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S31. LATE-BREAKING CLINICAL TRIAL: Early Results Of An International Controlled Trial Of TEVAR

Jon S Matsumura¹, Richard P. Cambria², Michael D. Dake³, Roy K. Greenberg⁴, Randy D Moore⁵, Lars G. Svensson.^4
1Northwestern University Feinberg School of Medicine, Chicago, Ill.; ²Massachusetts General Hospital, Boston, Mass.; ³University of Virginia, Charlottesville, Va.; ⁴Cleveland Clinic Foundation, Cleveland, Ohio; ⁵University of Calgary, Calgary, AB, Canada.

OBJECTIVES: To evaluate the safety and effectiveness of thoracic endovascular aortic repair (TEVAR) in the elective treatment of patients with descending thoracic aortic aneurysms or ulcers.

METHODS: The STARZ-TX2 clinical trial is an international, non-randomized, controlled trial comparing the safety and effectiveness of open surgical repair (control) with TEVAR using the Zenith TX2® TAA Endovascular Graft, a modular system of tubular components constructed of self-expanding stainless steel Z-stents sewn to full-thickness woven polyester fabric. One hundred sixty TEVAR patients and 70 control patients were enrolled at 42 medical centers between March, 2004 and July, 2006.

RESULTS: Seventy-two percent of TEVAR subjects and 60% of controls were male.  Mean age was 72 years for the TEVAR group and 68 years for the control group. Two patients in the TEVAR group did not receive the device due to access concerns. Each study-defined clinical utility measure was markedly superior in the TEVAR group compared to the control group; i.e. intraoperative red blood cell transfusion (TEVAR 3%, control 87%) and days to hospital discharge (TEVAR 5.0±8.6 days, control 21.4±46.8 days). After thirty days, perioperative mortality was lower in the TEVAR group compared to the control group (1.9% vs. 5.7%), and sentinel perioperative major morbidity events were lower in the TEVAR group compared to controls: stroke (2.5% vs. 7.1%), paraplegia (1.3% vs. 5.7%), and renal failure requiring dialysis (1.3% vs. 4.3%). Through thirty days, secondary interventions were performed on three TEVAR patients and three control patients, there were no aneurysm ruptures in either group, and there were no conversions to open repair in the TEVAR group. 

CONCLUSIONS: Preliminary 30-day results of this trial suggest that TEVAR has mortality, major morbidity, and clinical utility that compares favorably to open repair with no ruptures in either group and no conversions in the TEVAR group. Statistical analysis of one year follow-up of the prespecified endpoints with adjudicated clinical and corelab imaging data will be presented in June.