The LEOPARD (Looking at EVAR Outcomes by Primary Analysis of Randomized Data) trial is the first randomized controlled trial (RCT) comparing the outcomes of endovascular aneurysm repair (EVAR) using commercially available devices in a real-world population.
IRVINE, Calif.–(BUSINESS WIRE)–#alto—Endologix LLC, a privately held global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, has announced the online publication of the final five-year results of the LEOPARD Trial in the Journal of Vascular Surgery ( JVS1). The study’s findings showed that there was no significant difference in aneurysm-related outcomes between patients randomized to the AFX endograft system, with anatomical fixation, and commercially available endografts with proximal fixation.
“The publication of these final five-year results in JVS reinforces the performance of our AFX2 Endovascular AAA System in the treatment of patients with abdominal aortic aneurysms,” said Matt Thompson, MD, President and CEO of Endologix. “We are proud to have conducted the first randomized controlled trial comparing commercially available endografts, and we remain committed to providing the highest quality clinical evidence that underpins our life-changing vascular therapies. Importantly, the comparable performance results from the LEOPARD study between AFX/AFX2 and other endografts align with a recent publication2 that was authored on behalf of the Society for Vascular Surgery’s Patient Safety Organization and used linked registry claims data.”
LEOPARD was a prospective, randomized, multi-center trial that 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 included:
Freedom from ARC at 5 years was:
63.8% in AFX/ AFX2 device cohort
55.5% in comparator endografts
There was no clinically 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
1Kwolek CJ, Ouriel K, Stucky FS, et al. Five-Year Results of the LEOPARD Trial of Commercially Available Endografts. Journal of Vascular Surgery. Published online April 2023. doi:10.1016/j.jvs.2023.04.011
2 Use of linked registry claims data for long term surveillance of devices after endovascular abdominal aortic aneurysm repair: observational surveillance study, Goodney, Philip, et al. British Medical Journal, 2022; 397:e071452
Endologix LLC is a California-based, global medical device company dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease. Endologix’s therapeutic portfolio includes a variety of products in various stages of development that are designed to treat diseases that currently have clinically relevant unmet needs. These products are designed to treat a wide spectrum of vascular disease from abdominal aortic aneurysms to lower limb peripheral vascular disease. Endologix’s current commercial EVAR products include the AFX®2 Endovascular AAA System and the ALTO® Abdominal Stent Graft System. On October 1, 2020, Endologix became a private company, wholly owned by Deerfield Management, an investment management firm committed to advancing healthcare through investment, information, and philanthropy. In April 2021, Endologix completed the acquisition of PQ Bypass, Inc., a privately held medical technology company, adding the DETOUR System and TORUS Stent Graft to the Company’s product pipeline. The DETOUR System and the TORUS Stent Graft have not been approved for sale by any regulatory body. The DETOUR System is an investigational device, limited by United States law to investigational use.
The company has offices and manufacturing sites in Irvine and Santa Rosa, California. To learn more about Endologix, please visit https://www.endologix.com/.