Endologix LLC announced the five-year results from the LEOPARD randomized controlled trial. LEOPARD was a prospective multi-center trial designed to directly compare the anatomically fixated AFX 2 Endovascular AAA System and the predecessor AFX device, to commercially available endografts with proximal fixation. The final five-year results from the LEOPARD study were presented during a Late-Breaking Clinical Trial Session at the 2022 VIVA Conference by the study's principal investigator, Christopher J. Kwolek, MD, M.B.A., F.A.C.S., D.F.S.V.S., Chief Medical Officer, The Vascular Care Group /Mangrove Management Partners.

The LEOPARD trial enrolled 455 patients across 56 US Centers. 235 patients were included in the AFX/AFX2 arm and 220 patients in the comparator arm. The primary endpoint was freedom from aneurysm-related complications (ARC), a composite endpoint consisting of perioperative death, aneurysm rupture, conversion to open surgical repair, post-operative endoleaks, endograft migration, aneurysm enlargement, endograft limb occlusion, and device- or aneurysm-related reintervention.

The results presented are listed below: Freedom from ARC at 5 years was: 63.8% in AFX/AFX2 device cohort 55.5% in comparator endografts There was no significant difference in aneurysm-related mortality, all-cause mortality, rupture, secondary interventions, and Type I and Type III endoleaks between the two cohorts The Type III endoleak rate for the AFX/AFX2 device cohort was 1.5% at 5 years and was not statistically different from the comparator devices The Type II endoleak rate reached a statistically significant lower rate at 21.2% at 5 years for the AFX2 cohort than the rate of 31.6% seen with the comparator devices The study's results demonstrated no difference in aneurysm-related outcomes between patients randomized to the AFX and AFX2 device cohort or comparator endografts.