Peri-procedural brain lesions prevention in CAS (3PCAS): Randomized trial comparing CGuard™ stent vs. Wallstent™

Abstract

Background: Aim of this study was to evaluate peri-procedural incidence of new diffusion-weighted-magneticresonance-imaging (DWMRI) brain lesions in CAS patients treated by carotid mesh stent (CGuard™) or closed-cell stent (Wallstent™). Methods: Consecutive patients with asymptomatic carotid stenosis ≥ 70% were submitted to preoperative DW-MRI scan, to exclude the presence of preoperative silent cerebral lesions. Patients were randomized to CGuard or Wallstent. DWMRI was performed immediately after the intervention and at 72-hour postoperatively. Moreover, pre and postoperative Mini-Mental-State-Examination Test (MMSE) and a Montreal-Cognitive-Assessment (MoCA) test were conducted, and S100β and NSE neurobiomarkers were measured at 5-time points (preoperatively, 2, 12, 24, and 48 h postoperatively). Results: From January 2015 to October 2016, sixty-one consecutive eligible patients were submitted to preoperative DWMRI scan. Three patients were excluded because of preoperative silent cerebral lesions. In 29 CGuard patients, 1 developed a minor stroke and 8 silent new lesions were observed in the 72 h-DWMRI (31%): 4 lesions were ipsilateral, and 4 lesions were contra or bilateral. In 29 Wallstent patients, 7 clinically-silent new lesions were found in the 72 h-DWMRI (24.1%; p = 0.38). In 4 cases lesions were ipsilateral and in 3 cases contra or bilateral. S100B values doubled at 48 h in 24 patients, and among them 12 presented new DWMRI lesions. 48-h S100B increase was significantly related to 72-h DWMRI lesions (p = 0.012). Conclusions: In our experience both stents showed an acceptable rate of subclinical neurological events with no significant differences at 72-hour DWMRI between groups. Bilateral/contralateral lesions suggest that periprocedural neurological damage may have extra-carotid sources.

Carotid Artery Stenting Using a Closed-Cell Stent-in-Stent Technique for Unstable Plaque

“…However, recent studies with CGUARD reported that new ipsilateral ischemic lesions occurred in 31%% to 37% of cases. 9,24 Our results seemed be similar or superior to those reported in the CGUARD studies, although baseline characteristics of the patients were different. The closed-cell stent-in-stent technique might be an alternative to micromesh stents.…”

Contemporary Results of Carotid Artery Stenting Using Low-Profile Dual-Metal Layer Nitinol Micromesh Stents in Relation to Single-Layer Carotid Stents

“…Despite some benefits expected from the use of closedcell stents, dueto their low flexibility, the delivery of closedcell stents may be difficult in tortuous vessels. 29 To address this important limitation, new carotid stents, known as duallayered mesh-covered carotid stent systems, were introduced. This technology combines optimal flexibility (open-cell stents feature) with improved embolic prevention (closed-cell stents feature).…”

“…In particular, the micromesh of the Roadsaver/Casper and Cguard stents was designed to allow trapping debris between the stent scaffold and the vessel wall. 15,29,30 Plaque prolapse, as assessed by optical coherence tomography (OCT), was demonstrated to be a rare event whenusing micromesh stents. 15,24,31,32 Nerla et al 15 demonstrated that plaque material did not go beyond the second row of struts of the double mesh stent in all patients assessed with OCT, being entrapped between the 2 layers of struts.…”

Commentary: Double-Layer Carotid Stents: From the Clinical Need, through a Stent-in-Stent Strategy, to Effective Plaque Isolation… the Journey Toward Safe Carotid Revascularization Using the Endovascular Route

“…59 It is important to note that the outcome difference between the conventional-stent CAS vs CEA and between the conventional-stent CAS vs a dual-layer stent CAS likewise is driven by high-risk patients and plaques. 16,[33][34][35][36][37] Therefore, to provide clinically-relevant answers, carotid revascularization studies should strive to include highrisk 58,59 rather than low-risk 60 patients. As evidenced in cardiovascular studies in other areas, inclusion of low(er)-risk patients and low(er)-risk lesions (while assigning their high(er)-risk counterparts to intervention outside the study) leads to generating "answers" that are not relevant to clinical practice involving significant proportions of high-risk patients.…”

“…As evidenced in cardiovascular studies in other areas, inclusion of low(er)-risk patients and low(er)-risk lesions (while assigning their high(er)-risk counterparts to intervention outside the study) leads to generating “answers” that are not relevant to clinical practice involving significant proportions of high-risk patients. 60 An example is a recent randomized study of coronary thrombus aspiration in acute myocardial infarction where one fundamental reason not to enroll in the study was the operator’s conviction that the patient required the study-tested intervention. 61 While this is certainly right ethically, such studies are no longer able to provide answers relevant to real-life patient management.…”