Protected carotid-artery stenting versus endarterectomy in high-risk patients.
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.
Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH 44195, USA. yadavj@ccf.org
Jay S
JS
Yadav
Mark H
MH
Wholey
Richard E
RE
Kuntz
Pierre
P
Fayad
Barry T
BT
Katzen
Gregory J
GJ
Mishkel
Tanvir K
TK
Bajwa
Patrick
P
Whitlow
Neil E
NE
Strickman
Michael R
MR
Jaff
Jeffrey J
JJ
Popma
David B
DB
Snead
Donald E
DE
Cutlip
Brian G
BG
Firth
Kenneth
K
Ouriel
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000295:instrumentation; D016893:Carotid Stenosis / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D015897:Comorbidity; D018572:Disease-Free Survival; D004617:Embolism / Q000517:prevention & control / Q000628:therapy; D016894:Endarterectomy, Carotid; D004867:Equipment Design; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D009203:Myocardial Infarction / Q000517:prevention & control; D012307:Risk Factors; D015607:Stents; D020521:Stroke / Q000517:prevention & control