More Ambiguous Results on Carotid Stenting vs. Endarterectomy

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More Ambiguous Results on Carotid Stenting vs. Endarterectomy

Thirty-day results from the SPACE trial failed to demonstrate the noninferiority of stenting.

In patients with moderate-to-severe symptomatic carotid stenosis and recent ischemic events, guidelines consistently recommend carotid endarterectomy (CEA), but carotid angioplasty and stenting (CAS) is an increasingly popular alternative. However, a systematic review of five small randomized trials did not show a significant difference in outcomes between endarterectomy and stenting, and another recent trial, "EVA-3S," was stopped early when an interim analysis showed significantly higher 30-day risk with stenting (Journal Watch Oct 18 2006).

In the "SPACE" trial, European researchers undertook a separate effort to establish whether CAS is noninferior to CEA. They randomized 1183 patients — all with onset of neurologic or ocular symptoms within the past 180 days and ipsilateral carotid stenosis of at least 70% on ultrasound — to receive either CAS or CEA within 14 days. Rates of the primary outcome — ipsilateral stroke or death from any cause during the 30 days after treatment — were not significantly different between the groups (6.8% for CAS vs. 6.3% for CEA). According to a predefined statistical analysis, the trial failed to show that CAS was noninferior to CEA. Nonsignificant trends favored CEA on six of eight secondary endpoints.

Comment: These results are ambiguous. An editorialist predicts that interventionists will emphasize the similar outcomes in the two groups, while surgeons will stress the failure to prove the noninferiority of stenting and the trends favoring endarterectomy. The authors will eventually report longer-term outcomes from the "SPACE" trial; larger studies such as the "CREST" trial and meta-analyses may also help shed light on this controversy.

— Bruce Soloway, MD

Published in Journal Watch General Medicine October 24, 2006

Citation(s):

The SPACE Collaborative Group. 30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: A randomised non-inferiority trial. Lancet 2006 Oct 7; 368:1239-47.