Double Layer Micromesh Stents Versus Closed Cell Stents for the Endovascular Treatment of Carotid Stenosis in the Current Era

Abstract

Introduction: Although several randomized control studies showed increase incidence of adverse neurological events in the 30-day post-procedure outcomes in patients with carotid stenosis treated with carotid stenting (CAS) versus endarterectomy (CEA), recent guidelines suggests promising results with CAS in high volume centres with expert surgeons1. Based on this findings, companies that produce medical devices are multiplying their efforts to design new stents structure that can better protect carotid plaque during carotid stenosis endovascular treatment to avoid plaque prolapse or micro-debris embolization. The role of real effectiveness of Anti-platelet therapy on neurological complication of CAS remains unclear. The aim of this study is to examine the incidence of new ischaemic lesions, stroke o TIA, in patients treated in our centre using a new double-layer micromesh stent versus a closed cell stent. Methods: A Prospective randomized 1:1 trial was conducted from 1st January 2016 on going to compare the outcomes of carotid stenosis treatment with double-layer micromesh stents VS closed cell stents. The primary end point was the occurrence of death and neurological adverse events (TIA /Stroke) within 30 days. Secondary end point was the occurrence major adverse cardiovascular events (MACEs), defined as MI or severe arrhythmias. 88 patients were enrolled in both arm of the study. A distal protection device was used in all cases. All patient were treated preoperatively, and for 3 months post-operatively, with double anti-aggregation therapy and underwent multiplate platelet function testing using ADP test in order to assess clopidogrel resistance and therefore shifted to ticagrelor antiplatelet therapy. Statistical analysis was conducted with SAS software, version 9.4 (SAS Institute, Inc., Cary, NC). Results: There was 41 females (46,6%) and 47 males (53,4%) In group 1 and 38 females (43.2%) and 50 males in group 2 (56,8%). No stroke or death was observed in both groups of patients. No statistical differences were observed in terms of minor neurological adverse events (TIA) within 30 days: 2 (2.7%) patient experienced peri-operative TIA, with prompt recovery, and no new findings were seen in the neuroimaging in both arm of the trial. Patients symptomatic for pre-operative TIA within 30-days were treated in 2 cases (2.7%) in Group A and in 3 case (3.4%) in group B with no neurological post-operative complications. In terms of major adverse cardiovascular events (MACEs) no MI were observed in both groups. No statistical differences were defined for severe arrhythmias compared intra-operatively in 5 patients (5.7%) in group 1 vs 2 patients (2.7%) in group B (P 0.43). Overall the to groups, 20% of the patients showed high residual platelet reactivity after clopidogrel therapy ant thus shifted to ticagrelor for effective double anti-platelet therapy. Conclusion: Primary Carotid stenting with double-layer micromesh stents showed safe and feasible results. A tendency of a slightly higher incidence of intraoperative severe arrhythmias with the double layer micromesch stent may be due to higher radial force caused by the stent structure. Real effective antiplatelet therapy may partially explain similar results with both types of stents for the treatment of internal carotid artery stenosis.