症状性颈动脉狭窄支架置入术与内膜切除术的操作相关卒中或死亡风险的长期变化趋势。
Secular Trends in Procedural Stroke or Death Risks of Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis.
机构信息
Department of Neurology and Stroke Center (M.D.M. and L.H.B.), University Hospital Basel, University of Basel, Switzerland.
Department of Clinical Research, Clinical Trial Unit (S.v.F.), University Hospital Basel, University of Basel, Switzerland.
出版信息
Circ Cardiovasc Interv. 2019 Aug;12(8):e007870. doi: 10.1161/CIRCINTERVENTIONS.119.007870. Epub 2019 Aug 5.
BACKGROUND
Over the past decades, stroke risk associated with carotid disease has decreased, reflecting improvements in medical therapy and a more rigorous control of vascular risk factors. It is less clear whether the procedural risk of carotid revascularization has declined over time.
METHODS
We analyzed temporal changes in procedural risks among 4597 patients with symptomatic carotid stenosis treated with carotid artery stenting (n=2326) or carotid endarterectomy (n=2271) in 4 randomized trials between 2000 and 2008, using generalized linear mixed-effects models with a random intercept for each source trial. Models were additionally adjusted for age and other baseline characteristics predicting treatment risk. The primary outcome event was any procedural stroke or death, occurring during or within 30 days after revascularization.
RESULTS
The procedural stroke or death risk decreased significantly over time in all patients (unadjusted odds ratio per year, 0.91; 95% CI, 0.85-0.97; P=0.006). This effect was driven by a decrease in the carotid endarterectomy group (unadjusted odds ratio per year, 0.82; 95% CI, 0.73-0.92; P=0.003), whereas no significant decrease was found after carotid artery stenting (unadjusted odds ratio, 0.96; 95% CI, 0.88-1.04; P=0.33). Carotid endarterectomy patients had a lower procedural stroke or death risk compared with carotid artery stenting patients, and the difference significantly increased over time (interaction P=0.031). After adjustment for baseline characteristics, the results remained essentially the same.
CONCLUSIONS
The risk of stroke or death associated with carotid endarterectomy for symptomatic carotid stenosis decreased over an 8-year period, independent of clinical predictors of procedural risk. No corresponding reduction in procedural risk was seen in patients treated with stenting.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov; http://www.isrctn.com. Unique identifier: NCT00190398 (EVA-3S), NCT00004732 (CREST), ISRCTN57874028 (SPACE), and ISRCTN25337470 (ICSS).
背景
在过去的几十年中，与颈动脉疾病相关的中风风险已经降低，这反映了医学治疗的进步和对血管危险因素的更严格控制。但是否随着时间的推移，颈动脉血运重建的手术风险有所降低尚不清楚。
方法
我们使用广义线性混合效应模型，对 2000 年至 2008 年间 4 项随机试验中 4597 例有症状颈动脉狭窄患者（颈动脉支架置入术 2326 例，颈动脉内膜切除术 2271 例）的手术风险进行了时间变化分析。每个源试验都有一个随机截距。模型还根据预测治疗风险的年龄和其他基线特征进行了调整。主要结局事件是任何手术相关的中风或死亡，发生在血管重建期间或之后 30 天内。
结果
所有患者的手术相关中风或死亡风险均显著随时间降低（未经调整的每年比值比，0.91；95%可信区间，0.85-0.97；P=0.006）。这种效应是由颈动脉内膜切除术组的下降驱动的（未经调整的每年比值比，0.82；95%可信区间，0.73-0.92；P=0.003），而颈动脉支架置入术组未见显著下降（未经调整的比值比，0.96；95%可信区间，0.88-1.04；P=0.33）。与颈动脉支架置入术相比，颈动脉内膜切除术患者的手术相关中风或死亡风险较低，且该差异随时间显著增加（交互 P=0.031）。调整基线特征后，结果基本保持不变。
结论
8 年内，与症状性颈动脉狭窄相关的颈动脉内膜切除术相关的中风或死亡风险下降，与手术风险的临床预测因素无关。接受支架置入治疗的患者的手术风险没有相应降低。
临床试验注册
网址：https://www.clinicaltrials.gov；http://www.isrctn.com。唯一标识符：NCT00190398（EVA-3S），NCT00004732（CREST），ISRCTN57874028（SPACE）和 ISRCTN25337470（ICSS）。
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