Five-year results of the LEOPARD trial of commercially available endografts

Christopher J Kwolek; Kenneth Ouriel; Fred S Stucky; Vikram K Rao; Peter J Pons; Samuel E Wilson; Scott W Kujath

doi:10.1016/j.jvs.2023.04.011

Five-year results of the LEOPARD trial of commercially available endografts

J Vasc Surg. 2023 Aug;78(2):324-332.e2. doi: 10.1016/j.jvs.2023.04.011. Epub 2023 Apr 15.

Authors

Christopher J Kwolek¹, Kenneth Ouriel², Fred S Stucky³, Vikram K Rao⁴, Peter J Pons⁵, Samuel E Wilson⁶, Scott W Kujath⁷

Affiliations

¹ The Vascular Care Group, Wellesley, MA. Electronic address: ckwolek@vascularcaregrp.com.
² NAMSA, New York, NY.
³ Valley Vascular Consultants, Huntsville, AL.
⁴ Northeast Ohio Vascular Associates, Inc., Willoughby, OH.
⁵ Alabama Heart and Vascular Center, Florence, AL.
⁶ University of California Irvine Medical Center, Orange, CA.
⁷ Midwest Aortic and Vascular Institute, North Kansas City, MO.

PMID: 37068528
DOI: 10.1016/j.jvs.2023.04.011

Abstract

Objective: The LEOPARD (Looking at EVAR Outcomes by Primary Analysis of Randomized Data) trial is a randomized controlled trial comparing the outcomes of endovascular aneurysm repair (EVAR) using commercially available devices in a real-world population.

Methods: A prospective, randomized, multi-center trial was performed to compare the anatomically fixated (AF) AFX/AFX2 endograft system (Endologix) with endografts with proximal fixation (PF) (Cook Medical Zenith Flex; Gore Excluder; and Medtronic Endurant II) in patients with infrarenal abdominal aortic aneurysms. The primary endpoint was freedom from aneurysm-related complications (ARCs), a composite endpoint consisting of perioperative death (≤30 days), aneurysm rupture, conversion to open surgical repair, postoperative endoleaks, endograft migration (≥10 mm), aneurysm enlargement (≥5 mm), endograft limb occlusion, and device- or aneurysm-related reintervention.

Results: The study population was 455 patients enrolled at 56 United States centers: 235 patients were treated with AF devices and 220 with PF devices. The primary endpoint supported noninferiority of the AF cohort at 1 year. The 5-year freedom from ARC Kaplan-Meier estimates were 63.8% for AF patients and 55.5% for PF patients (P = .10). Kaplan-Meier estimates for freedom from aneurysm-related mortality were 98.7% and 97.0% in the AF group and 99.5% and 98.5% in the PF group at 1 and 5 years. There was no difference in aneurysm-related mortality, all-cause mortality, rupture, secondary interventions, and type I and type III endoleak between the two cohorts. The type III endoleak rate at 5 years for the AFX cohort was 1.5% and 0.0% for the comparator cohort (P = .11). There was a lower type II endoleak rate in the AF group at 5 years (78.8% vs 68.4%; P = .037). There were zero open surgical conversions (0.0%) in the AF group and four (2.0%) in the PF group.

Conclusions: The 5-year results from the LEOPARD study demonstrated that there was no clinically significant difference in overall aneurysm-related outcomes between patients randomized to the AFX endograft system or commercially available endografts with proximal fixation.

Trial registration: ClinicalTrials.gov NCT02407457.

Keywords: AFX/AFX2 endografts; Anatomical fixation; Endovascular aneurysm repair (EVAR); Randomized controlled trials; proximal fixation.

Publication types

Randomized Controlled Trial
Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Aortic Aneurysm, Abdominal* / complications
Aortic Aneurysm, Abdominal* / diagnostic imaging
Aortic Aneurysm, Abdominal* / surgery
Blood Vessel Prosthesis / adverse effects
Blood Vessel Prosthesis Implantation*
Endoleak / therapy
Endovascular Procedures*
Humans
Prospective Studies
Prosthesis Design
Retrospective Studies
Stents / adverse effects
Treatment Outcome
United States

Associated data

ClinicalTrials.gov/NCT02407457