Lancet. 1991 May 25;337(8752):1235-43.
The European Carotid Surgery Trial is a multicentre trial of carotid endarterectomy for patients who, after a carotid territory non-disabling ischaemic stroke, transient ischaemic attack, or retinal infarct, are found to have a stenotic lesion in the relevant (ipsilateral) carotid artery. Over the past 10 years 2518 patients have been randomised, and the mean follow-up is now almost 3 years among the 2200 thus far available for analysis of the incidence of strokes that lasted more than 7 days. For the patients with "moderate" (30-69%) stenosis on their prerandomisation angiogram the balance of surgical risk and eventual benefit remains uncertain, and full recruitment continues. For 374 patients with only "mild" (0-29%) stenosis there was little 3-year risk of ipsilateral ischaemic stroke, even in the absence of surgery, so any 3-year benefits of surgery were small, and were outweighed by its early risks. For 778 patients with "severe" (70-99%) stenosis, however, the risks of surgery were significantly outweighed by the later benefits: although 7.5% had a stroke (or died) within 30 days of surgery, during the next 3 years the risks of ipsilateral ischaemic stroke were (by life-table analysis) an extra 2.8% for surgery-allocated and 16.8% for control patients (a sixfold reduction, p less than 0.0001). There was also a small reduction in other strokes, and at 3 years the total risk of surgical death, surgical stroke, ipsilateral ischaemic stroke, or any other stroke was 12.3% for surgery and 21.9% for control (difference 9.6% SD 3.3, 2p less than 0.01). The main concern was to avoid disabling or fatal events, and, among severe stenosis patients, 3.7% had a disabling stroke (or died) within 30 days of surgery, an extra 1.1% surgery versus 8.4% control (p less than 0.0001) had a disabling or fatal ipsilateral ischaemic stroke by 3 years, and the total 3-year risk of any disabling or fatal stroke (or surgical death) was 6.0% surgery versus 11.0% control (overall difference 5.0% SD 2.3, 2p less than 0.05); but, for disabling or fatal stroke the control risks seemed to diminish after the first year, so delay of surgery by just a few months after clinical presentation might make this overall difference non-significant.
欧洲颈动脉外科手术试验是一项多中心试验，针对那些在发生颈动脉供血区非致残性缺血性卒中、短暂性脑缺血发作或视网膜梗死之后，被发现相关（同侧）颈动脉存在狭窄性病变的患者进行颈动脉内膜切除术。在过去10年里，已有2518例患者被随机分组，对于目前可供分析持续时间超过7天的卒中发生率的2200例患者而言，平均随访时间现已接近3年。对于随机分组前血管造影显示为“中度”（30% - 69%）狭窄的患者，手术风险与最终获益之间的平衡仍不确定，全面招募工作仍在继续。对于仅存在“轻度”（0% - 29%）狭窄的374例患者，即使不进行手术，3年内同侧缺血性卒中的风险也很小，因此手术的任何3年获益都很小，且被其早期风险所抵消。然而，对于778例“重度”（70% - 99%）狭窄的患者，手术的后期获益明显超过风险：尽管7.5%的患者在手术后30天内发生了卒中（或死亡），但在接下来的3年里，通过寿命表分析，手术组同侧缺血性卒中的风险额外增加了2.8%，而对照组为16.8%（降低了6倍，p小于0.0001）。其他卒中也有小幅减少，在3年时，手术导致的死亡、手术相关卒中、同侧缺血性卒中或任何其他卒中的总风险，手术组为12.3%，对照组为21.9%（差异9.6%，标准差3.3，2p小于0.01）。主要关注点在于避免致残或致命事件，在重度狭窄患者中，3.7%的患者在手术后30天内发生了致残性卒中（或死亡），到3年时，手术组额外有1.1%发生了致残或致命的同侧缺血性卒中，而对照组为8.4%（p小于0.0001），任何致残或致命性卒中（或手术死亡）的3年总风险，手术组为6.0%，对照组为11.0%（总体差异5.0%，标准差2.3，2p小于0.05）；但是，对于致残或致命性卒中，对照组的风险在第一年之后似乎有所降低，因此在临床表现后仅延迟几个月进行手术可能会使这种总体差异变得不显著。
