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When the FDA approved several devices for carotid stenting, it mandated postapproval surveillance to gather additional data on effectiveness and safety. In this report, researchers present findings from a registry of 3500 high-risk patients (mean age, 73) who have received Acculink carotid stents with distal protection devices since 2004. Carotid stenosis was asymptomatic in 86% of patients.
Patients were examined by neurologists before stenting, and at 1 and 30 days after. At 30 days, mortality was 1.8%, and major and minor stroke rates were 2.0% and 2.9%, respectively. The rate of the composite of stroke, death, or myocardial infarction was 6.3%. Major strokes occurred in 4.6% of patients with symptomatic carotid stenosis and 1.6% of those…