Contemporary randomized controlled trials in uncomplicated type B aortic dissection: a comparative methodological analysis

Abstract

The management of uncomplicated type B aortic dissection (uTBAD) remains a subject of ongoing debate. While best medical therapy (BMT) has been the conventional approach, thoracic endovascular aortic repair (TEVAR) has been proposed as an alternative due to its potential to promote aortic remodeling and reduce long-term complications. However, conflicting evidence regarding its survival benefits, procedural risks, and long-term durability has limited its widespread adoption. Three contemporary randomized controlled trials, IMPROVE-AD, EARNEST, and SUNDAY, are currently evaluating the role of TEVAR in uTBAD management. IMPROVE-AD, conducted across North America, aims to determine whether TEVAR reduces all-cause mortality and major aortic complications over six years in a cohort of 1,100 patients. The Scandinavian SUNDAY trial focuses on the subacute phase of uTBAD, investigating aortic remodeling, procedural safety, and long-term survival. EARNEST, based in the UK, integrates clinical, anatomical, and economic endpoints, assessing cost-effectiveness alongside patient-reported quality-of-life outcomes. This article provides a comparative analysis of these trials, examining their study designs, inclusion criteria, intervention protocols, and outcome measures. By synthesizing their methodologies and expected findings, this review contextualizes the evolving role of TEVAR in uTBAD and highlights key considerations for future clinical practice. The results of these trials are expected to shape guideline recommendations, refine patient selection criteria, and clarify TEVAR's long-term benefits in uTBAD management.