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Carotid Artery Stenting May Be Equivalent to Endarterectomy in High-Risk Patients

Protected stenting is gaining ground in this patient population, but this study's findings remain controversial.

In a vendor-sponsored trial under the acronym SAPPHIRE, researchers compared endarterectomy with carotid stenting using an embolic-protection device in high-risk patients. They enrolled 747 patients who had specific comorbidities (such as clinically important cardiac disease or recurrent stenosis after a previous endarterectomy), 50% or greater symptomatic stenosis, or 80% or greater asymptomatic stenosis. Clinical equipoise (for undergoing stenting or surgery), required for randomization, was present for 334 patients; the remaining 413 patients were assigned to surgery or stenting. Participants underwent neurologic assessments daily during hospitalization, then at 30 days, at 6 months, and annually. Primary endpoints were (1) a composite of death, stroke, or myocardial infarction (MI) at 30 days, and (2) ipsilateral stroke or death from 31 days to 1 year postprocedure.

Among randomized patients, the cumulative risk for stroke, death, or MI at 30 days was 39% lower with stenting than with endarterectomy; the combined risk for the two primary endpoints at 1 year was 7.9% lower with stenting. The authors concluded that stenting with embolic protection is not inferior to endarterectomy (P=0.004). These data narrowly missed the mark for statistical superiority of stenting (P=0.053). Fewer stented patients required reoperation than did those who underwent endarterectomy.

Comment: These findings demonstrate the efficacy of distal embolic protection during carotid stenting in a high-risk population. Yet stenting -- and this study -- remain controversial, as an accompanying editorial emphasizes. Of the enrolled patients, 55% were excluded from randomization as poor surgical candidates, a number that appears high and may introduce bias. More than 20% of patients were being treated for restenosis following prior endarterectomy, likely favoring endovascular techniques. Including MI in the composite endpoint obscures the effects of less frequent strokes and deaths, which were primary endpoints in the large endarterectomy trials (Stroke 1991; 22:711 and JAMA 1995; 273:1421). SAPPHIRE was not powered to evaluate stroke and death alone. Carotid stenting may become the de facto treatment for carotid stenosis, but additional well-constructed trials, now underway, are necessary to settle this ongoing debate.

— Philip M. Meyers, MD

Dr. Meyers is Clinical Director, Neuroendovascular Service, New York Presybterian Hospitals -- Columbia University, Neurological Institute of New York, New York City.

Published in Journal Watch Neurology November 5, 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.

• Original article (Subscription may be required)
• Medline abstract (Free)

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

• Original article (Subscription may be required)
• Medline abstract (Free)