Protected Carotid-Artery Stenting versus Endarterectomy in High-Risk Patients
Jay S. Yadav, M.D., Mark H. Wholey, M.D., Richard E. Kuntz, M.D., M.Sc., Pierre Fayad, M.D., Barry T. Katzen, M.D., Gregory J. Mishkel, M.D., Tanvir K. Bajwa, M.D., Patrick Whitlow, M.D., Neil E. Strickman, M.D., Michael R. Jaff, D.O., Jeffrey J. Popma, M.D., David B. Snead, Ph.D., Donald E. Cutlip, M.D., Brian G. Firth, M.D., Ph.D., Kenneth Ouriel, M.D., for the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy Investigators
Methods We conducted a randomized trial comparing carotid-arterystenting with the use of an emboli-protection device to endarterectomyin 334 patients with coexisting conditions that potentiallyincreased the risk posed by endarterectomy and who had eithera symptomatic carotid-artery stenosis of at least 50 percentof the luminal diameter or an asymptomatic stenosis of at least80 percent. The primary end point of the study was the cumulativeincidence of a major cardiovascular event at 1 year a composite of death, stroke, or myocardial infarction within30 days after the intervention or death or ipsilateral strokebetween 31 days and 1 year. The study was designed to test thehypothesis that the less invasive strategy, stenting, was notinferior to endarterectomy.
From the Cleveland Clinic Foundation, Cleveland (J.S.Y., P.W., K.O.); Pittsburgh Vascular Institute, Pittsburgh (M.H.W.); the Department of Cardiology (R.E.K.) and the Angiographic Core Laboratory (J.J.P.), Brigham and Women's Hospital, Boston; Harvard Medical School, Boston (R.E.K., D.E.C.); University of Nebraska, Omaha (P.F.); Miami Vascular Institute, Miami (B.T.K.); Prairie Cardiovascular Institute, Springfield, Ill. (G.J.M.); St. Luke's Medical Center, Milwaukee (T.K.B.); Texas Heart Institute, Houston (N.E.S.); Vascular Ultrasound Core Laboratory, Morristown, N.J. (M.R.J.); Cordis, Warren, N.J. (D.B.S., B.G.F.); and Beth Israel Deaconess Medical Center, Boston (D.E.C.).
Address reprint requests to Dr. Yadav at Cardiovascular Medicine, Desk F25, Cleveland Clinic Foundation, 9500 Euclid Ave., Cleveland, OH 44195, or at yadavj{at}ccf.org.
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