J Endovasc Ther. 2003 Dec;10(6):1021-30. doi: 10.1177/152660280301000601.
To determine whether carotid stenting with embolic protection is equivalent to carotid endarterectomy (CEA) in a broad risk population of patients with symptomatic and asymptomatic carotid stenosis.
A prospective, multicenter Phase I trial was conducted comparing standard CEA to carotid stenting systems (CSS) in patients with symptomatic (> or =50%) and asymptomatic (> or =75%) carotid stenosis. Patients were enrolled using selection criteria reflective of broad clinical practice. The enrollment ratio at each clinical site was designed to be 2:1 (CEA to CSS) to achieve a planned enrollment of 450 patients: 300 in the CEA arm and 150 in the CSS cohort, which would ensure adequate precision with a coefficient of variation < or =0.35. The primary endpoint for comparison was 30-day all-cause mortality and nonfatal stroke.
Between April 2001 and December 2002, 14 clinical sites enrolled 439 patients, of which 397 (247 men; mean age 71 years, range 44-89) were treated: 254 with CEA and 143 patients with CSS (ratio 1.8 to 1.0). More than 90% of patients had >75% stenosis; approximately 68% of patients were asymptomatic. There were no significant differences in baseline patient characteristics between the treatment groups with the exception of a more frequent history of prior CEA (30% CSS versus 11% for CEA, p<0.0001) and prior carotid stent placement in the CSS group (6% versus 0% for CEA, p=0.0002). There was no significant difference in the 30-day combined all-cause mortality and stroke rate by Kaplan-Meier estimate between CEA (2%) and CSS (2%). There was no significant difference in the secondary endpoint of combined 30-day all-cause mortality, stroke, and myocardial infarction between CEA (3%) and CSS (2%).
This study suggests that the 30-day risk of stroke or death following carotid stenting with cerebral protection is equivalent to standard carotid endarterectomy in a broad risk population of patients with carotid stenosis.
确定在有症状和无症状颈动脉狭窄的广泛风险人群中，使用栓子保护装置的颈动脉支架置入术是否等同于颈动脉内膜切除术（CEA）。
进行了一项前瞻性多中心I期试验，比较标准CEA与颈动脉支架系统（CSS）在有症状（≥50%）和无症状（≥75%）颈动脉狭窄患者中的效果。使用反映广泛临床实践的选择标准招募患者。每个临床站点的入组比例设计为2:1（CEA对CSS），以实现计划招募450名患者：CEA组300名，CSS队列150名，这将确保变异系数≤0.35时具有足够的精度。比较的主要终点是30天全因死亡率和非致命性卒中。
在2001年4月至2002年12月期间，14个临床站点招募了439名患者，其中397名（247名男性；平均年龄71岁，范围44 - 89岁）接受了治疗：254名接受CEA治疗，143名接受CSS治疗（比例为1.8比1.0）。超过90%的患者狭窄程度>75%；约68%的患者无症状。治疗组之间的基线患者特征无显著差异，但CSS组既往CEA病史更常见（30%对CEA组的11%，p<0.0001），且CSS组有既往颈动脉支架置入史（6%对CEA组的0%，p = 0.0002）。根据Kaplan-Meier估计，CEA组（2%）和CSS组（2%）的30天全因死亡率和卒中率联合起来无显著差异。CEA组（3%）和CSS组（2%）在30天全因死亡率、卒中和心肌梗死联合这一次要终点上无显著差异。
本研究表明，在颈动脉狭窄的广泛风险人群中，采用脑保护的颈动脉支架置入术后30天发生卒中或死亡的风险等同于标准颈动脉内膜切除术。
