Randomized comparison of distal and proximal cerebral protection during carotid artery stenting
Manuel N Cano, Antônio M Kambara, Silvia J F de Cano, Luiz Antônio Pezzi Portela, Ângela Tavares Paes, J Ribamar Costa Jr, Alexandre Antônio Cunha Abizaid, Samuel Martins Moreira, Amanda G M R Sousa, J Eduardo Moraes Rego Sousa, Manuel N Cano, Antônio M Kambara, Silvia J F de Cano, Luiz Antônio Pezzi Portela, Ângela Tavares Paes, J Ribamar Costa Jr, Alexandre Antônio Cunha Abizaid, Samuel Martins Moreira, Amanda G M R Sousa, J Eduardo Moraes Rego Sousa
Abstract
Objectives: This study sought to randomly compare cerebral protection with ANGIOGUARD (Cordis Corporation, Bridgewater, New Jersey) with Mo.Ma (Invatec/Medtronic Vascular Inc, Santa Rosa, California) during carotid artery stenting (CAS), using diffusion-weighted magnetic resonance imaging (DW-MRI) to detect new ischemic cerebral lesions. The number, size, and location of lesions were analyzed.
Background: The choice of the type of cerebral protection during CAS is controversial.
Methods: From July 2008 to July 2011, 60 patients undergoing CAS were randomized to ANGIOGUARD or Mo.Ma, distributed by chance, 30 patients for each group. All patients underwent DW-MRI before and after CAS. An independent neuroradiologist blinded to the cerebral protection used analyzed the images. Univariate and multivariate logistic models were fitted to analyze new ischemic lesions. Alternatively, a propensity score approach was used to reduce the bias due to differences between the groups. For the number of lesions, we used Poisson regression models.
Results: New ischemic lesions seen on DW-MRI were present in 63.3% of the ANGIOGUARD group versus 66.7% of the Mo.Ma cohort (p = 0.787). The number of ischemic cerebral lesions per patient, when present, was significantly lower in the Mo.Ma group (a median of 6 lesions per patient vs. a median of 10 in the ANGIOGUARD, p < 0.001). Most lesions were small (<0.5 mm) and localized in the ipsilateral territory. One patient in the ANGIOGUARD group had a minor stroke during CAS (1.66%).
Conclusions: New ischemic lesions seen on DW-MRI were present in both groups in >60%, but the number of lesions per patient was greater in the ANGIOGUARD group. No death or disabling stroke occurred during at least 1 year of follow-up in both cohorts.
Keywords: CAS; CEA; CPD; DW-MRI; carotid artery stenting; carotid endarterectomy; cerebral protection device; diffusion-weighted MRI; diffusion-weighted magnetic resonance imaging.
Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed