Christopher Kwolek (Boston, USA) talks to VEITHtv about the “truly revolutionary” LEOPARD trial which evaluated the AFX EVAR AAA Graft System (Endologix) with anatomical fixation against a range of other approved endovascular systems with proximal fixation. The three-year data show that AFX has “absolutely the same” durability, safety and efficacy as other commonly commercially available devices in the US, he says.
Kwolek emphasises that LEOPARD is the only randomised controlled trial (RCT) with contemporary comparative EVAR data and points out that the three-year results showed no difference between AFX2 and other devices, with regard to important outcomes including a composite endpoint (that included periprocedural, death, rupture, conversion to open surgical repair and other events), freedom from aneurysm-related complications, freedom from type I, II and III endoleak and freedom from all-cause and aneurysm-related mortality.
These results are “vitally important” because for the first time this “gives us a contemporary control group for all future EVAR and endovascular device trials designed to treat aneurysms”, adds Kwolek, while he discusses the need to continue pursuing high quality Level 1 evidence to “truly make the best, most informed decisions to benefit our patients”.
This video is sponsored by Endologix.