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

Autor:	Kwolek CJ; The Vascular Care Group, Wellesley, MA. Electronic address: ckwolek@vascularcaregrp.com., Ouriel K; NAMSA, New York, NY., Stucky FS; Valley Vascular Consultants, Huntsville, AL., Rao VK; Northeast Ohio Vascular Associates, Inc., Willoughby, OH., Pons PJ; Alabama Heart and Vascular Center, Florence, AL., Wilson SE; University of California Irvine Medical Center, Orange, CA., Kujath SW; Midwest Aortic and Vascular Institute, North Kansas City, MO.
Jazyk:	angličtina
Zdroj:	Journal of vascular surgery [J Vasc Surg] 2023 Aug; Vol. 78 (2), pp. 324-332.e2. Date of Electronic Publication: 2023 Apr 15.
DOI:	10.1016/j.jvs.2023.04.011
Abstrakt:	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. (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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