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Carotid Stenting vs. Endarterectomy — More Confusion Than Clarity

The EVA-3S trial was stopped early, after an interim analysis showed that 30-day risk for stroke or death was significantly higher with stenting.

In a previously published randomized U.S. trial ("SAPPHIRE"), patients with carotid stenosis and high perioperative risk underwent either carotid endarterectomy (CEA) or carotid-artery stenting with embolic protection. One-month and 1-year outcomes with stenting were at least as good as outcomes with CEA (Journal Watch Oct 29 2004).

Now, we have results from a multicenter, randomized French trial ("EVA-3S"), in which researchers enrolled patients with recent nondisabling stroke or transient ischemic attack (TIA) plus carotid stenosis 60%. Patients underwent either CEA or stenting, with embolic protection devices deployed in 92% of stented patients. The investigators used five different stents and seven different protection devices during the trial. The study was stopped after 527 patients were enrolled, because an interim analysis showed that 30-day risk for stroke or death was significantly higher with stenting than with CEA (9.6% vs. 3.9%). An excess of strokes on the day of the procedure in stented patients accounted for this difference.

Comment: Why do these results differ dramatically from those of the SAPPHIRE trial? An editorialist outlines many possible reasons, including differences in enrollment criteria, differences in experience among the interventional physicians, differences in periprocedural antiplatelet therapy, and the multiplicity of devices used in EVA-3S (vs. use of a single device in SAPPHIRE). The discordant results of these trials suggest that additional studies are needed; ideally, answers will be provided by "CREST", an ongoing North American trial with a projected enrollment of 2500 patients.

— Allan S. Brett, MD

Published in Journal Watch General Medicine October 18, 2006

Citation(s):

Mas J-L et al. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med 2006 Oct 19; 355:1660-71.

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

Furlan AJ. Carotid-artery stenting — Case open or closed? N Engl J Med 2006 Oct 19; 355:1726-9.

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