Agostoni E, Beghi E, Pappadà G, Marina R, Ferrarese C
Stroke Unit, Clinica Neurologica, Università Milano-Bicocca, A.O. San Gerardo, Via Donizetti 106, I-20052 Monza, Milan, Italy.
Neurol Sci. 2005 May;26 Suppl 1:S31-3. doi: 10.1007/s10072-005-0401-1.
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.
颈动脉内膜切除术(CA)是治疗颈动脉狭窄>50%患者卒中二级预防的有效方法。最近,颈动脉血管成形术加支架置入术(CAS)已被引入,并在病例系列研究和小型临床试验中被证明是有效的。尽管已证明CAS并不逊色于CA,但这些技术在早期治疗(即短暂性脑缺血发作(TIA)或轻度卒中后的第一个月内)的比较效果尚不清楚。由于在此期间复发性卒中往往频繁出现,因此提倡早期治疗。在此背景下,我们设计了一项随机临床试验,比较CA与CAS在前一个月发生TIA或轻度卒中患者中的疗效和安全性。本文介绍了这项多中心实用随机平行组开放试验的研究设计和方法。