Protected carotid-artery stenting versus endarterectomy in high-risk patients

Jay S. Yadav, Mark H. Wholey, Richard E. Kuntz, Pierre B Fayad, Barry T. Katzen, Gregory J. Mishkel, Tanvir K. Bajwa, Patrick Whitlow, Neil E. Strickman, Michael R. Jaff, Jeffrey J. Popma, David B. Snead, Donald E. Cutlip, Brian G. Firth, Kenneth Ouriel

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)1493-1501+1586
JournalNew England Journal of Medicine
Volume351
Issue number15
DOIs
StatePublished - Oct 7 2004

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Endarterectomy
Embolic Protection Devices
Carotid Arteries
Carotid Stenosis
Carotid Endarterectomy
Stroke
Incidence
Carotid Artery Diseases
Stents
Pathologic Constriction
Myocardial Infarction
Confidence Intervals

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Yadav, J. S., Wholey, M. H., Kuntz, R. E., Fayad, P. B., Katzen, B. T., Mishkel, G. J., ... Ouriel, K. (2004). Protected carotid-artery stenting versus endarterectomy in high-risk patients. New England Journal of Medicine, 351(15), 1493-1501+1586. https://doi.org/10.1056/NEJMoa040127

Protected carotid-artery stenting versus endarterectomy in high-risk patients. / Yadav, Jay S.; Wholey, Mark H.; Kuntz, Richard E.; Fayad, Pierre B; Katzen, Barry T.; Mishkel, Gregory J.; Bajwa, Tanvir K.; Whitlow, Patrick; Strickman, Neil E.; Jaff, Michael R.; Popma, Jeffrey J.; Snead, David B.; Cutlip, Donald E.; Firth, Brian G.; Ouriel, Kenneth.

In: New England Journal of Medicine, Vol. 351, No. 15, 07.10.2004, p. 1493-1501+1586.

Research output: Contribution to journalArticle

Yadav, JS, Wholey, MH, Kuntz, RE, Fayad, PB, Katzen, BT, Mishkel, GJ, Bajwa, TK, Whitlow, P, Strickman, NE, Jaff, MR, Popma, JJ, Snead, DB, Cutlip, DE, Firth, BG & Ouriel, K 2004, 'Protected carotid-artery stenting versus endarterectomy in high-risk patients', New England Journal of Medicine, vol. 351, no. 15, pp. 1493-1501+1586. https://doi.org/10.1056/NEJMoa040127
Yadav, Jay S. ; Wholey, Mark H. ; Kuntz, Richard E. ; Fayad, Pierre B ; Katzen, Barry T. ; Mishkel, Gregory J. ; Bajwa, Tanvir K. ; Whitlow, Patrick ; Strickman, Neil E. ; Jaff, Michael R. ; Popma, Jeffrey J. ; Snead, David B. ; Cutlip, Donald E. ; Firth, Brian G. ; Ouriel, Kenneth. / Protected carotid-artery stenting versus endarterectomy in high-risk patients. In: New England Journal of Medicine. 2004 ; Vol. 351, No. 15. pp. 1493-1501+1586.
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AU - Yadav, Jay S.

AU - Wholey, Mark H.

AU - Kuntz, Richard E.

AU - Fayad, Pierre B

AU - Katzen, Barry T.

AU - Mishkel, Gregory J.

AU - Bajwa, Tanvir K.

AU - Whitlow, Patrick

AU - Strickman, Neil E.

AU - Jaff, Michael R.

AU - Popma, Jeffrey J.

AU - Snead, David B.

AU - Cutlip, Donald E.

AU - Firth, Brian G.

AU - Ouriel, Kenneth

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N2 - 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.

AB - 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.

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