Scandinavian trial of uncomplicated aortic dissection therapy: study protocol for a randomized controlled trial

• Published in: Current controlled trials in cardiovascular medicine 2023-03, Vol.24 (1), p.217-217, Article 217
• Main Authors: Rudolph, Claudina, Lindberg, Beate Rikken, Resch, Timothy, Mani, Kevin, Björkman, Patrick, Laxdal, Elín Hanna, Støvring, Henrik, Beck, Henriette Margrethe, Eriksson, Gunnar, Budtz-Lilly, Jacob
• Format: Article
• Language: English
• Subjects: Aneurysm; Aneurysm, Dissecting; Aneurysms; Antihypertensives; Aortic Aneurysm, Thoracic - diagnostic imaging; Aortic Aneurysm, Thoracic - surgery; Aortic dissection; Aortic Dissection - surgery; Blood Vessel Prosthesis Implantation - adverse effects; Care and treatment; Clinical trials; Diagnosis; Dissecting; Dissecting aneurysm; Endovascular Procedures - adverse effects; Heart; Hospitals; Humans; Informed consent; Intervention; Mortality; Paralysis; Quality of Life; Randomized Controlled Trials as Topic; Retrospective Studies; Risk Factors; Stent graft; Stents; Study Protocol; Surgery; TEVAR; Treatment Outcome; Type B; Uncomplicated; Vascular surgery
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-023-07255-7

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. 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