Long-term results of carotid stenting versus endarterectomy in high-risk patients.
BACKGROUND
We previously reported that, in a randomized trial, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy for the treatment of carotid artery disease at 30 days and at 1 year. We now report the 3-year results.


METHODS
The trial evaluated carotid artery stenting with the use of an emboli-protection device as compared with endarterectomy in 334 patients at increased risk for complications from endarterectomy who had either a symptomatic carotid artery stenosis of at least 50% of the luminal diameter or an asymptomatic stenosis of at least 80%. The prespecified major secondary end point at 3 years was a composite of death, stroke, or myocardial infarction within 30 days after the procedure or death or ipsilateral stroke between 31 days and 1080 days (3 years).


RESULTS
At 3 years, data were available for 260 patients (77.8%), including 85.6% of patients in the stenting group and 70.1% of those in the endarterectomy group. The prespecified major secondary end point occurred in 41 patients in the stenting group (cumulative incidence, 24.6%; Kaplan-Meier estimate, 26.2%) and 45 patients in the endarterectomy group (cumulative incidence, 26.9%; Kaplan-Meier estimate, 30.3%) (absolute difference in cumulative incidence for the stenting group, -2.3%; 95% confidence interval, -11.8 to 7.0). There were 15 strokes in each of the two groups, of which 11 in the stenting group and 9 in the endarterectomy group were ipsilateral.


CONCLUSIONS
In our trial of patients with severe carotid artery stenosis and increased surgical risk, no significant difference could be shown in long-term outcomes between patients who underwent carotid artery stenting with an emboli-protection device and those who underwent endarterectomy. (ClinicalTrials.gov number, NCT00231270 [ClinicalTrials.gov].).
Gurm
Hitinder S
HS
University of Michigan School of Medicine, Ann Arbor, USA.
Yadav
Jay S
JS
Fayad
Pierre
P
Katzen
Barry T
BT
Mishkel
Gregory J
GJ
Bajwa
Tanvir K
TK
Ansel
Gary
G
Strickman
Neil E
NE
Wang
Hong
H
Cohen
Sidney A
SA
Massaro
Joseph M
JM
Cutlip
Donald E
DE
D000328:Adult; D000800:Angioplasty, Balloon; D016893:Carotid Stenosis / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D016894:Endarterectomy, Carotid; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D009203:Myocardial Infarction / Q000453:epidemiology / Q000517:prevention & control; D012307:Risk Factors; D015607:Stents; D020521:Stroke / Q000453:epidemiology / Q000517:prevention & control*