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Doctoral Thesis
DOI
10.11606/T.17.2014.tde-06102014-200228
Document
Author
Full name
Luís Henrique de Castro Afonso
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
Ribeirão Preto, 2014
Supervisor
Committee
Abud, Daniel Giansante (President)
Rodrigues, Alfredo Jose
Caldas, José Guilherme Mendes Pereira
Leite, João Pereira
Martins, Sheila Cristina Ouriques
Title in Portuguese
Estudo randomizado comparativo entre duas técnicas de proteção embólica cerebral no tratamento endovascular das estenoses carotídeas
Keywords in Portuguese
Angioplastia de carotida
Estenose carotidea
Filtro de protecao
Lesoes isquemicas cerebrais
Reversao de fluxo
Abstract in Portuguese
O acidente vascular cerebral (AVC) e a primeira causa de obito no Brasil e a principal de incapacidade no mundo. A doenca aterosclerotica carotidea esta associada a cerca de 15% dos AVC. A endarterectomia cirurgica e o tratamento padrao-­ouro para as estenoses carotideas sintomaticas. A angioplastia carotidea com stent via endovascular (ACS) e uma alternativa terapeutica a endarterectomia. O desenvolvimento de dispositivos de protecao embolica levou a reducao das taxas de complicacao durante a ACS. A tecnica de protecao mais utilizada na pratica clinica e a protecao distal com filtro. As estrategias de protecao proximal, por bloqueio ou reversao do fluxo carotideo, tem revelado resultados promissores em relacao a protecao distal com filtro durante a ACS. Assim, o objetivo do estudo foi comparar a reversao de fluxo e o filtro de protecao durante a ACS. Os objetivos primarios foram a incidencia, o numero e o tamanho das lesoes cerebrais isquemicas por ressonancia magnetica pela sequencia diffusion-­weighted-­imaging (DWI) apos a ACS. Os objetivos secundarios foram as complicacoes cardiacas e eventos cerebrovasculares (CCEC), ataque isquemico transitorio (AIT) e as lesoes cerebrais isquemicas definitivas na imagem por ressonancia magnetica pela sequencia fluid-­attenuated inversion recovery (FLAIR) no seguimento de tres meses. As lesoes isquemicas foram obtidas por ressonancia magnetica (RM) de campo 3 Tesla. Os pacientes foram avaliados quanto aos desfechos neurologicos atraves das escalas do National Institutes of Health Stroke Scale (NIHSS) e modified Rankin Scale (mRS). Quarenta pacientes foram incluidos randomicamente no estudo. Comparado a reversao de fluxo (n=21) o filtro de protecao (n=19) resultou em uma reducao significativa na incidencia (15,8% vs. 47,6%, p=0,03), no numero (0,73 vs. 2,6, p=0,05) e no tamanho (0,81 vs. 2,23 mm, p=0,05) das novas lesoes cerebrais isquemicas. Dois pacientes, um de cada grupo, apresentaram AIT no seguimento de tres meses. Nao foram observadas CCEC na internacao ou no seguimento de tres meses. Neste estudo, o filtro de protecao mais eficaz que a reversao de fluxo na protecao cerebral durante a angioplastia carotidea com stent por acesso femoral.
Title in English
Flow-­reversal versus filter protection: a pilot carotid artery stenting randomized trial
Keywords in English
Carotid angioplasty stent
Carotid artery stenosis
Filter protection
Flow reversal system
Ischemic brain lesions
Abstract in English
Objectives: Carotid artery stenting (CAS) has become an alternative treatment for patients presenting symptomatic carotid artery stenosis. The improvement in clinical outcomes with CAS has been associated with the development of embolic protection devices. The trial aim is to compare flow-­reversal versus filter protection during CAS through femoral access. Methods: Patients were randomly enrolled in CAS using flow-­reversal or filter protection. The primary endpoints were the incidence, number and size of new ischemic brain lesions after CAS. The secondary endpoints included major adverse cardiac and cerebrovascular events (MACCE), transient ischemic attack (TIA) and definitive ischemic brain lesions on fluid-­attenuated inversion recovery magnetic resonance image (FLAIR-­MRI) at a three-­month follow-­up. Ischemic brain lesions were assessed by a 3T-­MRI. Neurological outcomes were evaluated by means of the National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS). Results: Forty consecutive patients were randomly assigned. Compared to flow-­reversal (n=21), filter protection (n=19) resulted in a significant reduction in the incidence (15.8% vs. 47.6%, p=0.03), number (0.73 vs. 2.6, p=0.05) and size (0.81 vs. 2.23 mm, p=0.05) of new ischemic brain lesions. Two patients, one from each group, presented TIA at the three-­month follow-­up. There were no MACCE in the hospital or at the three-­month follow-­up. Conclusions: In this small sample size trial, filter protection was more effective than flow-­reversal in reducing ischemic brain lesions during CAS through femoral approach.
 
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