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, 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.

Keywords: Aneurysm, Dissecting; Aortic dissection; Stent graft; TEVAR; Type B; Uncomplicated.

Fig. 1

SPIRIT figure. EQ-5D-5D, EuroQOL-5D-5L; HADS, Hospital and Anxiety Depression Score; SF-12, 12-item Short-Form Health Survey; SMT, standard medical therapy; TEVAR, thoracic endovascular aortic repair; uTBAD, uncomplicated type B aortic dissection