Sunday Trial

Summary

This randomized, open-label, observer-blinded, two-armed controlled study addresses the question of whether thoracic endovascular aortic repair (TEVAR) impacts five-year survival among patients with an uncomplicated Stanford type-B aortic dissection (uTBAD). It is investigator-driven, and patients will be randomized to either standard medical therapy (SMT) alone or SMT + subacute TEVAR. The primary outcome is five-year survival, while secondary outcomes include aortic-related mortality, neurological events, quality of life, costs, reinterventions and readmissions. In addition, subgroup analyses based on the extent of aortic treatment will be investigated.

Research Objectives

Primary Objective
To compare the overall survival at five years between subjects treated with SMT or SMT + subacute TEVAR.

Secondary Objectives

  • To compare the risk of aortic-related mortality.

  • To compare the risk of neurological injury, including stroke or paraplegia.

  • To compare the proportion and indication of subjects who underwent an aortic intervention within 5 years due to development of an aortic complication.

  • To compare the number of disease-related readmissions during follow-up. To compare, based on subgroup analyses, whether extent of TEVAR is associated with either improved survival or neurological injury.

  • To compare the associated risk of reinterventions, including those subjects who were initially randomized to SMT and subsequently required an aortic intervention.

  • To compare the associated changes in quality-of-life.

  • To compare the 10-year overall survival and aortic-related mortality.

  • To compare the costs.

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