Scandinavian trial of uncomplicated aortic dissection therapy : study protocol for a randomized controlled trial
Background Contemporary management of uncomplicated type B aortic dissections (uTBAD) is based on the acuity and various morphological features. Medical therapy is mandatory, while the risks of early thoracic endovascular aortic repair (TEVAR) are balanced against the potential for rupture, complex...
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Uppsala universitet, Kärlkirurgi
2023
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ftuppsalauniv:oai:DiVA.org:uu-500645 2024-02-11T10:05:10+01:00 Scandinavian trial of uncomplicated aortic dissection therapy : study protocol for a randomized controlled trial Rudolph, Claudina Rikken Lindberg, Beate Resch, Timothy Mani, Kevin Björkman, Patrick Laxdal, Elín Hanna Støvring, Henrik Beck, Henriette Margrethe Eriksson, Gunnar Budtz-Lilly, Jacob 2023 application/pdf http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-500645 https://doi.org/10.1186/s13063-023-07255-7 eng eng Uppsala universitet, Kärlkirurgi Aarhus Univ Hosp, Dept Cardiovasc Surg, Div Vasc Surg, Aarhus, Denmark. Natl Hosp Norway, Oslo Univ Hosp, Dept Cardiothorac Surg, Oslo, Norway. Rigshosp, Dept Vasc Surg, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth & Med Sci, Dept Clin Med, Copenhagen, Denmark. Helsinki Univ Hosp, Abdominal Ctr, Dept Vasc Surg, Helsinki, Finland. Landspitali Univ Hosp, Dept Vasc Surg, Reykjavik, Iceland. Aarhus Univ, Dept Publ Hlth, Aarhus, Denmark. Trials, 2023, 24:1, orcid:0000-0002-4224-5351 http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-500645 doi:10.1186/s13063-023-07255-7 PMID 36949478 ISI:000957721400002 info:eu-repo/semantics/openAccess Aneurysm Dissecting TEVAR Type B Stent graft Uncomplicated Aortic dissection Surgery Kirurgi Article in journal info:eu-repo/semantics/article text 2023 ftuppsalauniv https://doi.org/10.1186/s13063-023-07255-7 2024-01-17T23:33:49Z Background Contemporary management of uncomplicated type B aortic dissections (uTBAD) is based on the acuity and various morphological features. Medical therapy is mandatory, while the risks of early thoracic endovascular aortic repair (TEVAR) are balanced against the potential for rupture, complex surgery, and death. Improved aortic morphology following TEVAR is documented, but evidence for improved overall survival is lacking. The costs and impact on quality of life are also needed. Methods The trial is a randomized, open-label, superiority clinical trial with parallel assignment of subjects at 23 clinical sites in Denmark, Norway, Sweden, Finland, and Iceland. Eligibility includes patients aged ≥ 18 with uTBAD of < 4 weeks duration. Recruited subjects will be randomized to either standard medical therapy (SMT) or SMT + TEVAR, where TEVAR must be performed between 2–12 weeks from the onset of symptoms. Discussion This trial will evaluate the primary question of whether early TEVAR improves survival at 5 years among uTBAD patients. Moreover, the costs and the impact on quality of life should provide sorely needed data on other factors that play a role in treatment strategy decisions. The common Nordic healthcare model, with inclusion of all aortic centers, provides a favorable setting for carrying out this trial, while the robust healthcare registries ensure data validity. Article in Journal/Newspaper Iceland Uppsala University: Publications (DiVA) Norway Stent ENVELOPE(156.333,156.333,-81.250,-81.250) Trials 24 1 |
institution |
Open Polar |
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Uppsala University: Publications (DiVA) |
op_collection_id |
ftuppsalauniv |
language |
English |
topic |
Aneurysm Dissecting TEVAR Type B Stent graft Uncomplicated Aortic dissection Surgery Kirurgi |
spellingShingle |
