Department of Surgery, IRCCS Istituto Auxologico Italiano, Milan, Italy.
Department of Vascular Surgery, Policlinico Di Monza Hospital, Monza, Italy.
Eur J Vasc Endovasc Surg. 2017 Dec;54(6):681-687. doi: 10.1016/j.ejvs.2017.09.015. Epub 2017 Oct 28.
OBJECTIVE/BACKGROUND: Plaque protrusion through stent struts represents one of the principal causes of cerebral embolisation during carotid artery stenting (CAS) and the stent healing period. The aim of this study was to evaluate the safety (technical success) and efficacy (clinical success) of the CGuard stent system - a new nitinol stent covered by a closed-cell polyethylene terephthalate mesh designed to prevent embolic events.
Eighty-two consecutive patients who underwent CAS with CGuard from June 2015 were included in this study. The same surgeon performed all procedures. Primary endpoints included technical and clinical success. Clinical success was considered to be absence of death, major or minor stroke. The incidence of new ischaemic brain lesions was also evaluated by diffusion weighted magnetic resonance imaging (DW-MRI) in a subgroup of patients as a secondary endpoint.
In this study, 82 patients (73.8 ± 8.5 years, 75% male, 19% symptomatic) underwent CAS procedures. Immediate technical success was 100%, with the stenosis diameter reduced from 81.4 ± 4.9% to 11.0 ± 3.5%. There was peri-operative technical and clinical success in 100% of symptomatic patients, and in 98.5% of asymptomatic patients, because of the occurrence of one acute stent thrombosis 4 hours post-CAS followed by a minor stroke. In the post-operative period (30 days), no new events were registered. The most recent 21 patients (24%) underwent DW-MRI in the peri-operative period: new ischaemic brain lesions were recorded in 23.8% of patients and the average lesion volume per patients was 0.039 ± 0.025 cm.
The technical and clinical outcomes of this single centre study suggest that the CGuard may be a safe and effective device for endovascular treatment of symptomatic and asymptomatic subjects, independent of aortic arch anatomy. Further larger comparative studies are needed to confirm these benefits.
目的/背景：支架梁突入是颈动脉支架置入术（CAS）期间和支架愈合期发生脑栓塞的主要原因之一。本研究旨在评估 CGuard 支架系统的安全性（技术成功）和疗效（临床成功）——这是一种新型的覆盖有闭孔聚对苯二甲酸乙二醇酯网的镍钛诺支架，旨在预防栓塞事件。
本研究纳入了 2015 年 6 月以来接受 CGuard 治疗的 82 例连续患者。所有手术均由同一位外科医生进行。主要终点包括技术和临床成功。临床成功定义为无死亡、大或小卒中。在患者亚组中，还通过弥散加权磁共振成像（DW-MRI）评估了新的缺血性脑损伤的发生率，作为次要终点。
在这项研究中，82 例患者（73.8±8.5 岁，75%为男性，19%为症状性）接受了 CAS 手术。即刻技术成功率为 100%，狭窄程度从 81.4±4.9%降低至 11.0±3.5%。在 100%的症状性患者和 98.5%的无症状患者中，围手术期技术和临床均取得成功，因为有 1 例患者在 CAS 后 4 小时发生急性支架内血栓形成，随后发生小卒中。在术后期间（30 天），未发生新的事件。最近的 21 例（24%）患者在围手术期进行了 DW-MRI，23.8%的患者记录到新的缺血性脑损伤，每位患者的平均病变体积为 0.039±0.025cm。
这项单中心研究的技术和临床结果表明，CGuard 可能是一种安全有效的治疗方法，适用于有症状和无症状的患者，与主动脉弓解剖无关。需要进一步的更大规模的比较研究来证实这些益处。
