Voss Yves Leonard, Zidan Mousa, Radbruch Alexander, Fischer Igor, Dorn Franziska, Nordmeyer Hannes
Department of Diagnostic and Interventional Neuroradiology, University Hospital Bonn, Bonn, Germany.
Department of Diagnostic and Interventional Neuroradiology, Klinikum Solingen, Solingen, Germany.
Neuroradiology. 2025 Sep 8. doi: 10.1007/s00234-025-03764-1.
This study aims to evaluate the safety and efficacy of the CGuard dual-layer stent with its mesh embolic protection system (EPS) in elective cases for treatment of internal carotid artery stenosis and compares it to the Carotid Wallstent as benchmark.
In this retrospective, multicenter study, we analyzed data from consecutive patients who underwent carotid artery stenting with CGuard at two high-volume neurointerventional centers and compared them with prior consecutive patients treated with Carotid Wallstent (CWS), with and without a balloon guiding catheter (BGC) as protection, at the same institutions. Patient demographics, procedural details, clinical complications, early in-stent thrombosis and occlusion rates, and late follow-up restenosis rates were assessed.
A total of 428 patients were treated, 144 with the CGuard stent, 203 with CWS + BGC and 83 with CWS-BGC, the majority of patients for symptomatic stenoses. Technical success was achieved in 98.6% of CGuard patients. No clinical complications were observed in CGuard patients, however the clinical complication rate was 2.96% (6/203) for CWS + BGC and 4.94% (4/83) for CWS-BGC patients (p = 0.052). The in-hospital stent occlusion rate was 0.69% (1/144) for CGuard and 2.1% (6/286) in CWS ± BGC patients (p = 0.49). On long-term follow-up (mean 9.9 months) the CGuard demonstrated a comparatively low rate of restenosis (6.25%) and retreatment (2.1%).
The CGuard dual-layer stent was safe and effective for carotid artery stenting in our series. Its design appears to contribute to a low risk of periprocedural complications, high technical success rate, while maintaining restenosis rates comparable to the Carotid Wallstent.
本研究旨在评估采用带有网孔栓塞保护系统（EPS）的CGuard双层支架治疗颈内动脉狭窄择期病例的安全性和有效性，并将其与作为基准的颈动脉Wallstent支架进行比较。
在这项回顾性多中心研究中，我们分析了在两个高容量神经介入中心接受CGuard颈动脉支架置入术的连续患者的数据，并将其与同一机构之前接受颈动脉Wallstent（CWS）治疗的连续患者进行比较，后者分别使用和不使用球囊引导导管（BGC）作为保护措施。评估了患者的人口统计学特征、手术细节、临床并发症、早期支架内血栓形成和闭塞率以及晚期随访再狭窄率。
共治疗了428例患者，其中144例使用CGuard支架，203例使用CWS + BGC，83例使用CWS - BGC，大多数患者为有症状的狭窄。98.6%的CGuard患者手术成功。CGuard患者未观察到临床并发症，然而，CWS + BGC患者的临床并发症发生率为2.96%（6/203），CWS - BGC患者为4.94%（4/83）（p = 0.052）。CGuard患者的院内支架闭塞率为0.69%（1/144），CWS ± BGC患者为2.1%（6/286）（p = 0.49）。在长期随访（平均9.9个月）中，CGuard显示出相对较低的再狭窄率（6.25%）和再次治疗率（2.1%）。
在我们的系列研究中，CGuard双层支架用于颈动脉支架置入术是安全有效的。其设计似乎有助于降低围手术期并发症风险，提高技术成功率，同时保持与颈动脉Wallstent支架相当的再狭窄率。
