Endologix Announces Interim Results From LEOPARD Study
August 29, 2017—Endologix recently announced interim results from the LEOPARD clinical study. LEOPARD is a head-to-head, prospective, multicenter, randomized clinical study comparing Endologix's AFX and AFX2 endografts to other commercially available endovascular bifurcated aortic abdominal aortic stent grafts.
The trial has randomized 458 patients since enrollment was initiated in 2015. The preliminary results are for 246 patients who have reached 1-year follow-up.
According to Endologix, the interim data demonstrated similar outcomes between the endografts under investigation, but there is a trend toward better performance for AFX and AFX2, which are designed to preserve the aortic bifurcation. The analysis demonstrated a trend toward lower rates of endoleaks, limb occlusions, and secondary interventions with AFX/AFX2, along with the absence of type III endoleaks. The company expects to present the final 1-year results in 2018, after all patients have completed follow-up.
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 who have completed 1-year follow-up, freedom from aneurysm-related complications with AFX/AFX2 is 84.7% compared to 82% with the other devices.
With the anticipated number of additional patients required to prove superiority, Endologix plans to stop further randomization in the LEOPARD study and continue to follow enrolled patients for the planned 5 years, advised the company.