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Previous Volume 358:1572-1579 April 10, 2008 Number 15 Next

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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 [ClinicalTrials.gov] .)

Source Information

From the University of Michigan School of Medicine, Ann Arbor (H.S.G.); Piedmont Cardiovascular Institute, Atlanta (J.S.Y.); University of Nebraska Medical Center, Omaha (P.F.); Miami Cardiac and Vascular Institute, Miami (B.T.K.); Prairie Heart Institute, St. John's Hospital, Springfield, IL (G.J.M.); Milwaukee Heart Institute, Milwaukee (T.K.B.); Mid-Ohio Cardiovascular Consultants, Columbus (G.A.); Saint Luke's Hospital, Houston (N.E.S.); Cordis, Warren, NJ (H.W., S.A.C.); University of Pennsylvania School of Medicine, Philadelphia (S.A.C.); and Harvard Clinical Research Institute (J.M.M., D.E.C.) and Beth Israel Deaconess Medical Center and Harvard Medical School (D.E.C.) — all in Boston.

Address reprint requests to Dr. Cutlip at the Harvard Clinical Research Institute, Harvard Medical School, 930 Commonwealth Ave., Boston, MA 02215, or at don.cutlip{at}hcri.harvard.edu.

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