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Open Access 01-12-2023 | Aortic Dissection | Study protocol

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

Authors: Claudina Rudolph, Beate Rikken Lindberg, Timothy Resch, Kevin Mani, Patrick Björkman, Elín Hanna Laxdal, Henrik Støvring, Henriette Margrethe Beck, Gunnar Eriksson, Jacob Budtz-Lilly

Published in: Trials | Issue 1/2023

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.

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Title: Scandinavian trial of uncomplicated aortic dissection therapy: study protocol for a randomized controlled trial
Authors: Claudina Rudolph
Beate Rikken Lindberg
Timothy Resch
Kevin Mani
Patrick Björkman
Elín Hanna Laxdal
Henrik Støvring
Henriette Margrethe Beck
Gunnar Eriksson
Jacob Budtz-Lilly
Publication date: 01-12-2023
Publisher: BioMed Central
Keyword: Aortic Dissection
Published in: Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-023-07255-7

Keynote webinar | Spotlight on modern management of frailty

Springer Medicine

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

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on modern management of frailty

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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