Long-term results of carotid stenting versus endarterectomy in high-risk patients

Hitinder S. Gurm, Jay S. Yadav, Pierre B Fayad, Barry T. Katzen, Gregory J. Mishkel, Tanvir K. Bajwa, Gary Ansel, Neil E. Strickman, Hong Wang, Sidney A. Cohen, Joseph M. Massaro, Donald E. Cutlip

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Abstract

BACKGROUND: We previously reported that, in a randomized trial, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy for the treatment of carotid artery disease at 30 days and at 1 year. We now report the 3-year results. METHODS: The trial evaluated carotid artery stenting with the use of an emboli-protection device as compared with endarterectomy in 334 patients at increased risk for complications from endarterectomy who had either a symptomatic carotid artery stenosis of at least 50% of the luminal diameter or an asymptomatic stenosis of at least 80%. The prespecified major secondary end point at 3 years was a composite of death, stroke, or myocardial infarction within 30 days after the procedure or death or ipsilateral stroke between 31 days and 1080 days (3 years). RESULTS: At 3 years, data were available for 260 patients (77.8%), including 85.6% of patients in the stenting group and 70.1% of those in the endarterectomy group. The prespecified major secondary end point occurred in 41 patients in the stenting group (cumulative incidence, 24.6%; Kaplan-Meier estimate, 26.2%) and 45 patients in the endarterectomy group (cumulative incidence, 26.9%; Kaplan-Meier estimate, 30.3%) (absolute difference in cumulative incidence for the stenting group, -2.3%; 95% confidence interval, -11.8 to 7.0). There were 15 strokes in each of the two groups, of which 11 in the stenting group and 9 in the endarterectomy group were ipsilateral. CONCLUSIONS: In our trial of patients with severe carotid artery stenosis and increased surgical risk, no significant difference could be shown in long-term outcomes between patients who underwent carotid artery stenting with an emboli-protection device and those who underwent endarterectomy. (ClinicalTrials.gov number, NCT00231270.)

Original languageEnglish (US)
Pages (from-to)1572-1579
Number of pages8
JournalNew England Journal of Medicine
Volume358
Issue number15
DOIs
StatePublished - Apr 10 2008

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ASJC Scopus subject areas

  • Medicine(all)

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Gurm, H. S., Yadav, J. S., Fayad, P. B., Katzen, B. T., Mishkel, G. J., Bajwa, T. K., Ansel, G., Strickman, N. E., Wang, H., Cohen, S. A., Massaro, J. M., & Cutlip, D. E. (2008). Long-term results of carotid stenting versus endarterectomy in high-risk patients. New England Journal of Medicine, 358(15), 1572-1579. https://doi.org/10.1056/NEJMoa0708028