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 LB1: International Pivotal Controlled Clinical Trial of TEVAR with the TX2: Five-year Results

Jon S. Matsumura MD1, Germano Melissano MD2, Richard P. Cambria MD3, Michael D. Dake4, Shraddha Mehta MD5, Lars Svensson MD6
1University of Wisconsin, Madison , WI; 2San Raffaele Hospital, Milan, Italy; 3Massachusetts General Hospital, Boston, MA; 4Stanford University , Palo Alto, CA; 5MED Institute , West Lafayette, IN; 6Cleveland Clinic Foundation, Cleveland, OH.

OBJECTIVES: The Cook Zenith TX2® Endovascular Graft trial evaluated the safety and effectiveness of thoracic endovascular aortic repair (TEVAR) compared to open surgical repair (Open) of descending thoracic aortic aneurysms and large ulcers at 42 international sites. Study design, pre-specified severe morbidity composite index, major morbidity, clinical utility up to one year have been published and demonstrate early safety and utility advantages with TEVAR. Longer follow up is important because of concerns about durability of TEVAR.

METHODS: One hundred and sixty TEVAR patients were treated with the TX2 and compared to 70 Open patients.
Patients were evaluated yearly with examination, lab testing, and radiographic evaluation. Five year survival, aneurysm related mortality, aneurysm rupture, and secondary interventions were compared. Imaging from TEVAR patients were evaluated by a corelab for device performance: change in aneurysm size, endoleak, migration, and device integrity.

RESULTS: Five year clinical follow up is 88% complete and CT follow up is 87% of eligible patients at this interim analysis. TEVAR patients were four years older at enrollment, yet survival rate was similar at 63% + 4% with TEVAR and 63% + 8% with Open. Aneurysm-related mortality rate is 11% + 3% with TEVAR compared to 23% + 7% with Open. There were no thoracic aneurysm ruptures or open conversions. At 5 years, aneurysm growth (>5 mm) is 7.3% (3/41), endoleak is 5.8% (3/52), migration is 1.6% (1/63), and device integrity issues seen in 6.2% (4/65). At least one reintervention occurred in 6.9% (11/160) of TEVAR patients and 8.6% (6/70) of Open patients. 

CONCLUSIONS: Survival and aneurysm related mortality are similar at five years after TEVAR and Open. Reinterventions after TEVAR and Open occur 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.

AUTHOR DISCLOSURES: J. Matsumura, Research Grants: Abbott, Cook, EV3, W.L. Gore, Endologix; G. Melissano, Nothing to disclose; R. Cambria, Research Grants: Cook, W.L. Gore, Medtronic; M. Dake, Consulting Fees or Other Remuneration (Payment): W.L. Gore, Abbott, Medtronic, AngioDynamics, EV3; S. Mehta, Employment (Full or Part-time):MED Institute, a Cook Group Company; L. Svensson, Honorarium: Edwards, Medtronic

Updated May 2012

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