An Observational Registry of Carotid Endarterectomy and Carotid Artery Stenting in Brazil: Study Protocol

Detalhes bibliográficos
Autor(a) principal: Joviliano, Edwaldo Edner
Data de Publicação: 2016
Outros Autores: Yoshida, Winston Bonetti [UNESP], Sobreira, Marcone Lima [UNESP], Moura, Regina [UNESP], Guillaumon, Ana Terezinha, De Oliveira Raymundo, Selma Regina, Miquelin, Daniel Gustavo, Hafner, Ludvig, Almeida, Marcelo Jose
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UNESP
Texto Completo: http://dx.doi.org/10.2196/resprot.5986
http://hdl.handle.net/11449/165422
Resumo: Background: Carotid artery stenting (CAS) and carotid endarterectomy (CEA) are alternative strategies for stroke prevention in patients with atherosclerotic carotid disease. CEA has been considered the first-line treatment for carotid stenosis worldwide, and the safety and efficacy of CAS compared to CEA remains in question. Objective: The purpose of this study is to compare the practice and outcomes of CAS and CEA in a real-world setting within public university hospitals in Brazil. Methods: This study will be a prospective 5-year analysis of treatment for atherosclerotic carotid stenosis with CEA and CAS performed at 5 centers affiliated with the Vascular Study Group at public university hospitals in Brazil. The indications for the procedures will be determined by each surgeon's individual discretion, in accordance with preoperative risk evaluation. The primary outcome measures will be (1) any in-hospital stroke or death, and (2) any per-procedural stroke, death, or myocardial infarction (MI). Patients undergoing CEA in conjunction with cardiac surgery will be excluded from the study. Multivariate logistic regression will be performed to identify predictors of stroke or death in patients undergoing CEA and CAS. All tests of significance will be performed at the .05 level. This study was approved by the Committee of Ethics in Research at the University Hospital of Ribeirao Preto Medical School, and in all other participating institutions linked to National Research System and National Board of Health in Brazil (Process 15695/2011). Results: This study is currently in the recruitment phase, and the final patient is expected to be enrolled by the end of 2018. We hope to recruit approximately 800 patients to the study. Analyses will focus on primary end points for patients that are allocated to each treatment group. During the per-procedural period, the occurrence of the primary end point components (stroke, MI, or death) for CAS and CEA will be analyzed for symptomatic or asymptomatic subjects. Conclusions: The analyses of the primary endpoints (and all others variables of the study) are expected to be published in 2019 in a peer reviewed journal, and results will be presented at scientific meetings, with summary results published online. This study will obtain new data related to the quality of treatment for carotid disease in Brazil at the primary training centers of future vascular surgeons, but the initial data that will be obtained and published (with the outcomes and complications) are restricted to the first 30 days postprocedure. This time restriction limits the comparison of the results that relate to the main goal of treatment, which is to decrease the risk of stroke over 5 years. The purpose of the study group is to continue the monitoring of patient records, and evaluate the follow-up data in the 5 years following the initial evaluation. This study protocol will contribute very significantly to improving the care of patients with carotid disease, in addition to qualifying the level of assistance provided in public university hospitals in the state of Sao Paulo, Brazil.
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spelling An Observational Registry of Carotid Endarterectomy and Carotid Artery Stenting in Brazil: Study Protocolcarotid artery diseasescarotid endarterectomycarotid stenosiscarotid stentingmedical record linkageBackground: Carotid artery stenting (CAS) and carotid endarterectomy (CEA) are alternative strategies for stroke prevention in patients with atherosclerotic carotid disease. CEA has been considered the first-line treatment for carotid stenosis worldwide, and the safety and efficacy of CAS compared to CEA remains in question. Objective: The purpose of this study is to compare the practice and outcomes of CAS and CEA in a real-world setting within public university hospitals in Brazil. Methods: This study will be a prospective 5-year analysis of treatment for atherosclerotic carotid stenosis with CEA and CAS performed at 5 centers affiliated with the Vascular Study Group at public university hospitals in Brazil. The indications for the procedures will be determined by each surgeon's individual discretion, in accordance with preoperative risk evaluation. The primary outcome measures will be (1) any in-hospital stroke or death, and (2) any per-procedural stroke, death, or myocardial infarction (MI). Patients undergoing CEA in conjunction with cardiac surgery will be excluded from the study. Multivariate logistic regression will be performed to identify predictors of stroke or death in patients undergoing CEA