Early invasive treatment (endarterectomy vs. stenting) of moderate-to-severe carotid stenosis in patients with transient ischaemic attack or minor stroke.
Carotid endarterectomy (CA) is an effective treatment for the secondary prevention of stroke in patients with carotid stenosis >50%. More recently, carotid angioplasty with stenting (CAS) has been introduced and found to be effective in case series and small clinical trials. Although CAS has been shown not to be inferior to CA, the comparative effects of early treatment (i.e., during the first month after transient ischaemic attack (TIA) or minor stroke) with these techniques are unknown. Early treatment is advocated, as recurrent stroke tends to present frequently in this time period. On this background, we designed a randomised clinical trial comparing the efficacy and safety of CA vs. CAS in patients who had suffered TIA or minor stroke in the antecedent month. The study design and methods of this multicentre pragmatic randomised parallel-group open trial are presented here.
Agostoni
E
E
Stroke Unit, Clinica Neurologica, Università Milano-Bicocca, A.O. San Gerardo, Via Donizetti 106, I-20052 Monza, Milan, Italy. e.agostoni@libero.it
Beghi
E
E
Pappadà
G
G
Marina
R
R
Ferrarese
C
C
D016893:Carotid Stenosis / Q000150:complications / Q000175:diagnosis / Q000601:surgery*; D016009:Chi-Square Distribution; D002985:Clinical Protocols / Q000592:standards*; D016894:Endarterectomy, Carotid / Q000379:methods; D005500:Follow-Up Studies; D006801:Humans; D002546:Ischemic Attack, Transient / Q000150:complications / Q000175:diagnosis / Q000601:surgery*; D015999:Multivariate Analysis; D016032:Randomized Controlled Trials as Topic; D018709:Statistics, Nonparametric; D015607:Stents