The US AneuRx Clinical Trial: 6-year clinical update 2002

A total of 1193 patients with infrarenal abdominal aortic aneurysms were treated with the AneuRx Stent Graft System at 19 US investigational centers from 1996 to 1999. This report summarizes clinical data collected and analyzed as of August 28, 2002. There have been 10 late (>30 days) aneurysm ruptures, 8 late (>30 days) aneurysm-related deaths, and 38 late (>30 days) surgical conversions, including 8 for rupture. Kaplan-Meier analyses of the primary outcome measures at 4 years indicate the following: a freedom from rupture rate of 98.4%; a freedom from surgical conversion rate of 90.4%; a freedom from aneurysm-related death rate of 96.9%; and a probability of survival rate, based on all-cause mortality, of 62.4%. Secondary outcome measures at 4 years include stent graft patency in 96.4%, endoleak in 13.9%, aneurysm enlargement in 11.5% and stent graft migration in 9.5% of patients. These results provide evidence that the AneuRx Stent Graft System continues to be a safe and effective treatment option for appropriately selected patients with infrarenal abdominal aneurysms.