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

Rudolph, ClaudinaAarhus Univ Hosp, Dept Cardiovasc Surg, Div Vasc Surg, Aarhus, Denmark. (author)

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

BackgroundContemporary 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.MethodsThe 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.DiscussionThis 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.

Rikken Lindberg, BeateNatl Hosp Norway, Oslo Univ Hosp, Dept Cardiothorac Surg, Oslo, Norway. (author)
Resch, TimothyRigshosp, Dept Vasc Surg, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth & Med Sci, Dept Clin Med, Copenhagen, Denmark. (author)
Mani, Kevin,1975-Uppsala universitet,Kärlkirurgi(Swepub:uu)kevma940 (author)
Björkman, PatrickHelsinki Univ Hosp, Abdominal Ctr, Dept Vasc Surg, Helsinki, Finland. (author)
Laxdal, Elín HannaLandspitali Univ Hosp, Dept Vasc Surg, Reykjavik, Iceland. (author)
Støvring, HenrikAarhus Univ, Dept Publ Hlth, Aarhus, Denmark. (author)
Beck, Henriette MargretheAarhus Univ Hosp, Dept Cardiovasc Surg, Div Vasc Surg, Aarhus, Denmark. (author)
Eriksson, GunnarAarhus Univ Hosp, Dept Cardiovasc Surg, Div Vasc Surg, Aarhus, Denmark. (author)
Budtz-Lilly, JacobAarhus Univ Hosp, Dept Cardiovasc Surg, Div Vasc Surg, Aarhus, Denmark. (author)
Aarhus Univ Hosp, Dept Cardiovasc Surg, Div Vasc Surg, Aarhus, Denmark.Natl Hosp Norway, Oslo Univ Hosp, Dept Cardiothorac Surg, Oslo, Norway. (creator_code:org_t)

By the author/editor: Rudolph, Claudin ...; Rikken Lindberg, ...; Resch, Timothy; Mani, Kevin, 197 ...; Björkman, Patric ...; Laxdal, Elín Han ...; show more...; Støvring, Henrik; Beck, Henriette ...; Eriksson, Gunnar; Budtz-Lilly, Jac ...; show less...

About the subject

MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Surgery

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