and CAS. All tests of significance will be performed at the .05 level. This study was approved by the Committee of Ethics in Research at the University Hospital of Ribeirao Preto Medical School, and in all other participating institutions linked to National Research System and National Board of Health in Brazil (Process 15695/2011). Results: This study is currently in the recruitment phase, and the final patient is expected to be enrolled by the end of 2018. We hope to recruit approximately 800 patients to the study. Analyses will focus on primary end points for patients that are allocated to each treatment group. During the per-procedural period, the occurrence of the primary end point components (stroke, MI, or death) for CAS and CEA will be analyzed for symptomatic or asymptomatic subjects. Conclusions: The analyses of the primary endpoints (and all others variables of the study) are expected to be published in 2019 in a peer reviewed journal, and results will be presented at scientific meetings, with summary results published online. This study will obtain new data related to the quality of treatment for carotid disease in Brazil at the primary training centers of future vascular surgeons, but the initial data that will be obtained and published (with the outcomes and complications) are restricted to the first 30 days postprocedure. This time restriction limits the comparison of the results that relate to the main goal of treatment, which is to decrease the risk of stroke over 5 years. The purpose of the study group is to continue the monitoring of patient records, and evaluate the follow-up data in the 5 years following the initial evaluation. This study protocol will contribute very significantly to improving the care of patients with carotid disease, in addition to qualifying the level of assistance provided in public university hospitals in the state of Sao Paulo, Brazil.Fundacao de Apoio ao Ensino, Pesquisa e Assistencia do Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao PauloUniv Sao Paulo, Ribeirao Preto Med Sch, Dept Surg & Anat, Ave Bandeirantes 3900, BR-14048900 Ribeirao Preto, BrazilUniv Julio de Mesquita Filho UNESP, Botucatu Med Sch, Dept Surg, Botucatu, SP, BrazilUniv Estadual Campinas, Sch Med Sci, Dept Surg, Campinas, SP, BrazilSao Jose do Rio Preto Med Sch FAMERP, Dept Surg, Sao Jose Do Rio Preto, BrazilMarilia Med Sch FAMEMA, Dept Surg, Marilia, BrazilUniv Julio de Mesquita Filho UNESP, Botucatu Med Sch, Dept Surg, Botucatu, SP, BrazilJmir Publications, IncUniversidade de São Paulo (USP)Universidade Estadual Paulista (Unesp)Universidade Estadual de Campinas (UNICAMP)Marilia Med Sch FAMEMAJoviliano, Edwaldo EdnerYoshida, Winston Bonetti [UNESP]Sobreira, Marcone Lima [UNESP]Moura, Regina [UNESP]Guillaumon, Ana TerezinhaDe Oliveira Raymundo, Selma ReginaMiquelin, Daniel GustavoHafner, LudvigAlmeida, Marcelo Jose2018-11-28T01:49:52Z2018-11-28T01:49:52Z2016-10-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article6application/pdfhttp://dx.doi.org/10.2196/resprot.5986Jmir Research Protocols. Toronto: Jmir Publications, Inc, v. 5, n. 4, 6 p., 2016.1929-0748http://hdl.handle.net/11449/16542210.2196/resprot.5986WOS:000391042300042WOS000391042300042.pdf9609324832591382Web of Sciencereponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengJmir Research Protocolsinfo:eu-repo/semantics/openAccess2024-08-14T14:19:45Zoai:repositorio.unesp.br:11449/165422Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-14T14:19:45Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false
dc.title.none.fl_str_mv An Observational Registry of Carotid Endarterectomy and Carotid Artery Stenting in Brazil: Study Protocol
title An Observational Registry of Carotid Endarterectomy and Carotid Artery Stenting in Brazil: Study Protocol
spellingShingle An Observational Registry of Carotid Endarterectomy and Carotid Artery Stenting in Brazil: Study Protocol
Joviliano, Edwaldo Edner
carotid artery diseases
carotid endarterectomy
carotid stenosis
carotid stenting
medical record linkage
title_short An Observational Registry of Carotid Endarterectomy and Carotid Artery Stenting in Brazil: Study Protocol
title_full An Observational Registry of Carotid Endarterectomy and Carotid Artery Stenting in Brazil: Study Protocol
title_fullStr An Observational Registry of Carotid Endarterectomy and Carotid Artery Stenting in Brazil: Study Protocol
title_full_unstemmed An Observational Registry of Carotid Endarterectomy and Carotid Artery Stenting in Brazil: Study Protocol
title_sort An Observational Registry of Carotid Endarterectomy and Carotid Artery Stenting in Brazil: Study Protocol
author Joviliano, Edwaldo Edner
author_facet Joviliano, Edwaldo Edner
Yoshida, Winston Bonetti [UNESP]
Sobreira, Marcone Lima [UNESP]
Moura, Regina [UNESP]
Guillaumon, Ana Terezinha
De Oliveira Raymundo, Selma Regina
Miquelin, Daniel Gustavo
Hafner, Ludvig
Almeida, Marcelo Jose
author_role author
author2 Yoshida, Winston Bonetti [UNESP]
Sobreira, Marcone Lima [UNESP]
Moura, Regina [UNESP]
Guillaumon, Ana Terezinha
De Oliveira Raymundo, Selma Regina
Miquelin, Daniel Gustavo
Hafner, Ludvig
Almeida, Marcelo Jose
