Talent LPS AAA stent graft: results of a pivotal clinical trial

PURPOSE: We report results of a pivotal prospective clinical trial that compared standard surgical repair with endovascular exclusion of abdominal aortic aneurysm (AAA) with the Talent LPS stent graft system. METHODS: Between March 24, 1999, and September 19, 2000, 240 patients with AAA who underwent stent graft placement and 126 patients who concurrently underwent surgery to treat AAA were enrolled at 17 centers in the United States. All patients were considered to be at low risk from aortic surgery. Patients who underwent endovascular repair received a bifurcated Talent LPS stent graft; surgical control subjects underwent standard operative techniques. Inclusion criteria were AAA larger than 4.0 cm in diameter, with proximal neck > 5 mm long and 14 to 32 mm in diameter, and a 15 mm landing zone in at least one common iliac artery. Access requirements included one external iliac artery of 7 mm caliber or larger. Preoperative anatomic evaluation included computed tomography and angiography. After stent-graft placement, evaluation involved plain radiography and computed tomography performed before discharge and at 1, 6, and 12 months and yearly thereafter. RESULTS: There was no significant difference in early (<30 days) or late mortality between the two groups. Complications were slightly higher in the surgical cohort. The stent graft group did better in terms of procedure duration, requirement for general anesthesia and blood transfusion, and intensive care unit and hospital stay. There were three access or deployment failures. Immediate surgical conversion was necessary in only 1 patient, and late conversion in 5 additional patients. There were no aneurysm ruptures. Endoleak rate detected at CT (core laboratory validated) was 14% at 1 month, 12% at 6 months, and 10% at 12 months. CONCLUSIONS: Compared with surgical control subjects, patients with AAA treated with the Talent LPS stent graft had fewer complications and the same low operative mortality. Likewise, endovascular repair performed better than surgery in the perioperative period, as measured with several key procedural indicators. Long-term follow-up of patients with the stent graft will be essential to assess durability of these early results.