A multicenter clinical trial on the five-year outcomes following treatment of acute, complicated type B aortic dissection with a conformable stent graft.

Objective: Thoracic endovascular repair (TEVAR) has become the treatment of choice for acute, complicated type B aortic dissections. The purpose of this study was to evaluate the 5-year outcomes of the GORE TAG 08-01 study on TEVAR for acute, complicated type B aortic dissections using the Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG), and to establish if late aortic complications are avoided and remodeling is sustained.

Methods: From January 2010 to February 2017, 50 patients with acute, complicated type B aortic dissections were enrolled from 26 sites in the U.S. in this prospective, non-randomized study. Patients underwent follow-up assessments post-procedure, at 1 month, 6 months, 1 year and then yearly through 5 years. Device-related events, false lumen thrombosis, and aortic remodeling were assessed from computed tomography (CT) scans by a core laboratory.

Results: The all-cause mortality rate through 5 years was 26%. 4% of patients experienced late (> 30 day) deaths that were attributable to aortic pathology. Secondary interventions were required in 22% of patients. In 87% of patients complete false lumen thrombosis in the portion of the false lumen parallel to the stent graft was observed. There was a significant 11 mm increase in maximum true lumen diameter (P < .0001) and a 22 mm decrease in maximum false lumen diameter (P < .0001), over 5 years. True lumen area was also increased, by 221 mm (P = .0003) over 5-years. There was no significant change in false lumen area. There were no associations observed between patient outcomes and pre-treatment indication for treatment (i.e., rupture with or without malperfusion or malperfusion alone).

Conclusions: Treatment of patients with advanced pathophysiology with the CTAG device resulted in favorable long-term clinical and anatomic outcomes. Complete thrombosis of the false lumen and positive aortic remodeling was sustained throughout the study. The low rate of late aortic events observed in this study demonstrates the safety, effectiveness and the long-term durability of the CTAG device.