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The effect of percutaneouS vs. cutdoWn accEss in patients after Endovascular aorTic repair (SWEET): Study protocol for a single-blind, single-center, randomized controlled trial

BACKGROUND: Endovascular abdominal aortic repair (EVAR) and thoracic endovascular aortic repair (TEVAR) have become the first-line treatment for aortic diseases, but current evidence is uncertain regarding whether a percutaneous approach has better outcomes than cutdown access, especially for patien...

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Autores principales: Zhou, Yuhang, Wang, Jiarong, Zhao, Jichun, Yuan, Ding, Weng, Chengxin, Wang, Tiehao, Huang, Bin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9437429/
https://www.ncbi.nlm.nih.gov/pubmed/36061557
http://dx.doi.org/10.3389/fcvm.2022.966251
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author Zhou, Yuhang
Wang, Jiarong
Zhao, Jichun
Yuan, Ding
Weng, Chengxin
Wang, Tiehao
Huang, Bin
author_facet Zhou, Yuhang
Wang, Jiarong
Zhao, Jichun
Yuan, Ding
Weng, Chengxin
Wang, Tiehao
Huang, Bin
author_sort Zhou, Yuhang
collection PubMed
description BACKGROUND: Endovascular abdominal aortic repair (EVAR) and thoracic endovascular aortic repair (TEVAR) have become the first-line treatment for aortic diseases, but current evidence is uncertain regarding whether a percutaneous approach has better outcomes than cutdown access, especially for patient-centered outcomes (PCOs). This study is designed to compare these outcomes of percutaneous access vs. cutdown access after endovascular aortic repair. METHOD: The SWEET study is a randomized, controlled, single-blind, single-center non-inferiority trial with two parallel groups in two cohorts respectively. After eligibility screening, subjects who meet the inclusion criteria will be divided into Cohort EVAR or Cohort TEVAR according to clinic interviews. And then participants in two cohorts will be randomly allocated to either intervention groups receiving percutaneous access endovascular repair or controlled groups receiving cutdown access endovascular repair separately. Primary clinician-reported outcome (ClinRO) is access-related complication, and primary patient-centered outcome (PCO) is time back to normal life. Follow-up will be conducted at 2 weeks, 1 month, 3 months postoperatively. DISCUSSION: The choice of either percutaneous or cutdown access may not greatly affect the success of EVAR or TEVAR procedures, but can influence the quality of life and patient-centered experience. Given the very low evidence for ClinROs and few data for PCOs, comparison of the percutaneous vs. cutdown access EVAR and TEVAR is essential for both patient-centered care and clinical decision making in endovascular aortic repair. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100053161 (registered on 13th November, 2021).
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spelling pubmed-94374292022-09-03 The effect of percutaneouS vs. cutdoWn accEss in patients after Endovascular aorTic repair (SWEET): Study protocol for a single-blind, single-center, randomized controlled trial Zhou, Yuhang Wang, Jiarong Zhao, Jichun Yuan, Ding Weng, Chengxin Wang, Tiehao Huang, Bin Front Cardiovasc Med Cardiovascular Medicine BACKGROUND: Endovascular abdominal aortic repair (EVAR) and thoracic endovascular aortic repair (TEVAR) have become the first-line treatment for aortic diseases, but current evidence is uncertain regarding whether a percutaneous approach has better outcomes than cutdown access, especially for patient-centered outcomes (PCOs). This study is designed to compare these outcomes of percutaneous access vs. cutdown access after endovascular aortic repair. METHOD: The SWEET study is a randomized, controlled, single-blind, single-center non-inferiority trial with two parallel groups in two cohorts respectively. After eligibility screening, subjects who meet the inclusion criteria will be divided into Cohort EVAR or Cohort TEVAR according to clinic interviews. And then participants in two cohorts will be randomly allocated to either intervention groups receiving percutaneous access endovascular repair or controlled groups receiving cutdown access endovascular repair separately. Primary clinician-reported outcome (ClinRO) is access-related complication, and primary patient-centered outcome (PCO) is time back to normal life. Follow-up will be conducted at 2 weeks, 1 month, 3 months postoperatively. DISCUSSION: The choice of either percutaneous or cutdown access may not greatly affect the success of EVAR or TEVAR procedures, but can influence the quality of life and patient-centered experience. Given the very low evidence for ClinROs and few data for PCOs, comparison of the percutaneous vs. cutdown access EVAR and TEVAR is essential for both patient-centered care and clinical decision making in endovascular aortic repair. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100053161 (registered on 13th November, 2021). Frontiers Media S.A. 2022-08-19 /pmc/articles/PMC9437429/ /pubmed/36061557 http://dx.doi.org/10.3389/fcvm.2022.966251 Text en Copyright © 2022 Zhou, Wang, Zhao, Yuan, Weng, Wang and Huang. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Cardiovascular Medicine
Zhou, Yuhang
Wang, Jiarong
Zhao, Jichun
Yuan, Ding
Weng, Chengxin
Wang, Tiehao
Huang, Bin
The effect of percutaneouS vs. cutdoWn accEss in patients after Endovascular aorTic repair (SWEET): Study protocol for a single-blind, single-center, randomized controlled trial
title The effect of percutaneouS vs. cutdoWn accEss in patients after Endovascular aorTic repair (SWEET): Study protocol for a single-blind, single-center, randomized controlled trial
title_full The effect of percutaneouS vs. cutdoWn accEss in patients after Endovascular aorTic repair (SWEET): Study protocol for a single-blind, single-center, randomized controlled trial
title_fullStr The effect of percutaneouS vs. cutdoWn accEss in patients after Endovascular aorTic repair (SWEET): Study protocol for a single-blind, single-center, randomized controlled trial
title_full_unstemmed The effect of percutaneouS vs. cutdoWn accEss in patients after Endovascular aorTic repair (SWEET): Study protocol for a single-blind, single-center, randomized controlled trial
title_short The effect of percutaneouS vs. cutdoWn accEss in patients after Endovascular aorTic repair (SWEET): Study protocol for a single-blind, single-center, randomized controlled trial
title_sort effect of percutaneous vs. cutdown access in patients after endovascular aortic repair (sweet): study protocol for a single-blind, single-center, randomized controlled trial
topic Cardiovascular Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9437429/
https://www.ncbi.nlm.nih.gov/pubmed/36061557
http://dx.doi.org/10.3389/fcvm.2022.966251
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