Endologix 5-Year Real-World LEOPARD Trial Data of AFX Endograft Published

April 27, 2023—Endologix LLC announced the online publication of final 5-year results of the LEOPARD randomized controlled trial comparing outcomes of endovascular aneurysm repair using the Endologix AFX endograft system with anatomical fixation versus commercially available endografts with proximal fixation in a real-world population.

The findings showed that there was no significant difference in aneurysm-related outcomes between patients randomized to the two treatment groups, stated the company.

LEOPARD is a prospective, randomized, multicenter trial that enrolled 455 patients across 56 centers in the United States, with 235 patients in the AFX/AFX2 arm and 220 patients in the comparator arm.

The 5-year data were published by Christopher J. Kwolek, MD, et al online in Journal of Vascular Surgery (JVS). In November 2022, Dr. Kwolek presented the findings in a Late-Breaking Clinical Trials session at the VIVA22 conference held by the VIVA Foundation in Las Vegas, Nevada, on October 31 to November 3.

According to Endologix, the study’s primary endpoint was freedom from aneurysm-related complications (ARC), a composite of perioperative death, aneurysm rupture, conversion to open surgical repair, postoperative endoleaks, endograft migration, aneurysm enlargement, endograft limb occlusion, and device- or aneurysm-related reintervention.

As summarized in the company’s press release, freedom from ARC at 5 years was 63.8% in the AFX/AFX2 device cohort versus 55.5% in comparator endografts.

Also, there was no clinically significant difference between the two cohorts in aneurysm-related mortality, all-cause mortality, rupture, secondary interventions, and type I and type III endoleaks.

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 compared to the rate of 31.6% seen with the comparator devices.

“The publication of these final 5-year results in JVS reinforces the performance of our AFX2 endovascular AAA system in the treatment of patients with abdominal aortic aneurysms,” stated Endologix President and CEO Matt Thompson, MD, in the press release. “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.”

Dr. Thompson continued, “Importantly, the comparable performance results from the LEOPARD study between AFX/AFX2 and other endografts align with a recent publication that was authored on behalf of the Society for Vascular Surgery’s Patient Safety Organization and used linked registry claims data.”

Dr. Thompson referred to “Use of linked registry claims data for long term surveillance of devices after endovascular abdominal aortic aneurysm repair: observational surveillance study,” which was published October 25, 2022, by Philip Goodney, MD, et al online in British Medical Journal (2022;379:e071452z).