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Safety of Stenting vs. Endarterectomy for Symptomatic Carotid Stenosis
Two trials cast doubt on the safety of carotid stenting, but a final verdict awaits results of ongoing investigations.
Interest is growing in carotid artery stenting (CAS) for symptomatic patients with carotid stenosis. Two recent studies addressed whether CAS is as safe as carotid endarterectomy (CEA) in these patients.
The publicly funded, multicenter, randomized EVA-3S trial was designed to assess the noninferiority of CAS to CEA in patients with symptomatic carotid stenosis 
60% and average surgical risk. The trial was stopped early, after enrolling 527 patients, due to a clearly higher 30-day incidence of any stroke or death with CAS than with CEA (9.6% vs. 3.9%). This difference persisted at 6 months (11.7% vs. 6.1%).
In the partly industry-funded, multicenter SPACE trial, 1200 patients with symptomatic moderate and severe carotid stenosis (70% by ECST criteria [Lancet 1998; 351:1379] or 50% by NASCET criteria [Stroke 1999; 30:1751]) were randomized to undergo CAS or CEA. The 30-day incidence of ipsilateral stroke or death was 6.84% with CAS and 6.34% with CEA, and statistical analysis failed to demonstrate the noninferiority of CAS. Six-month follow-up data are not yet published.
Comment: The EVA-3S trial definitely raises concerns about the safety and generalizability of CAS, but the study had several flaws. Remarkably, the technical requirements for the physicians performing CAS were far less stringent than for CEA. Indeed, the 30-day incidence of stroke or death in the CEA group was one of the lowest ever in a published trial of symptomatic carotid disease (3.9%, vs. 6.5% in NASCET and 6.8% in ECST). Conversely, the 30-day rate for any stroke or death with CAS was one of the highest in trials to date (9.6%, vs. 2.1% in symptomatic patients in the SAPPHIRE trial [N Engl J Med 2004; 351:1493] and 7.7% in the SPACE trial). The use of distal-protection devices was optional when EVA-3S was started, and several different stents and protection devices were used. Dual antiplatelet therapy was recommended, but not required, and most patients did not undergo predilatation angioplasty prior to stenting. All of these factors may have contributed to the unexpectedly high complication rate with CAS.
In the SPACE trial, CAS fared better than in EVA-3S, but it still underperformed relative to CEA and failed to meet the threshold for noninferiority. Again, the degree of technical expertise required to perform CAS was suboptimal, and only 27% of the CAS group were treated with an embolic protection device. Finally, the trial would have had to enroll more than 2500 patients to adequately test its hypothesis with 80% statistical power.
Thus, the equivalence of the periprocedural risks of CAS versus CEA in symptomatic carotid stenosis remains unknown. Let’s hope that other trials, such as the ongoing NIH-funded studies CREST (Carotid Revascularization Endarterectomy vs. Stent Trial) and ICSS (International Carotid Stenting Study), provide more definite answers.
— Raul G. Nogueira, MD
Dr. Nogueira is Assistant in Neurology and Radiology, Massachusetts General Hospital, and Instructor in Neurology, Harvard Medical School, Boston.
Published in Journal Watch Neurology February 6, 2007
Citation(s):
Mas J-L et al for the EVA-3S Investigators. 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)
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.
- Medline abstract (Free)