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Original Article
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Volume 358:1572-1579 April 10, 2008 Number 15
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Long-Term Results of Carotid Stenting versus Endarterectomy in High-Risk Patients
Hitinder S. Gurm, M.D., Jay S. Yadav, M.D., Pierre Fayad, M.D., Barry T. Katzen, M.D., Gregory J. Mishkel, M.D., Tanvir K. Bajwa, M.D., Gary Ansel, M.D., Neil E. Strickman, M.D., Hong Wang, M.D., M.P.H., Sidney A. Cohen, M.D., Ph.D., Joseph M. Massaro, Ph.D., Donald E. Cutlip, M.D., for the SAPPHIRE Investigators

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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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