Endologix has announced positive interim results from the LEOPARD (Looking at EVAR outcomes by primary analysis of randomised data) clinical study. LEOPARD is the first and only head-to-head, prospective, multicentre, randomised clinical study comparing currently available endovascular abdominal aortic stent grafts. LEOPARD directly compares the Endologix AFX and AFX2 endografts to other commercially available bifurcated aortic endografts.
LEOPARD was initiated in 2015 and has since randomised 458 patients. The primary endpoint in the study is freedom from aneurysm-related complications such as aneurysm rupture, conversion to open repair, endoleaks, migration, aneurysm enlargement and secondary interventions. Based on the patients that have completed their one-year follow-up, freedom from aneurysm-related complications with AFX/AFX2 is 84.7%, compared to 82% with the other devices. These preliminary results demonstrate similar outcomes between the endografts under investigation, but there is a trend towards better performance for AFX/AFX2, which is the only device that preserves the patient’s aortic bifurcation. Based upon the anticipated number of additional patients required to prove superiority, Endologix plans to stop further randomisation in the LEOPARD study and continue to follow enrolled patients for the planned five years.
“The results from this analysis are very encouraging. In particular, we are pleased with the trend towards lower rates of endoleaks, limb occlusions and secondary interventions with AFX/AFX2, along with the absence of type 3 endoleaks,” commented John McDermott, Endologix’s chief executive officer. “We would like to thank our investigators for participating in this important clinical study and look forward to presenting the final one-year results next year after all patients have completed their follow-up.”