International controlled clinical trial of thoracic endovascular aneurysm repair with the Zenith TX2 endovascular graft: 1-year results

Purpose: This trial evaluated the safety and effectiveness of thoracic endovascular aortic repair (TEVAR) with a contemporary endograft system compared with open surgical repair (open) of descending thoracic aortic aneurysms and large ulcers. Methods: Forty-two international trial sites enrolled 230 subjects with descending thoracic aortic aneurysms or ulcers. The study compared 160 TEVAR subjects treated with the Zenith TX2 Endovascular Graft (William Cook Europe, ApS, Bjaeverskov, Denmark) with 70 open subjects. Subjects were evaluated preprocedure, predischarge, 1, 6, and 12 months, and yearly through 5 years with medical examination, laboratory testing, chest radiographs, and computed tomography scans. Mortality rates, prespecified severe morbidity composite index, major morbidity, clinical utility, aneurysm rupture, and secondary interventions were compared. The TEVAR subjects were evaluated by a core laboratory for device performance, including change in aneurysm size, endoleak, migration, and device integrity. Results: The 30-day survival rate was noninferior (P < .01) for the TEVAR group compared with the open group (98.1% vs 94.3%). The severe morbidity composite index was lower for TEVAR (0.2 +/- 0.7 vs 0.7 +/- 1.2; P <.01). Cumulative major morbidity scores were significantly lower at 30 days for the TEVAR group compared with the open group (1.3 +/- 3.0 vs 2.9 +/- 3.6, P <.01). The TEVAR patients had fewer cardiovascular, pulmonary, and vascular adverse events, although neurologic events were not significantly different. Clinical utility for the TEVAR patients was superior to that of the open patients. No ruptures or conversions occurred in the first year. Reintervention rates were similar in both groups. At 12 months, aneurysm growth was identified in 7.1% (8/112), endoleak in 3.9% (4/103), migration (>10 mm) in 2.8% (3/107), and other device issues were rare. None of the patients with migration experienced endoleak, aneurysm growth, or required a secondary intervention. Conclusions: Thoracic endovascular aortic repair with the TX2 is a safer and effective alternative to open surgical repair for the treatment of anatomically suitable descending thoracic aortic aneurysms and ulcers at 1 year of follow-up. Device performance issues are infrequent, but careful planning and regular follow-up with imaging remain a necessity.