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Brain & Heart

ORIGINAL RESEARCH ARTICLE
A prospective multicenter, randomized

controlled, non-inferiority trial of bovine
pericardial versus polyurethane patching in

carotid endarterectomy

4
3
4
Yanfei Chen , Yao Feng 2† , Xiao Tang , Yabo Huang , Peng Zhou ,
1†
6
Liyong Zhang 5 , Jiheng Hao 5 , Zhen Li , Zhaohui Hua , Daqiao Guo *,
6
3
1
and Liqun Jiao *
1 Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China
2 Department of Neurology, Fuwai Hospital, National Center for Cardiovascular Diseases,
Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China
3 Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China
4 Department of Neurosurgery and Brain and Nerve Research Laboratory, The First Affiliated Hospital
of Soochow University, Soochow University, Suzhou, China
5 Department of Neurosurgery, Liaocheng People’s Hospital, Liaocheng, China
6 Department of Endovascular Surgery, The First Affiliated Hospital of Zhengzhou University,
Zhengzhou, China
† These authors contributed equally
to this work.
*Corresponding authors:
Liqun Jiao Abstract
(liqunjiao@sina.cn)
Daqiao Guo Carotid endarterectomy (CEA) is the first-line treatment for internal carotid artery
(guo.daqiao@zs-hospital.sh.cn) stenosis that can lead to stroke. This study aimed to compare the incidence of
Citation: Chen Y, Feng Y, Tang X, early adverse clinical events and restenosis between patient groups receiving the
et al. A prospective multicenter, newly developed bovine pericardial (BP) and polyurethane patches during CEA. We
randomized controlled, non-
inferiority trial of bovine pericardial conducted a multicenter, randomized, non-inferiority trial at five tertiary centers in
versus polyurethane patching in China. Participants were assigned to either the BP patch or polyurethane patch group.
carotid endarterectomy. Brain & The primary outcome was freedom from restenosis at 1 year after surgery. Restenosis
Heart. 2025;3(1):4568.
doi: 10.36922/bh.4568 was defined as a narrowing of >50% in the target artery on duplex ultrasound or
computed tomography angiography examination. The total number of participants
Submitted: August 18, 2024 was 120, including 60 each randomized to the BP patch and polyurethane patch
Revised: November 16, 2024 groups. Demographics were similar in both groups. Death or significant disability
Accepted: December 19, 2024 was comparable between the two groups (3:1, p = 0.619) during the perioperative
period. At the 12-month assessment (n = 112), three patients had severe restenosis:
Published online: January 7, 2025 two in the BP patch group (n = 57) and one in the polyurethane patch group
Copyright: © 2025 Author(s). (n = 55). There was no significant statistical difference in restenosis, morbidity, or
This is an Open Access article mortality between the two groups (p > 0.4), indicating that the BP patch was non-
distributed under the terms of the
Creative Commons Attribution inferior to the polyurethane patch (p = 0.013 for the full analysis set; p = 0.016 for the
License, permitting distribution, per-protocol set). The two groups of patches had similar safety and effectiveness,
and reproduction in any medium, and the BP patch was non-inferior to the mature polyurethane patch available on
provided the original work is
properly cited. the market.
Publisher’s Note: AccScience
Publishing remains neutral with Keywords: Carotid artery stenosis; Carotid endarterectomy; Bovine pericardial patch;
regard to jurisdictional claims in
published maps and institutional Randomized controlled trial
affiliations.

Volume 3 Issue 1 (2025) 1 doi: 10.36922/bh.4568