Aneurysm Dissecting TEVAR Type B Stent graft Uncomplicated Aortic dissection Surgery Kirurgi Rudolph, Claudina Rikken Lindberg, Beate Resch, Timothy Mani, Kevin Björkman, Patrick Laxdal, Elín Hanna Støvring, Henrik Beck, Henriette Margrethe Eriksson, Gunnar Budtz-Lilly, Jacob Scandinavian trial of uncomplicated aortic dissection therapy : study protocol for a randomized controlled trial |
topic_facet |
Aneurysm Dissecting TEVAR Type B Stent graft Uncomplicated Aortic dissection Surgery Kirurgi |
description |
Background Contemporary management of uncomplicated type B aortic dissections (uTBAD) is based on the acuity and various morphological features. Medical therapy is mandatory, while the risks of early thoracic endovascular aortic repair (TEVAR) are balanced against the potential for rupture, complex surgery, and death. Improved aortic morphology following TEVAR is documented, but evidence for improved overall survival is lacking. The costs and impact on quality of life are also needed. Methods The trial is a randomized, open-label, superiority clinical trial with parallel assignment of subjects at 23 clinical sites in Denmark, Norway, Sweden, Finland, and Iceland. Eligibility includes patients aged ≥ 18 with uTBAD of < 4 weeks duration. Recruited subjects will be randomized to either standard medical therapy (SMT) or SMT + TEVAR, where TEVAR must be performed between 2–12 weeks from the onset of symptoms. Discussion This trial will evaluate the primary question of whether early TEVAR improves survival at 5 years among uTBAD patients. Moreover, the costs and the impact on quality of life should provide sorely needed data on other factors that play a role in treatment strategy decisions. The common Nordic healthcare model, with inclusion of all aortic centers, provides a favorable setting for carrying out this trial, while the robust healthcare registries ensure data validity. |
format |
Article in Journal/Newspaper |
author |
Rudolph, Claudina Rikken Lindberg, Beate Resch, Timothy Mani, Kevin Björkman, Patrick Laxdal, Elín Hanna Støvring, Henrik Beck, Henriette Margrethe Eriksson, Gunnar Budtz-Lilly, Jacob |
author_facet |
Rudolph, Claudina Rikken Lindberg, Beate Resch, Timothy Mani, Kevin Björkman, Patrick Laxdal, Elín Hanna Støvring, Henrik Beck, Henriette Margrethe Eriksson, Gunnar Budtz-Lilly, Jacob |
author_sort |
Rudolph, Claudina |
title |
Scandinavian trial of uncomplicated aortic dissection therapy : study protocol for a randomized controlled trial |
title_short |
Scandinavian trial of uncomplicated aortic dissection therapy : study protocol for a randomized controlled trial |
title_full |
Scandinavian trial of uncomplicated aortic dissection therapy : study protocol for a randomized controlled trial |
title_fullStr |
Scandinavian trial of uncomplicated aortic dissection therapy : study protocol for a randomized controlled trial |
title_full_unstemmed |
Scandinavian trial of uncomplicated aortic dissection therapy : study protocol for a randomized controlled trial |
title_sort |
scandinavian trial of uncomplicated aortic dissection therapy : study protocol for a randomized controlled trial |
publisher |
Uppsala universitet, Kärlkirurgi |
publishDate |
2023 |
url |
http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-500645 https://doi.org/10.1186/s13063-023-07255-7 |
long_lat |
ENVELOPE(156.333,156.333,-81.250,-81.250) |
geographic |
Norway Stent |
geographic_facet |
Norway Stent |
genre |
Iceland |
genre_facet |
Iceland |
op_relation |
Trials, 2023, 24:1, orcid:0000-0002-4224-5351 http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-500645 doi:10.1186/s13063-023-07255-7 PMID 36949478 ISI:000957721400002 |
op_rights |
info:eu-repo/semantics/openAccess |
op_doi |
https://doi.org/10.1186/s13063-023-07255-7 |
container_title |
Trials |
container_volume |
24 |
container_issue |
1 |
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1790602067130187776 |