Scandinavian trial of uncomplicated aortic dissection therapy: study protocol for a randomized controlled trial
Abstract 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,...
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| Format: | Article |
| Language: | English |
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BMC
2023-03-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07255-7 |
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| author | Claudina Rudolph Beate Rikken Lindberg Timothy Resch Kevin Mani Patrick Björkman Elín Hanna Laxdal Henrik Støvring Henriette Margrethe Beck Gunnar Eriksson Jacob Budtz-Lilly |
| author_facet | Claudina Rudolph Beate Rikken Lindberg Timothy Resch Kevin Mani Patrick Björkman Elín Hanna Laxdal Henrik Støvring Henriette Margrethe Beck Gunnar Eriksson Jacob Budtz-Lilly |
| author_sort | Claudina Rudolph |
| collection | DOAJ |
| description | Abstract 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. Trial registration ClinicalTrials.gov NCT05215587. Registered on January 31, 2022. |
| first_indexed | 2024-04-09T21:36:12Z |
| format | Article |
| id | doaj.art-ce3433588efa499a9bb176486fd29a00 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-09T21:36:12Z |
| publishDate | 2023-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-ce3433588efa499a9bb176486fd29a002023-03-26T11:17:14ZengBMCTrials1745-62152023-03-0124111110.1186/s13063-023-07255-7Scandinavian trial of uncomplicated aortic dissection therapy: study protocol for a randomized controlled trialClaudina Rudolph0Beate Rikken Lindberg1Timothy Resch2Kevin Mani3Patrick Björkman4Elín Hanna Laxdal5Henrik Støvring6Henriette Margrethe Beck7Gunnar Eriksson8Jacob Budtz-Lilly9Division of Vascular Surgery, Department of Cardiovascular Surgery, Aarhus University HospitalDepartment of Cardiothoracic Surgery, Oslo University HospitalDepartment of Vascular SurgerySection of Vascular Surgery, Department of Surgical Sciences, University of UppsalaDepartment of Vascular Surgery, Abdominal Center, Helsinki University HospitalDepartment of Vascular Surgery, Landspitali University HospitalDepartment of Public Health, Aarhus UniversityDivision of Vascular Surgery, Department of Cardiovascular Surgery, Aarhus University HospitalDivision of Vascular Surgery, Department of Cardiovascular Surgery, Aarhus University HospitalDivision of Vascular Surgery, Department of Cardiovascular Surgery, Aarhus University HospitalAbstract 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. Trial registration ClinicalTrials.gov NCT05215587. Registered on January 31, 2022.https://doi.org/10.1186/s13063-023-07255-7Aneurysm, DissectingTEVARType BStent graftUncomplicatedAortic dissection |
| spellingShingle | Claudina Rudolph Beate Rikken Lindberg Timothy Resch Kevin Mani Patrick Björkman Elín Hanna Laxdal Henrik Støvring Henriette Margrethe Beck Gunnar Eriksson Jacob Budtz-Lilly Scandinavian trial of uncomplicated aortic dissection therapy: study protocol for a randomized controlled trial Trials Aneurysm, Dissecting TEVAR Type B Stent graft Uncomplicated Aortic dissection |
| title | 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_short | 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 |
| topic | Aneurysm, Dissecting TEVAR Type B Stent graft Uncomplicated Aortic dissection |
| url | https://doi.org/10.1186/s13063-023-07255-7 |
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