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

Background: Aim of this study was to evaluate peri-proceclural incidence of new diffusion-weighted-magnetic resonance -imaging (DWMRI) brain lesions in CAS patients treated by carotid mesh sten'. (CGuandTM) or closed-cell sten'. (Wallstent r"). Methods: Consecutive patients with asymptomatic carotid stenosis 70% were submitted to preoperative DWMR1 scan, to exclude he presence of preoperative silent cerebral lesions. Patients were randomized to CGuard or Wallstent. DWMRI was performed immediately after the intervention and aL 72-hour postoperatively. Moreover, pre and postoperative Mini-Mental-State-Examination Test (MMSE) and a Montreal-Cognitive-Assessment (MoCA) test were conducted, and S10013 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 Of bilateral. S1006 values doubled at 48 h in 24 patients, and among them 12 presented new DWMRI lesions. 48-h S1006 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 periproceclural neurological damage may have extra-carotid sources. (C) 2018 The Authors. Published by Elsevier B.V.