Reporting Standards for Carotid Artery Angioplasty and Stent Placement

C erebrovascular disease is the third leading cause of death in the United States. Approximately 750 000 people have a stroke annually, costing an estimated 45 billion in treatment and lost productivity. Carotid occlusive disease is responsible for 25% of these strokes. Large population-based studies indicate that the prevalence of carotid stenosis is approximately 0. 5% after age 60 and increases to 10% in persons older than age 80 years. The majority of cases are asymptomatic. 6 -8 Surgical carotid endarterectomy is currently the accepted standard of treatment for revascularization of extracranial carotid occlusive disease. 9 This has been validated by multiple, randomized, controlled trials that have demonstrated its efficacy over best medical therapy. However, in the past several years, carotid artery stenting has emerged as a potential therapeutic alternative to carotid endarterectomy for the treatment of atherosclerotic carotid artery disease. The future status of this endovascular approach will be determined by randomized trials directly comparing carotid artery stenting to endarterectomy, as well as by the potential for further innovation and improvement in endovascular devices, techniques, and safety. Comparisons of carotid stenting and endarterectomy are difficult because of differences in patient selection, the use of case series rather than randomized controlled trials for stenting, differences in definitions of outcomes and complications, and observer bias. The suggested reporting standards for carotid endarterectomy have not been uniformly followed up for surgical trials and not used in trials of carotid stenting. 10 It is the purpose of this document to standardize reporting of carotid stent trials and recommend trial designs so that carotid stenting and endarterectomy may be fairly compared. This document is a consensus statement of the Technology Assessment Committees of the American Society of Interventional and Therapeutic Neuroradiology and the Society of Interventional Radiology.