Stroke Research Centre, Department of Brain Repair and Rehabilitation, UCL Queen Square Institute of Neurology, University College London, London, UK.
Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Trials. 2022 Jul 27;23(1):606. doi: 10.1186/s13063-022-06429-z.
Carotid endarterectomy is currently recommended for patients with recently symptomatic carotid stenosis ≥50%, based on randomised trials conducted 30 years ago. Several factors such as carotid plaque ulceration, age and associated comorbidities might influence the risk-benefit ratio of carotid revascularisation. A model developed in previous trials that calculates the future risk of stroke based on these features can be used to stratify patients into low, intermediate or high risk. Since the original trials, medical treatment has improved significantly. Our hypothesis is that patients with carotid stenosis ≥50% associated with a low to intermediate risk of stroke will not benefit from additional carotid revascularisation when treated with optimised medical therapy. We also hypothesise that prediction of future risk of stroke in individual patients with carotid stenosis can be improved using the results of magnetic resonance imaging (MRI) of the carotid plaque.
Patients are randomised between immediate revascularisation plus OMT versus OMT alone. Suitable patients are those with asymptomatic or symptomatic carotid stenosis ≥50% with an estimated 5-year risk of stroke of <20%, as calculated using the Carotid Artery Risk score. MRI of the brain at baseline and during follow-up will be used as a blinded measure to assess the incidence of silent infarction and haemorrhage, while carotid plaque MRI at baseline will be used to investigate the hypotheses that plaque characteristics determine future stroke risk and help identify a subgroup of patients that will benefit from revascularisation. An initial analysis will be conducted after recruitment of 320 patients with baseline MRI and a minimum of 2 years of follow-up, to provide data to inform the design and sample size for a continuation or re-launch of the study. The primary outcome measure of this initial analysis is the combined 2-year rate of any clinically manifest stroke, new cerebral infarct on MRI, myocardial infarction or periprocedural death.
ECST-2 will provide new data on the efficacy of modern optimal medical therapy alone versus added carotid revascularisation in patients with carotid stenosis at low to intermediate risk of future stroke selected by individualised risk assessment. We anticipate that the results of baseline brain and carotid plaque MRI will provide data to improve the prediction of the risk of stroke and the effect of treatment in patients with carotid stenosis.
ISRCTN registry ISRCTN97744893 . Registered on 05 July 2012.
根据三十年前进行的随机试验，目前建议对近期有症状的颈动脉狭窄≥50%的患者进行颈动脉内膜切除术。颈动脉斑块溃疡、年龄和相关合并症等多种因素可能会影响颈动脉血运重建的风险效益比。以前的试验中开发的一种模型可以根据这些特征计算未来的中风风险，从而将患者分为低风险、中风险或高风险。自最初的试验以来，医学治疗有了显著的改善。我们的假设是，对于伴有低至中度中风风险的颈动脉狭窄≥50%的患者，当接受最佳药物治疗时，颈动脉再血运重建不会带来额外获益。我们还假设，使用颈动脉斑块磁共振成像（MRI）的结果可以改善个体颈动脉狭窄患者未来中风风险的预测。
将适合的患者随机分为立即血运重建加 OMT 与单独 OMT。适合的患者为无症状或有症状的颈动脉狭窄≥50%，估计 5 年中风风险<20%，使用颈动脉动脉风险评分（Carotid Artery Risk score）计算。在基线和随访期间进行脑 MRI 检查，作为盲法测量指标，以评估无症状性梗死和出血的发生率，而基线颈动脉斑块 MRI 将用于研究斑块特征是否决定未来中风风险，并帮助确定将从血运重建中获益的亚组患者。在招募 320 例基线 MRI 和至少 2 年随访的患者后，将进行初始分析，为研究的继续或重新启动提供设计和样本量数据。该初始分析的主要终点是任何临床上有症状的中风、MRI 上新脑梗死、心肌梗死或围手术期死亡的 2 年联合发生率。
ECST-2 将提供新的数据，说明在通过个体化风险评估选择的未来中风风险处于低至中度的颈动脉狭窄患者中，单独使用现代最佳药物治疗与附加颈动脉血运重建的疗效。我们预计，基线脑和颈动脉斑块 MRI 的结果将提供数据，以改善颈动脉狭窄患者中风风险的预测和治疗效果。
ISRCTN 注册处 ISRCTN88147606。于 2012 年 7 月 5 日注册。
