Indications and outcomes of AneuRx phase III trial versus use of commercial AneuRx stent graft

Objective: Approval by the United States Food and Drug Administration of endoluminal repair of abdominal aortic aneurysm (AAA) with the AneuRx stent graft was based on the outcome of a multicenter trial in which patients met strict inclusion and exclusion criteria. Since widespread use of the commercially available graft, little information is available as to whether indications and outcomes have evolved. We examined this important issue at our institution. Methods: Data concerning indications, repair, and follow-up for all patients undergoing endoluminal repair of AAA was prospectively entered into a patient registry. Group 1 comprised consecutive patients enrolled in the AneuRx Phase III clinical trial between November 1998 and September 2000. Group 2 consisted of consecutive patients who underwent implantation of the commercially available AneuRx graft between May 1999 and June 2001. Results: Group 1 included 42 patients (mean age, 72 years), and group 2 included 54 patients (mean age, 73 years). Patient demographics and risk factors were similar between the two groups. Maximum aortic aneurysm diameter was significantly greater (P = .021) in group 1 (55 mm ± 10.9 [SD] mm) compared with group 2 (52 ± 15.6 mm). Maximum infrarenal aortic neck length was significantly longer (P = .022) in group 1 (30 ± 11.7 mm) than in group 2 (23 ± 12.0 mm). Maximum left common iliac artery diameter in group 1 (13.0 ± 3.2 mm) was significantly smaller (P = .032) than that in group 2 (14 ± 6.5 mm). During follow-up, no differences were observed for number of endoleaks, subsequent interventions, or graft explantation between the two groups. Conclusions: In group 2 patients AAAs were significantly smaller, infrarenal aortic neck length was shorter, and left common iliac arteries were larger. Common iliac artery ectasia and aneurysmal disease has become another indication for use of the AneuRx commercial graft at our institution, with no significant differences in intermediate outcome. Given the possibility for evolving indications compared with trial inclusion and exclusion criteria, institutions that use the AneuRx commercial graft should prospectively monitor outcomes for quality assurance.