有症状颈动脉狭窄内膜切除术随机对照试验的汇总数据分析。

Analysis of pooled data from the randomised controlled trials of endarterectomy for symptomatic carotid stenosis.

作者信息

Rothwell P M, Eliasziw M, Gutnikov S A, Fox A J, Taylor D W, Mayberg M R, Warlow C P, Barnett H J M

机构信息

Stroke Prevention Research Unit, University Department of Clinical Neurology, Radcliffe Infirmary, Oxford, UK.

出版信息

Lancet. 2003 Jan 11;361(9352):107-16. doi: 10.1016/s0140-6736(03)12228-3.

DOI:10.1016/s0140-6736(03)12228-3

PMID:12531577

Abstract

BACKGROUND

Endarterectomy reduces risk of stroke in certain patients with recently symptomatic internal carotid stenosis. However, investigators have made different recommendations about the degree of stenosis above which surgery is effective, partly because of differences between trials in the methods of measurement of stenosis. To accurately assess the overall effect of surgery, and to increase power for secondary analyses, we pooled trial data and reassessed carotid angiograms.

METHODS

We pooled data from the European Carotid Surgery Trial (ECST), North American Symptomatic Carotid Endarterectomy Trial, and Veterans Affairs trial 309 from the original electronic data files. Outcome events were re-defined, if necessary, to achieve comparability. Pre-randomisation carotid angiograms from ECST were re-measured by the method used in the other two trials.

RESULTS

Risks of main outcomes in both treatment groups and effects of surgery did not differ between trials. Data for 6092 patients, with 35000 patient-years of follow-up, were therefore pooled. Surgery increased the 5-year risk of ipsilateral ischaemic stroke in patients with less than 30% stenosis (n=1746, absolute risk reduction -2.2%, p=0.05), had no effect in patients with 30-49% stenosis (1429, 3.2%, p=0.6), was of marginal benefit in those with 50-69% stenosis (1549, 4.6%, p=0.04), and was highly beneficial in those with 70% stenosis or greater without near-occlusion (1095, 16.0%, p<0.001). There was a trend towards benefit from surgery in patients with near-occlusion at 2 years' follow-up (262, 5.6%, p=0.19), but no benefit at 5 years (-1.7%, p=0.9).

INTERPRETATION

Re-analysis of the trials with the same measurements and definitions yielded highly consistent results. Surgery is of some benefit for patients with 50-69% symptomatic stenosis, and highly beneficial for those with 70% symptomatic stenosis or greater but without near-occlusion. Benefit in patients with carotid near-occlusion is marginal in the short-term and uncertain in the long-term.

摘要

背景

内膜切除术可降低近期出现症状的颈内动脉狭窄患者的中风风险。然而，对于手术有效的狭窄程度，研究人员给出了不同的建议，部分原因是各试验在狭窄测量方法上存在差异。为准确评估手术的总体效果，并提高二次分析的效能，我们汇总了试验数据并重新评估了颈动脉血管造影。

方法

我们从欧洲颈动脉外科试验（ECST）、北美症状性颈动脉内膜切除术试验以及退伍军人事务部试验309的原始电子数据文件中汇总数据。如有必要，对结局事件进行重新定义以实现可比性。采用其他两项试验使用的方法对ECST随机分组前的颈动脉血管造影进行重新测量。

结果

各试验中两个治疗组的主要结局风险及手术效果并无差异。因此，汇总了6092例患者的数据，随访时间达35000患者年。手术增加了狭窄程度小于30%患者同侧缺血性中风的5年风险（n = 1746，绝对风险降低-2.2%，p = 0.05），对狭窄程度为30%-49%的患者无影响（1429例，3.2%，p = 0.6），对狭窄程度为50%-69%的患者有边际效益（1549例，4.6%，p = 0.04），对狭窄程度为70%及以上且无近乎闭塞的患者非常有益（1095例，16.0%，p<0.001）。在2年随访时，手术对近乎闭塞的患者有获益趋势（262例，5.6%，p = 0.19），但在5年时无获益（-1.7%，p = 0.9）。