Randomized Trial of Stent versus Surgery for Asymptomatic Carotid Stenosis
Randomized Trial of Stent versus Surgery for Asymptomatic Carotid Stenosis
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DOI：
10.1056/nejmoa1515706
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发表时间：
2016-03-17
影响因子：
158.5
通讯作者：
Gray, William
中科院分区：
文献类型：
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作者：
Rosenfield, Kenneth;Matsumura, Jon S.;Gray, William
背景：先前的临床试验表明，颈动脉支架植入术与捕获和清除栓子的装置，（“栓塞保护”）是一种有效的替代颈动脉内膜切除术的患者在平均或高风险的手术并发症。方法在这项试验中，我们比较了在79岁或更年轻的患有严重颈动脉狭窄且无症状的患者中，采用栓塞保护的颈动脉支架植入术和颈动脉内膜切除术（也就是说，在入组前180天内没有中风、短暂性脑缺血发作或一过性黑蒙），并且不被认为具有手术并发症的高风险。该试验设计招募1658名患者，但由于招募缓慢，在1453名患者接受随机分组后提前停止。患者随访长达5年。术后30天内死亡、卒中或心肌梗死或1年内同侧卒中的主要复合终点以3个百分点的非劣效性界值进行检验，就主要复合终点而言，支架植入术非劣效于动脉内膜切除术（事件发生率分别为3.8%和3.4%;非劣效性P = 0.01）。30天内的卒中或死亡率在支架组中为2.9%，在动脉内膜切除术组中为1.7%（P = 0.33）。术后30天至5年，支架组和动脉内膜切除术组的无同侧卒中率分别为97.8%和97.3%（P = 0.51），总生存率分别为87.1%和89.4%（P = 0.21）。支架组和动脉内膜切除术组的累积5年无卒中生存率分别为93.1%和94.7%（P = 0.44）。CONCLUSIONSIn this trial involved symptomatic patients with severe carotid stenosis who were not at high risk for surgical complications，支架组在1年的主要复合终点方面不劣于动脉内膜切除术。在包括长达5年随访的分析中，研究组之间的非手术相关卒中、所有卒中和生存率无显著差异。
BACKGROUNDPrevious clinical trials have suggested that carotid-artery stenting with a device to capture and remove emboli ("embolic protection") is an effective alternative to carotid endarterectomy in patients at average or high risk for surgical complications.METHODSIn this trial, we compared carotid-artery stenting with embolic protection and carotid endarterectomy in patients 79 years of age or younger who had severe carotid stenosis and were asymptomatic (i.e., had not had a stroke, transient ischemic attack, or amaurosis fugax in the 180 days before enrollment) and were not considered to be at high risk for surgical complications. The trial was designed to enroll 1658 patients but was halted early, after 1453 patients underwent randomization, because of slow enrollment. Patients were followed for up to 5 years. The primary composite end point of death, stroke, or myocardial infarction within 30 days after the procedure or ipsilateral stroke within 1 year was tested at a noninferiority margin of 3 percentage points.RESULTSStenting was noninferior to endarterectomy with regard to the primary composite end point (event rate, 3.8% and 3.4%, respectively; P = 0.01 for noninferiority). The rate of stroke or death within 30 days was 2.9% in the stenting group and 1.7% in the endarterectomy group (P = 0.33). From 30 days to 5 years after the procedure, the rate of freedom from ipsilateral stroke was 97.8% in the stenting group and 97.3% in the endarterectomy group (P = 0.51), and the overall survival rates were 87.1% and 89.4%, respectively (P = 0.21). The cumulative 5-year rate of stroke-free survival was 93.1% in the stenting group and 94.7% in the endarterectomy group (P = 0.44).CONCLUSIONSIn this trial involving asymptomatic patients with severe carotid stenosis who were not at high risk for surgical complications, stenting was noninferior to endarterectomy with regard to the rate of the primary composite end point at 1 year. In analyses that included up to 5 years of follow-up, there were no significant differences between the study groups in the rates of non-procedure-related stroke, all stroke, and survival.