5-Year Outcomes of the Dissected Aorta Repair Through Stent (DARTS) Implantation Trial.

Abstract

Background: The Dissected Aorta Repair Through Stent (DARTS) Implantation trial is a prospective clinical trial in patients with acute DeBakey Type I dissection (ADTI). Herein, we report the 5-year outcomes of the DARTS trial.

Methods: The DARTS trial included patients who underwent ADTI repair with the AMDS from March 2017-January 2019. Clinical outcomes were collected in patients for up to 5 years. Significant change in total aortic diameter was considered as >5mm growth/year and the false lumen (FL) was considered patent, partially thrombosed, or completely thrombosed.

Results: Forty-six patients met eligibility criteria and were included in the DARTS trial. Twelve patients (26.1%) passed away before 5-year follow-up, four patients were lost to follow-up and 3 withdrew from the trial. New stroke occurred in 10 patients (21.7%). Rates of new spinal cord ischemia, distal anastomotic new entry tears, and distal stent-induced new entries were 0. Total aortic diameter was stable in the majority of patients over 5 years. FL patency decreased over time up to 5 years with 75-95% FL thrombosis in zones 0-5. Distal FL communications were found to be associated with distal aortic growth, with no other reliable predictors of adverse aortic remodeling identified. Most patients, 37/46 (80%), were free from any aortic procedure and 43/46 (94%) were free from reoperation through 5 years.

Conclusions: The 5-year outcomes of the DARTS trial demonstrate the safety and efficacy of the AMDS. Measures of aortic growth were generally favorable, with the majority of patients experiencing positive aortic remodeling over 5 years.