Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis.
BACKGROUND
Carotid stenting is less invasive than endarterectomy, but it is unclear whether it is as safe in patients with symptomatic carotid-artery stenosis.


METHODS
We conducted a multicenter, randomized, noninferiority trial to compare stenting with endarterectomy in patients with a symptomatic carotid stenosis of at least 60%. The primary end point was the incidence of any stroke or death within 30 days after treatment.


RESULTS
The trial was stopped prematurely after the inclusion of 527 patients for reasons of both safety and futility. The 30-day incidence of any stroke or death was 3.9% after endarterectomy (95% confidence interval [CI], 2.0 to 7.2) and 9.6% after stenting (95% CI, 6.4 to 14.0); the relative risk of any stroke or death after stenting as compared with endarterectomy was 2.5 (95% CI, 1.2 to 5.1). The 30-day incidence of disabling stroke or death was 1.5% after endarterectomy (95% CI, 0.5 to 4.2) and 3.4% after stenting (95% CI, 1.7 to 6.7); the relative risk was 2.2 (95% CI, 0.7 to 7.2). At 6 months, the incidence of any stroke or death was 6.1% after endarterectomy and 11.7% after stenting (P=0.02). There were more major local complications after stenting and more systemic complications (mainly pulmonary) after endarterectomy, but the differences were not significant. Cranial-nerve injury was more common after endarterectomy than after stenting.


CONCLUSIONS
In this study of patients with symptomatic carotid stenosis of 60% or more, the rates of death and stroke at 1 and 6 months were lower with endarterectomy than with stenting. (ClinicalTrials.gov number, NCT00190398 [ClinicalTrials.gov].).
Mas
Jean-Louis
JL
Hôpitaux Sainte-Anne, Université René Descartes, Paris, France. jl.mas@ch-sainte-anne.fr
Chatellier
Gilles
G
Beyssen
Bernard
B
Branchereau
Alain
A
Moulin
Thierry
T
Becquemin
Jean-Pierre
JP
Larrue
Vincent
V
Lièvre
Michel
M
Leys
Didier
D
Bonneville
Jean-François
JF
Watelet
Jacques
J
Pruvo
Jean-Pierre
JP
Albucher
Jean-François
JF
Viguier
Alain
A
Piquet
Philippe
P
Garnier
Pierre
P
Viader
Fausto
F
Touzé
Emmanuel
E
Giroud
Maurice
M
Hosseini
Hassan
H
Pillet
Jean-Christophe
JC
Favrole
Pascal
P
Neau
Jean-Philippe
JP
Ducrocq
Xavier
X
D000368:Aged; D017130:Angioplasty; D016893:Carotid Stenosis / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D016894:Endarterectomy, Carotid / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D009203:Myocardial Infarction / Q000453:epidemiology; D012306:Risk; D015607:Stents / Q000009:adverse effects; D020521:Stroke / Q000453:epidemiology / Q000401:mortality; D016896:Treatment Outcome