Christopher Kwolek (Massachusetts General Hospital and Harvard Medical School, Boston, USA) presented five-year results from the LEOPARD randomised controlled trial (RCT) during a late-breaking clinical trial session at the 2022 Vascular Interventional Advances (VIVA) conference (31 October–3 November, Las Vegas, USA).
LEOPARD was a prospective multicentre trial designed to directly compare the anatomically fixated AFX2 endovascular abdominal aortic aneurysm (AAA) system (Endologix) and the predecessor AFX device, to commercially available endografts with proximal fixation.
The LEOPARD trial enrolled 455 patients across 56 US centres. A total of 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, postoperative endoleaks, endograft migration, aneurysm enlargement, endograft limb occlusion, and device- or aneurysm-related reintervention.
At VIVA 2022, Kwolek reported the following results:
- Freedom from ARC at five years was:
- 63.8% in AFX/AFX2 device cohort
- 55.5% in comparator endografts
- There was no 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 five 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 five years for the AFX2 cohort than the rate of 31.6% seen with the comparator devices
- The study’s results demonstrated no difference in aneurysm-related outcomes between patients randomised to the AFX and AFX2 device cohort or comparator endografts
“I am excited to present the results from the first-ever randomised controlled trial that compares outcomes between four different commercially available endovascular aneurysm repair (EVAR) devices. Randomised controlled trials represent the highest level of clinical evidence in medicine and it is important that we continue to develop the evidence base for EVAR,” said Kwolek.
“We are very proud to have performed the first RCT in this field and we continue to believe that the investment in industry leading clinical evidence is paramount to patient and physician needs. The five-year results of the LEOPARD RCT continue to support the performance of our AFX2 system and its clinical utility in the treatment of patients with AAAs.” said Matt Thompson, Endologix’s president and CEO. “Importantly, the results from the LEOPARD study, and the performance of AFX2 in comparison with other endografts, are concordant with a recent publication using linked registry claims data, that was authored on behalf of the Society for Vascular Surgery Patient Safety Organisation.”
1Use of linked registry claims data for long term surveillance of devices after endovascular abdominal aortic aneurysm repair: observational surveillance study. Goodney, Philip, et al. BMJ 2022;397:e071452