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(Stroke. 2002;33:2519.)
© 2002 American Heart Association, Inc.

Controversies in Stroke

Angioplasty and Stenting Should Be Performed Only in the Setting of a Clinical Trial

Thomas G. Brott, MD

From the Mayo Clinic, Jacksonville, Florida.

Correspondence to Thomas G. Brott, MD, Mayo Clinic, 4500 San Pablo Rd, Jacksonville, FL 32224. E-mail brott.thomas@mayo.edu

Key Words: carotid endarterectomy • clinical trials • outcome • stents

An extract of the first 250 words of the full text is provided, because this article has no abstract.

Dr Roubin cites exciting observational data supporting carotid artery stenting as treatment for focal carotid artery disease. Unfortunately, observational studies cannot substitute for randomized trials.¹ The design is not experimental. The treatment for each patient is chosen by the interventionalist, and so selection bias cannot be avoided. Assessment of outcomes is vulnerable to investigator ascertainment bias and in some cases conflict of interest. Full reporting cannot be ensured, nor can publication bias be avoided. Comparison to historical controls is not valid because the competing medical and surgical treatments have advanced.

For surgical therapy, randomized trials have shown that absolute risk reduction may be high as 5% per year for symptomatic patients with stenosis 70%,^2,3 approximately 1% per year for symptomatic patients with stenosis 50% to 69%,³ and up to 1% per year in asymptomatic patients with stenosis 60%, when surgical results are optimal.⁴ Benefits for asymptomatic women following CEA have not been established, and CEA has not been compared with medical treatments as currently recommended (eg, antihypertensive therapy for blood pressure 135 mm Hg systolic, 85 mm Hg diastolic; lipid-lowering therapy for diet-resistant LDL >100 mg/dL; alternative antiplatelet therapy for aspirin failure).⁵

For carotid stenting, safety and efficacy (and durability) as first-choice treatment have not been established for low-risk patients. For such patients, those who would have been eligible for NASCET or ACAS, carotid stenting must be considered experimental. CEA is the standard of care. Accordingly, carotid stenting should be done in the context of a clinical trial protocol, patient . . . [Full Text of this Article]

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