颈动脉内膜剥脱术和颈动脉支架的前瞻性随机对照研究

目的 评价颈动脉内膜剥脱术和颈动脉支架治疗颈动脉狭窄的近期和中期临床效果.方法 前瞻性单中心随机对照研究,自2004年5月至2006年12月,将同意入组的40例有症状(狭窄程度>50%)和无症状(狭窄程度>70%)颈动脉狭窄患者随机分为两组,即颈动脉内膜剥脱术组(CEA)和颈动脉支架组(CAS).一期观察终点是术后30 d内出现严重脑梗死或死亡;二期观察终点是各种手术并发症、急性脑缺血发作、偏瘫、急性心肌梗死和术后18个月内的脑卒中、死亡和再狭窄等,同时回顾性分析两组总的住院费用.结果 CEA和CAS两组患者术前一般资料、临床症状、伴随疾病等因素均无差异.CEA组20例23支颈动脉手术(3例分别行双侧CEA),术中应用转流管9条(39.1%),颈动脉补片12条(52.2%);CAS组20例23支颈动脉支架(3例行双侧CAS),应用脑保护装置21个(91.3%).CEA和CAS两组术后30 d内神经系统并发症(4.3%对8.7%,P=0.46)、急性心肌梗死(4.3%对0,P=0.31)和伤口血肿(8.7%对0,P=0.14)等差异均无统计学意义,至术后18个月无短暂性脑缺血发作和再狭窄病例.CEA和CAS两组平均住院费用分别为(16 450.95±6188.76)和(70 130.15±11 999.02)元人民币,差异有统计学意义(P<0.01).结论 CEA和CAS术后30 d和术后18个月的并发症、病死率和临床疗效无明显差异,但CAS的住院花费明显高于CEA.

Carotid endarterectomy versus carotid stenting: a prospective randomized trial

Objective To evaluate the early and midterm outcomes of carotid endarterectomy (CEA) compared with carotid stenting (CAS) in patients with carotid artery stenosis.Methods A prospective randomized single-center clinical trail to compare with endarterectomy and stenting in patients with symptomatic carotid stenosis of at least 50% and asymptomatic stenosis of at least 70%.From May 2004 to December 2006,there were 40 patients who agreed with the treatment were randomly assigned to undergo either CEA or CAS.The primary end point was any stroke or death within 30 d after treatment and the secondary end point was any stroke,myocardial infarction and any complications of the treatment,or death or ipsilateral stroke and carotid restenosis between 1 month and 18 months,and the cost-effectiveness of both groups were analyzed retrospectively as well Results There were no significant differences of the characteristics in the two groups.Twenty cases in CEA group underwent 23 endarterectomies (3 cases had bilateral CEA,respectively),in which 9 carotid shunt (39.1%) and 12 patching (52.2%) were used.Twenty cases in CAS group underwent 23 stents(3 cases had bilateral CSA,respectively),in which 21 emboli-protection devices (91.3%) were used.There was no significant difference in 30 d neurological complications (4.3% vs.8.7%),acute myocardial infarction (4.3% vs.0),and wound hematoma (8.7% vs.0) between CEA and CAS,respectively.There was no ipsilateral transient ischemic attack or carotid restenosis at 18 months in each group.The average cost of hospitalization was (16 450.95 ±6188.76) vs.(70 130.15±11 999.02) RMB in CEA and CAS,respectively,with significant difference (P<0.01).Conclusion The early and midterm outcomes are no significant difference between CEA and CAS,but in China,the cost of hospitalization in CAS is much higher than that of CEA.