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Protected Carotid Stenting vs. Endarterectomy in High-Risk Patients

Carotid stenting with embolic protection compared favorably with endarterectomy and was associated with fewer complications.

In the manufacturer-funded, multicenter SAPPHIRE trial, researchers randomized 334 patients with severe carotid-artery stenosis to percutaneous placement of a self-expanding nitinol stent with an embolic-protection device or to surgical endarterectomy. All subjects had at least one characteristic that qualified them as high-risk for surgery (e.g., age >80, clinically significant cardiac disease); carotid stenosis was at least 50% in symptomatic patients and at least 80% in asymptomatic patients. The lead author invented the distal-protection device used in the trial, and other authors are consultants or employees of the stent manufacturer.

Incidence of the primary endpoint (death, stroke, or MI within 30 days, or ipsilateral stroke or death within 1 year) was 12% in the stent group and 20% in the surgery group (P=0.004 for the noninferiority of stenting). Excluding MIs rendered this difference nonsignificant, as did including only symptomatic patients in the analysis. Cranial nerve palsy occurred in no stent recipients and 5% of the surgery group, and target-vessel revascularization (TVR) was required in 0.6% and 4.3%, respectively -- both between-groups differences were significant.

Comment: In this randomized trial of high-risk patients, carotid stenting with embolic protection compared favorably with endarterectomy and was associated with fewer complications, particularly periprocedural MI, cranial nerve palsy, and subsequent TVR. An editorialist cautions that stenting might have gained an advantage in this trial from the exclusion criteria and from the high proportion of patients (about 22%) who had experienced recurrent carotid stenosis after a previous endarterectomy. Despite these caveats, carotid stenting appears to be a reasonable alternative to surgery for many patients.

— Howard C. Herrmann, MD

Published in Journal Watch Cardiology November 19, 2004

Citation(s):

Yadav JS et al. for the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy Investigators. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med 2004 Oct 7; 351:1493-501.

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• Medline abstract (Free)

Cambria RP. Stenting for carotid-artery stenosis. N Engl J Med 2004 Oct 7; 351:1565-7.

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• Medline abstract (Free)