Lancet. 1998 May 9;351(9113):1379-87.
Our objective was to assess the risks and benefits of carotid endarterectomy, primarily in terms of stroke prevention, in patients with recently symptomatic carotid stenosis.
This multicentre, randomised controlled trial enrolled 3024 patients. We enrolled men and women of any age, with some degree of carotid stenosis, who within the previous 6 months had had at least one transient or mild symptomatic ischaemic vascular event in the distribution of one or both carotid arteries. Between 1981 and 1994, we allocated 1811 (60%) patients to surgery and 1213 (40%) to control (surgery to be avoided for as long as possible). Follow-up was until the end of 1995 (mean 6.1 years), and the main analyses were by intention to treat.
The overall outcome (major stroke or death) occurred in 669 (37.0%) surgery-group patients and 442 (36.5%) control-group patients. The risk of major stroke or death complicating surgery (7.0%) did not vary substantially with severity of stenosis. On the other hand, the risk of major ischaemic stroke ipsilateral to the unoperated symptomatic carotid artery increased with severity of stenosis, particularly above about 70-80% of the original luminal diameter, but only for 2-3 years after randomisation. On average, the immediate risk of surgery was worth trading off against the long-term risk of stroke without surgery when the stenosis was greater than about 80% diameter; the Kaplan-Meier estimate of the frequency of a major stroke or death at 3 years was 26.5% for the control group and 14.9% for the surgery group, an absolute benefit from surgery of 11.6%. However, consideration of variations in risk with age and sex modified this simple rule based on stenosis severity. We present a graphical procedure that should improve the selection of patients for surgery.
Carotid endarterectomy is indicated for most patients with a recent non-disabling carotid-territory ischaemic event when the symptomatic stenosis is greater than about 80%. Age and sex should also be taken into account in decisions on whether to operate.
我们的目的是评估在近期有症状的颈动脉狭窄患者中，主要从预防中风的角度来看，颈动脉内膜切除术的风险和益处。
这项多中心随机对照试验纳入了3024例患者。我们纳入了任何年龄的男性和女性，他们有一定程度的颈动脉狭窄，且在过去6个月内在一侧或双侧颈动脉分布区域至少发生过一次短暂性或轻度症状性缺血性血管事件。在1981年至1994年期间，我们将1811例（60%）患者分配至手术组，1213例（40%）患者分配至对照组（尽可能长时间避免手术）。随访至1995年底（平均6.1年），主要分析采用意向性治疗。
手术组669例（37.0%）患者和对照组442例（36.5%）患者出现总体结局（严重中风或死亡）。手术并发严重中风或死亡的风险（7.0%）并未随狭窄严重程度而有显著差异。另一方面，未手术的有症状颈动脉同侧发生严重缺血性中风的风险随狭窄严重程度增加，特别是在原始管腔直径约70 - 80%以上时，但仅在随机分组后2 - 3年内如此。平均而言，当狭窄大于约80%直径时，手术的直接风险与不手术的长期中风风险进行权衡是值得的；对照组3年时严重中风或死亡发生率的Kaplan-Meier估计值为26.5%，手术组为14.9%，手术的绝对获益为11.6%。然而，考虑年龄和性别风险的差异改变了基于狭窄严重程度的这一简单规则。我们提出一种图表方法，应能改善手术患者的选择。
对于大多数近期有非致残性颈动脉供血区缺血事件且症状性狭窄大于约80%的患者，建议行颈动脉内膜切除术。在决定是否手术时也应考虑年龄和性别。
