Department of Radiology and Neuroradiology, University Hospital Kiel, Kiel, Germany.
Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
J Neurointerv Surg. 2018 Dec;10(12):1149-1154. doi: 10.1136/neurintsurg-2017-013622. Epub 2018 Apr 19.
Carotid artery stenting is an alternative to endarterectomy for the treatment of symptomatic carotid stenosis but was associated with a higher risk of procedural stroke or death in randomized controlled trials (RCTs). Technical aspects of treatment may partly explain these results. The purpose of this analysis was to investigate the influence of technical aspects such as stent design or the use of protection devices, as well as clinical variables, on procedural risk.
We pooled data of 1557 individual patients receiving stent treatment in three large RCTs comparing stenting versus endarterectomy for symptomatic carotid stenosis. The primary outcome event was any procedural stroke or death occurring within 30 days after stenting.
Procedural stroke or death occurred significantly more often with the use of open-cell stents (61/595 patients, 10.3%) than with closed-cell stents (58/962 patients, 6.0%; RR 1.76; 95% CI 1.23 to 2.52; P=0.002). Procedural stroke or death occurred in 76/950 patients (8.0%) treated with protection devices (predominantly distal filters) and in 43/607 (7.1%) treated without protection devices (RR 1.10; 95% CI 0.71 to 1.70; P=0.67). Clinical variables predicting the primary outcome event were age, severity of the qualifying event, history of prior stroke, and level of disability at baseline. The effect of stent design remained similar after adjustment for these variables.
In symptomatic carotid stenosis, the use of stents with a closed-cell design is independently associated with a lower risk of procedural stroke or death compared with open-cell stents. Filter-type protection devices do not appear to reduce procedural risk.
颈动脉支架置入术是治疗症状性颈动脉狭窄的一种替代方法，但在随机对照试验（RCT）中与更高的手术卒中或死亡风险相关。治疗的技术方面可能部分解释了这些结果。本分析的目的是研究支架设计或使用保护装置等技术方面以及临床变量对手术风险的影响。
我们汇总了三项比较症状性颈动脉狭窄支架置入术与颈动脉内膜切除术的大型 RCT 中 1557 例接受支架治疗的患者数据。主要终点事件是支架置入后 30 天内任何手术卒中或死亡。
与使用闭孔支架（595 例患者中有 61 例，10.3%）相比，使用开孔支架（962 例患者中有 58 例，6.0%；RR 1.76；95%CI 1.23 至 2.52；P=0.002）更常发生手术卒中或死亡。使用保护装置（主要是远端过滤器）治疗的 950 例患者中有 76 例（8.0%）和未使用保护装置治疗的 607 例患者中有 43 例（7.1%）发生手术卒中或死亡（RR 1.10；95%CI 0.71 至 1.70；P=0.67）。预测主要终点事件的临床变量为年龄、 qualifying 事件的严重程度、既往卒中史和基线残疾程度。在调整这些变量后，支架设计的效果仍然相似。
在症状性颈动脉狭窄中，与开孔支架相比，使用闭孔设计的支架与较低的手术卒中或死亡风险相关。滤器型保护装置似乎不会降低手术风险。