author2_role author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universidade de São Paulo (USP)
Universidade Estadual Paulista (Unesp)
Universidade Estadual de Campinas (UNICAMP)
Marilia Med Sch FAMEMA
dc.contributor.author.fl_str_mv Joviliano, Edwaldo Edner
Yoshida, Winston Bonetti [UNESP]
Sobreira, Marcone Lima [UNESP]
Moura, Regina [UNESP]
Guillaumon, Ana Terezinha
De Oliveira Raymundo, Selma Regina
Miquelin, Daniel Gustavo
Hafner, Ludvig
Almeida, Marcelo Jose
dc.subject.por.fl_str_mv carotid artery diseases
carotid endarterectomy
carotid stenosis
carotid stenting
medical record linkage
topic carotid artery diseases
carotid endarterectomy
carotid stenosis
carotid stenting
medical record linkage
description Background: Carotid artery stenting (CAS) and carotid endarterectomy (CEA) are alternative strategies for stroke prevention in patients with atherosclerotic carotid disease. CEA has been considered the first-line treatment for carotid stenosis worldwide, and the safety and efficacy of CAS compared to CEA remains in question. Objective: The purpose of this study is to compare the practice and outcomes of CAS and CEA in a real-world setting within public university hospitals in Brazil. Methods: This study will be a prospective 5-year analysis of treatment for atherosclerotic carotid stenosis with CEA and CAS performed at 5 centers affiliated with the Vascular Study Group at public university hospitals in Brazil. The indications for the procedures will be determined by each surgeon's individual discretion, in accordance with preoperative risk evaluation. The primary outcome measures will be (1) any in-hospital stroke or death, and (2) any per-procedural stroke, death, or myocardial infarction (MI). Patients undergoing CEA in conjunction with cardiac surgery will be excluded from the study. Multivariate logistic regression will be performed to identify predictors of stroke or death in patients undergoing CEA and CAS. All tests of significance will be performed at the .05 level. This study was approved by the Committee of Ethics in Research at the University Hospital of Ribeirao Preto Medical School, and in all other participating institutions linked to National Research System and National Board of Health in Brazil (Process 15695/2011). Results: This study is currently in the recruitment phase, and the final patient is expected to be enrolled by the end of 2018. We hope to recruit approximately 800 patients to the study. Analyses will focus on primary end points for patients that are allocated to each treatment group. During the per-procedural period, the occurrence of the primary end point components (stroke, MI, or death) for CAS and CEA will be analyzed for symptomatic or asymptomatic subjects. Conclusions: The analyses of the primary endpoints (and all others variables of the study) are expected to be published in 2019 in a peer reviewed journal, and results will be presented at scientific meetings, with summary results published online. This study will obtain new data related to the quality of treatment for carotid disease in Brazil at the primary training centers of future vascular surgeons, but the initial data that will be obtained and published (with the outcomes and complications) are restricted to the first 30 days postprocedure. This time restriction limits the comparison of the results that relate to the main goal of treatment, which is to decrease the risk of stroke over 5 years. The purpose of the study group is to continue the monitoring of patient records, and evaluate the follow-up data in the 5 years following the initial evaluation. This study protocol will contribute very significantly to improving the care of patients with carotid disease, in addition to qualifying the level of assistance provided in public university hospitals in the state of Sao Paulo, Brazil.
publishDate 2016
dc.date.none.fl_str_mv 2016-10-01
2018-11-28T01:49:52Z
2018-11-28T01:49:52Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://dx.doi.org/10.2196/resprot.5986
Jmir Research Protocols. Toronto: Jmir Publications, Inc, v. 5, n. 4, 6 p., 2016.
1929-0748
http://hdl.handle.net/11449/165422
10.2196/resprot.5986
WOS:000391042300042
WOS000391042300042.pdf
9609324832591382
url http://dx.doi.org/10.2196/resprot.5986
http://hdl.handle.net/11449/165422
identifier_str_mv Jmir Research Protocols. Toronto: Jmir Publications, Inc, v. 5, n. 4, 6 p., 2016.
1929-0748
10.2196/resprot.5986
WOS:000391042300042
WOS000391042300042.pdf
9609324832591382
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Jmir Research Protocols
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 6
application/pdf
dc.publisher.none.fl_str_mv Jmir Publications, Inc
publisher.none.fl_str_mv Jmir Publications, Inc
dc.source.none.fl_str_mv Web of Science
reponame:Repositório Institucional da UNESP
instname:Universidade Estadual Paulista (UNESP)
instacron:UNESP
instname_str Universidade Estadual Paulista (UNESP)
instacron_str UNESP
institution UNESP
reponame_str Repositório Institucional da UNESP
collection Repositório Institucional da UNESP
repository.name.fl_str_mv Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)
repository.mail.fl_str_mv
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