Microembolization during carotid artery stenting in patients with high-risk, lipid-rich plaque. A randomized trial of proximal versus distal cerebral protection
Piero Montorsi, Luigi Caputi, Stefano Galli, Elisa Ciceri, Giovanni Ballerini, Marco Agrifoglio, Paolo Ravagnani, Daniela Trabattoni, Gianluca Pontone, Franco Fabbiocchi, Alessandro Loaldi, Eugenio Parati, Daniele Andreini, Fabrizio Veglia, Antonio L Bartorelli, Piero Montorsi, Luigi Caputi, Stefano Galli, Elisa Ciceri, Giovanni Ballerini, Marco Agrifoglio, Paolo Ravagnani, Daniela Trabattoni, Gianluca Pontone, Franco Fabbiocchi, Alessandro Loaldi, Eugenio Parati, Daniele Andreini, Fabrizio Veglia, Antonio L Bartorelli
Abstract
Objectives: The goal of this study was to compare the rate of cerebral microembolization during carotid artery stenting (CAS) with proximal versus distal cerebral protection in patients with high-risk, lipid-rich plaque.
Background: Cerebral protection with filters partially reduces the cerebral embolization rate during CAS. Proximal protection has been introduced to further decrease embolization risk.
Methods: Fifty-three consecutive patients with carotid artery stenosis and lipid-rich plaque were randomized to undergo CAS with proximal protection (MO.MA system, n = 26) or distal protection with a filter (FilterWire EZ, n = 27). Microembolic signals (MES) were assessed by using transcranial Doppler during: 1) lesion wiring; 2) pre-dilation; 3) stent crossing; 4) stent deployment; 5) stent dilation; and 6) device retrieval/deflation. Diffusion-weighted magnetic resonance imaging was conducted before CAS, after 48 h, and after 30 days.
Results: Patients in the MO.MA group had higher percentage diameter stenosis (89 ± 6% vs. 86 ± 5%, p = 0.027) and rate of ulcerated plaque (35% vs. 7.4%; p = 0.019). Compared with use of the FilterWire EZ, MO.MA significantly reduced mean MES counts (p < 0.0001) during lesion crossing (mean 18 [interquartile range (IQR): 11 to 30] vs. 2 [IQR: 0 to 4]), stent crossing (23 [IQR: 11 to 34] vs. 0 [IQR: 0 to 1]), stent deployment (30 [IQR: 9 to 35] vs. 0 [IQR: 0 to 1]), stent dilation (16 [IQR: 8 to 30] vs. 0 [IQR: 0 to 1]), and total MES (93 [IQR: 59 to 136] vs. 16 [IQR: 7 to 36]). The number of patients with MES was higher with the FilterWire EZ versus MO.MA in phases 3 to 5 (100% vs. 27%; p < 0.0001). By multivariate analysis, the type of brain protection was the only independent predictor of total MES number. No significant difference was found in the number of patients with new post-CAS embolic lesion in the MO.MA group (2 of 14, 14%) as compared with the FilterWire EZ group (9 of 21, 42.8%).
Conclusions: In patients with high-risk, lipid-rich plaque undergoing CAS, MO.MA led to significantly lower microembolization as assessed by using MES counts.
Trial registration: ClinicalTrials.gov NCT01274676.
Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed