Design of the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis trial

• Type of Material: Article
• Authors: Marc I. Chimowitz, Medical University of South Carolina; Michael Lynn, Emory University; Tanya N. Turan, Medical University of South Carolina; David Fiorella, Stony Brook University; Bethany F. Lane, Emory University; Scott Janis, National Institute of Neurological Disorders and Stroke; Colin P. Derdeyn, Washington University
• Language: English
• Date: 2011-07-01
• Publisher: Elsevier: 12 months
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2011 by National Stroke Association.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.jstrokecerebrovasdis.2011.05.001
• Title of Journal or Parent Work: Journal of Stroke and Cerebrovascular Diseases
• ISSN: 1052-3057
• Volume: 20
• Issue: 4
• Start Page: 357
• End Page: 368
• Grant/Funding Information: Stryker Neurovascular (formerly Boston Scientific Neurovascular) provides study devices and supplemental funding for third party device distribution, site monitoring and study auditing.; This research is also supported by the Investigator-Sponsored Study Program of AstraZeneca that donates rosuvastatin (Crestor) to study patients.; This study was funded by a research grant (U01 NS058728) from the US Public Health Service National Institute of Neurological Disorders and Stroke (NINDS).
• Keywords: Treatment Outcome; Risk Reduction Behavior; Research Design; Hypolipidemic Agents; Platelet Aggregation Inhibitors; Risk Assessment; Constriction, Pathologic; Drug Therapy, Combination; Aspirin; United States; Sample Size; Humans; Ticlopidine; Antihypertensive Agents; Time Factors; Cerebral Arterial Diseases; Secondary Prevention; Arterial Occlusive Diseases; Ischemic Attack, Transient; Risk Factors; Angioplasty; Stroke; Stents; Clopidogrel
• Research Categories: Biology, Neuroscience; Biology, Biostatistics; Health Sciences, Medicine and Surgery

Abstract

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 lifetsyle 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.