Five-year results of thoracic endovascular aortic repair with the Zenith TX2
Jon S Matsumura, Germano Melissano, Richard P Cambria, Michael D Dake, Shraddha Mehta, Lars G Svensson, Randy D Moore, Zenith TX2 Clinical Trial Investigators, Jon S Matsumura, Germano Melissano, Richard P Cambria, Michael D Dake, Shraddha Mehta, Lars G Svensson, Randy D Moore, Zenith TX2 Clinical Trial Investigators
Abstract
Background: This trial evaluated thoracic endovascular aortic repair (TEVAR) compared with open surgical repair of descending thoracic aortic aneurysms and large ulcers at 42 international sites. Whereas several studies demonstrate early safety and utility advantages with TEVAR, longer follow-up is important because of concerns about durability of TEVAR.
Methods: This prospective, nonrandomized study enrolled 160 TEVAR patients treated with the Cook Zenith TX2 and 70 open surgical repair patients.
Results: Although follow-up was limited, 5-year mortality rate was similar at 37% for both groups. Aneurysm-related mortality rate was 5.9% with TEVAR compared with 12% with open surgical repair (P = .11). There were no ruptures of the treated aneurysms in either group or open conversions in the TEVAR group. Predefined severe morbidity occurred at a significantly lower rate in TEVAR (21%) compared with open surgical repair (39%; P < .001). Aneurysm growth was seen by core laboratory in 5.9% of patients and endoleak in 5.7% of patients. Secondary intervention rates were similar between TEVAR (8%) and open surgical repair (12%; P = .49) patients.
Conclusions: Five-year results indicate similar all-cause mortality and aneurysm-related mortality with TEVAR compared with open repair. There was a persistent reduction of severe complications with TEVAR. Reinterventions occurred with similar frequency. TEVAR with the TX2 is a safe and effective alternative to open surgical repair for the treatment of anatomically suitable descending thoracic aortic aneurysms and ulcers.
Trial registration: ClinicalTrials.gov NCT00111176.
Copyright © 2014 Society for Vascular Surgery. All rights reserved.
Source: PubMed