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

Area of Science:

• Cardiovascular Surgery
• Vascular Surgery
• Thoracic Surgery

Background:

• Uncomplicated type B aortic dissections (uTBAD) management balances medical therapy against risks of early thoracic endovascular aortic repair (TEVAR).
• While TEVAR improves aortic morphology, evidence for enhanced overall survival in uTBAD patients is currently lacking.
• Comprehensive data on costs and quality of life impacts of TEVAR for uTBAD are needed for informed treatment decisions.

Purpose of the Study:

• To determine if early TEVAR improves 5-year survival in patients with uncomplicated type B aortic dissections (uTBAD).
• To evaluate the economic impact and quality of life changes associated with early TEVAR versus standard medical therapy in uTBAD.

Main Methods:

• A randomized, open-label, superiority clinical trial involving 23 Nordic sites.
• Patients aged ≥18 with uncomplicated type B aortic dissection (uTBAD) diagnosed within 4 weeks.
• Randomization to standard medical therapy (SMT) or SMT plus TEVAR (performed 2-12 weeks post-symptom onset).

Main Results:

• This section is not yet available as the trial is ongoing.

Conclusions:

• The study aims to provide crucial data on the survival benefit of early TEVAR in uTBAD.
• Findings will inform treatment strategies by offering insights into cost-effectiveness and quality of life.
• The Nordic healthcare model and robust registries support the trial's validity and data integrity.