BACKGROUND: Carotid endarterectomy is more effective than medical management i n the prevention of stroke in patients with severe symptomatic or asymptomatic a therosclerotic carotid artery ste.osis. ste.ting with the...
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BACKGROUND: Carotid endarterectomy is more effective than medical management i n the prevention of stroke in patients with severe symptomatic or asymptomatic a therosclerotic carotid artery ste.osis. ste.ting with the use of an emboli pro tection device is a less invasive revascularization strategy than endarterectomy in carotid artery disease. METhODS: We conducted a randomized trial comparing carotid artery ste.ting with the use of an em boli protection device to endar terectomy in 334 patients with coexisting conditions that potentially increased the risk posed by endarterectomy and who had either a symptomatic carotid arter y ste.osis of at least 50 percent of the luminal diameter or an asymptomatic ste.nosis of at least 80 percent. The primary end point of the study was the cumulat ive 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, ste.ting, was not inferior to e ndarterectomy. RESULTS: The primary end point occurred in 20 patients randomly a ssigned to undergo carotid artery ste.ting with an emboli protection device (c umulative incidence, 12.2 percent) and in 32 patients randomly assigned to under go endarterectomy (cumulative incidence, 20.1 percent; absolute difference, -7. 9 percentage points; 95 percent confidence interval, -16.4 to 0.7 percentage po ints; P=0.004 for noninferiority, and P=0.053 for superiority). At one year, car otid revascularization was repeated in fewer patients who had received ste.ts th an in those who had undergone endarterectomy (cumulative incidence, 0.6 percent vs. 4.3 percent; P=0.04). CONCLUSIONS: Among patients with severe carotid arter y ste.osis and coexisting conditions, carotid ste.ting with the use of an emboli protection device is not inferior to carotid endarterectomy.
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