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Previous Volume 351:1493-1501 October 7, 2004 Number 15 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Cambria, R. P. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Carotid endarterectomy is more effective than medical management in the prevention of stroke in patients with severe symptomatic or asymptomatic atherosclerotic carotid-artery stenosis. Stenting with the use of an emboli-protection device is a less invasive revascularization strategy than endarterectomy in carotid-artery disease.

Methods We conducted a randomized trial comparing carotid-artery stenting with the use of an emboli-protection device to endarterectomy in 334 patients with coexisting conditions that potentially increased the risk posed by endarterectomy and who had either a symptomatic carotid-artery stenosis of at least 50 percent of the luminal diameter or an asymptomatic stenosis of at least 80 percent. The primary end point of the study was the cumulative incidence of a major cardiovascular event at 1 year — a composite of death, stroke, or myocardial infarction within 30 days after the intervention or death or ipsilateral stroke between 31 days and 1 year. The study was designed to test the hypothesis that the less invasive strategy, stenting, was not inferior to endarterectomy.

Results The primary end point occurred in 20 patients randomly assigned to undergo carotid-artery stenting with an emboli-protection device (cumulative incidence, 12.2 percent) and in 32 patients randomly assigned to undergo endarterectomy (cumulative incidence, 20.1 percent; absolute difference, –7.9 percentage points; 95 percent confidence interval, –16.4 to 0.7 percentage points; P=0.004 for noninferiority, and P=0.053 for superiority). At one year, carotid revascularization was repeated in fewer patients who had received stents than in those who had undergone endarterectomy (cumulative incidence, 0.6 percent vs. 4.3 percent; P=0.04).

Conclusions Among patients with severe carotid-artery stenosis and coexisting conditions, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy.

Source Information

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.

Full Text of this Article

Related Letters:

Carotid-Artery Stenting versus Endarterectomy
Friedman H. S., Eliasziw M., Barnett H. J.M., Killestein J., Tonarelli S. B., Hart R. G., Yadav J. S., Ouriel K., Fayad P.
Extract | Full Text | PDF  
N Engl J Med 2005; 352:624-627, Feb 10, 2005. Correspondence

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