Editorials |
From the Department of Medicine (Neurology), Duke Stroke Center, Center for Clinical Health Policy Research, Duke University; and Durham Department of Veterans Affairs Medical Center, Durham, NC.
Correspondence to Larry B. Goldstein, MD, Box 3651, Duke University Medical Center, Durham, NC 27710. E-mail golds004@mc.duke.edu
Key Words: Editorials carotid arteries stents angioplasty stroke prevention complications
An extract of the first 250 words of the full text is provided, because this article has no abstract. |
Endarterectomy is recommended in current clinical guidelines for selected patients with a significant symptomatic or asymptomatic extracranial carotid artery stenosis, provided that the operation can be performed with acceptable safety.1–3 These recommendations are based on the results of several controlled trials in which those randomized to have the operation had better clinical outcomes compared with those who did not, on a background of what at the time was considered to constitute best medical therapy. The advent of angioplasty/stenting offers the promise of a less invasive means of directly treating carotid artery steno-occlusive disease compared with endarterectomy. Unlike surgical procedures, however, pharmaceuticals, biologicals, and devices are subject to regulatory approval in the United States by the Food and Drug Administration. Placement of a carotid artery stent system was first approved by the Food and Drug Administration in 2004 for the treatment of patients deemed "at high risk for adverse events from carotid endarterectomy who require carotid revascularization [who have] neurological symptoms and
50% stenosis of the common or internal carotid artery by ultrasound or angiogram, or in patients without neurological symptoms and
80% stenosis of the common or internal carotid artery by ultrasound or angiogram" (http://www.fda.gov/cdrh/pdf4/p040012a.pdf).
Article see p 159
Registries were developed to help assess the safety of stent systems as used in larger populations, in part to help identify risks that might not have been apparent based on the smaller numbers of subjects included in the randomized trial that compared stenting with endarterectomy in patients at high risk of
Related Article
Circ Cardiovasc Interv 2009 2: 159-166.
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