title: Randomized comparison of distal and proximal cerebral protection during carotid artery stenting.
abstract: OBJECTIVE
  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.
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil. Electronic address: sjcano@terra.com.br.
authors.forename: Manuel N
authors.initials: MN
authors.lastname: Cano
authors.forename: Antônio M
authors.initials: AM
authors.lastname: Kambara
authors.forename: Silvia J F
authors.initials: SJ
authors.lastname: de Cano
authors.forename: Luiz Antônio
authors.initials: LA
authors.lastname: Pezzi Portela
authors.forename: Ângela Tavares
authors.initials: ÂT
authors.lastname: Paes
authors.forename: J Ribamar
authors.initials: JR
authors.lastname: Costa
authors.forename: Alexandre Antônio Cunha
authors.initials: AA
authors.lastname: Abizaid
authors.forename: Samuel Martins
authors.initials: SM
authors.lastname: Moreira
authors.forename: Amanda G M R
authors.initials: AG
authors.lastname: Sousa
authors.forename: J Eduardo Moraes Rego
authors.initials: JE
authors.lastname: Sousa
mesh_terms: D000368:Aged; D017130:Angioplasty / Q000009:adverse effects / Q000295:instrumentation*; D058070:Asymptomatic Diseases; D002545:Brain Ischemia / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D001938:Brazil; D016893:Carotid Stenosis / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D002560:Cerebrovascular Circulation; D016009:Chi-Square Distribution; D038524:Diffusion Magnetic Resonance Imaging; D057505:Embolic Protection Devices; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011237:Predictive Value of Tests; D057216:Propensity Score; D011446:Prospective Studies; D012307:Risk Factors; D015607:Stents; D020521:Stroke / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome
keywords: CAS; CEA; CPD; DW-MRI; carotid artery stenting; carotid endarterectomy; cerebral protection device; diffusion-weighted MRI; diffusion-weighted magnetic resonance imaging