Restenosis after carotid artery stenting and endarterectomy: a secondary analysis of CREST, a randomised controlled trial.
Restenosis after carotid artery stenting and endarterectomy: a secondary analysis of CREST, a randomised controlled trial.
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DOI：
10.1016/s1474-4422(12)70159-x
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发表时间：
2012-09
期刊：
影响因子：
--
通讯作者：
CREST Investigators
中科院分区：
文献类型：
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作者：
Lal BK;Beach KW;Roubin GS;Lutsep HL;Moore WS;Malas MB;Chiu D;Gonzales NR;Burke JL;Rinaldi M;Elmore JR;Weaver FA;Narins CR;Foster M;Hodgson KJ;Shepard AD;Meschia JF;Bergelin RO;Voeks JH;Howard G;Brott TG;CREST Investigators
在颈动脉血管重建术动脉内膜切除术与支架置入术试验（CREST）中，对于有症状或无症状的颈动脉狭窄，颈动脉支架置入术和颈动脉内膜切除术在围手术期卒中、心肌梗死或死亡或术后同侧卒中的复合主要终点没有差异。该随机试验的第二个目的是比较再狭窄或闭塞的复合终点。在2000年12月21日至2008年7月18日期间，在美国和加拿大的117个临床中心登记的无症状或有过短暂性缺血发作、烟性黑朦或轻微中风的颈动脉狭窄患者符合CREST的资格。在这一次要分析中，主要终点是2年再狭窄或闭塞的复合。在1、6、12、24和48个月时通过双超声评估再狭窄和闭塞，并将其定义为目标动脉直径缩小至少70%，以峰值收缩速度至少3.0 m/s诊断。研究在crest认证的实验室完成，并在超声核心实验室（华盛顿大学）进行解释。通过Kaplan-Meier生存估计计算再狭窄的频率，并在2年随访期间进行比较。我们使用比例风险模型来评估基线特征与再狭窄风险之间的关系。分析是按协议进行的。CREST已在ClinicalTrials.gov注册，注册号为NCT00004732。2191名患者在30天内接受了随机分配的治疗，并进行了符合条件的超声检查（1086名患者接受了颈动脉支架置入术，1105名患者接受了颈动脉内膜切除术）。2年内，行颈动脉支架置入术的患者58例（Kaplan-Meier率6.0%），行颈动脉内膜切除术的患者62例（6.3%）发生再狭窄或闭塞（风险比[HR] 0.90, 95% CI 0.63 - 1.29; p= 0.58）。女性（1.79,1.25 - 2.56）、糖尿病（2.31,1.61 - 3.31）和血脂异常（2.07,1.01 - 4.26）是两种手术后再狭窄或闭塞的独立预测因素。吸烟预测颈动脉内膜切除术后再狭窄发生率升高（2.26,1.34 - 3.77），而颈动脉支架置入术后再狭窄发生率升高（0.77,0.41 - 1.42）。颈动脉内膜切除术和颈动脉支架置入术后2年内，再狭窄和闭塞发生率相似。部分患者可从血运重建后的早期和频繁监测中获益。国家神经疾病和中风研究所和雅培血管解决方案
In the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), the composite primary endpoint of stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke thereafter did not differ between carotid artery stenting and carotid endarterectomy for symptomatic or asymptomatic carotid stenosis. A secondary aim of this randomised trial was to compare the composite endpoint of restenosis or occlusion. Patients with stenosis of the carotid artery who were asymptomatic or had had a transient ischaemic attack, amaurosis fugax, or a minor stroke were eligible for CREST and were enrolled at 117 clinical centres in the USA and Canada between Dec 21, 2000, and July 18, 2008. In this secondary analysis, the main endpoint was a composite of restenosis or occlusion at 2 years. Restenosis and occlusion were assessed by duplex ultrasonography at 1, 6, 12, 24, and 48 months and were defined as a reduction in diameter of the target artery of at least 70%, diagnosed by a peak systolic velocity of at least 3·0 m/s. Studies were done in CREST-certified laboratories and interpreted at the Ultrasound Core Laboratory (University of Washington). The frequency of restenosis was calculated by Kaplan-Meier survival estimates and was compared during a 2-year follow-up period. We used proportional hazards models to assess the association between baseline characteristics and risk of restenosis. Analyses were per protocol. CREST is registered with ClinicalTrials.gov, number NCT00004732. 2191 patients received their assigned treatment within 30 days of randomisation and had eligible ultrasonography (1086 who had carotid artery stenting, 1105 who had carotid endarterectomy). In 2 years, 58 patients who underwent carotid artery stenting (Kaplan-Meier rate 6·0%) and 62 who had carotid endarterectomy (6·3%) had restenosis or occlusion (hazard ratio [HR] 0·90, 95% CI 0·63–1·29; p=0·58). Female sex (1·79, 1·25–2·56), diabetes (2·31, 1·61–3·31), and dyslipidaemia (2·07, 1·01–4·26) were independent predictors of restenosis or occlusion after the two procedures. Smoking predicted an increased rate of restenosis after carotid endarterectomy (2·26, 1·34–3·77) but not after carotid artery stenting (0·77, 0·41–1·42). Restenosis and occlusion were infrequent and rates were similar up to 2 years after carotid endarterectomy and carotid artery stenting. Subsets of patients could benefit from early and frequent monitoring after revascularisation. National Institute of Neurological Disorders and Stroke and Abbott Vascular Solutions