 31, 2011.
CONCLUSIONS: This is the first randomized stroke prevention trial to compare angioplasty and stenting with medical therapy in patients with intracranial arterial stenosis and to incorporate intensive management of multiple risk factors and a lifestyle modification program in the study design. Hopefully, the results of the trial will lead to more effective therapy for this high-risk disease.
Author List
Chimowitz MI, Lynn MJ, Turan TN, Fiorella D, Lane BF, Janis S, Derdeyn CP, SAMMPRIS InvestigatorsMESH terms used to index this publication - Major topics in bold
AngioplastyAntihypertensive Agents
Arterial Occlusive Diseases
Aspirin
Cerebral Arterial Diseases
Constriction, Pathologic
Drug Therapy, Combination
Humans
Hypolipidemic Agents
Ischemic Attack, Transient
Platelet Aggregation Inhibitors
Research Design
Risk Assessment
Risk Factors
Risk Reduction Behavior
Sample Size
Secondary Prevention
Stents
Stroke
Ticlopidine
Time Factors
Treatment Outcome
United States
