AneuRx stent graft versus open surgical repair of abdominal aortic aneurysms: multicenter prospective clinical trial.

The results of a prospective, nonrandomized, multicenter clinical trial that compared endovascular stent graft exclusion of abdominal aortic aneurysms with open surgical repair are presented. During an 18-month period, 250 patients with infrarenal aneurysms underwent treatment at 12 study sites-190 patients underwent endovascular repair using the Medtronic AneuRx stent graft (Sunnyvale, Calif), and 60 underwent open surgical repair. There was no significant difference in operative mortality rates between the groups. The patients who underwent stent grafting had significant reductions in blood loss, time to extubation, and days in the intensive care unit and in the hospital, with an earlier return to function. The major morbidity rate was reduced from 23% in the surgery group to 12% (P <. 05) in the stent graft group. There was no difference in the combined morbidity/mortality rates between the two groups. Primary technical success at the time of discharge for the patients with stent grafts was 77%, largely as a result of a 21% endoleak rate. At 1 month, the endoleak rate had decreased to 9%. There was no difference in the primary or secondary procedure success rates at 30 days between the surgery and stent graft groups. The primary graft patency rate at 6 months was 98% in the surgery group and 97% in the stent graft group. The aneurysm exclusion rate at 1 month and 6 months was 100% in patients who underwent surgery and 91% in patients who underwent stent grafting. Stent graft migration occurred in three patients and resulted in late endoleaks; each endoleak was corrected by means of endovascular placement of a stent graft extender cuff. There have been no aneurysm ruptures and no surgical conversions to open repair in the stent graft group. Stent graft repair compares favorably with open surgical repair, with a reduced morbidity rate, shortened hospital stays, and satisfactory short term outcomes.