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ORIGINAL RESEARCH ARTICLE

A prospective multicenter, randomized controlled, non-inferiority trial of bovine pericardial versus polyurethane patching in carotid endarterectomy

Yanfei Chen1† ,  Yao Feng2† ,  Xiao Tang3 ,  Yabo Huang4 ,  Peng Zhou4 ,  Liyong Zhang5 ,  Jiheng Hao5 ,  Zhen Li6 ,  Zhaohui Hua6 ,  Daqiao Gao3* ,  Liqun Jiao1*
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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
Brain & Heart, 4568 https://doi.org/10.36922/bh.4568
Submitted: 18 August 2024 | Revised: 16 November 2024 | Accepted: 19 December 2024 | Published: 7 January 2025
© 2025 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/ )
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Abstract

Carotid endarterectomy (CEA) is the first-line treatment for internal carotid artery stenosis that can lead to stroke. This study aimed to compare the incidence of early adverse clinical events and restenosis between patient groups receiving the newly developed bovine pericardial (BP) and polyurethane patches during CEA. We conducted a multicenter, randomized, non-inferiority trial at five tertiary centers in China. Participants were assigned to either the BP patch or polyurethane patch group. The primary outcome was freedom from restenosis at 1 year after surgery. Restenosis was defined as a narrowing of >50% in the target artery on duplex ultrasound or computed tomography angiography examination. The total number of participants was 120, including 60 each randomized to the BP patch and polyurethane patch groups. Demographics were similar in both groups. Death or significant disability 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: two in the BP patch group (n = 57) and one in the polyurethane patch group (n = 55). There was no significant statistical difference in restenosis, morbidity, or mortality between the two groups (p > 0.4), indicating that the BP patch was non-inferior to the polyurethane patch (p = 0.013 for the full analysis set; p = 0.016 for the per-protocol set). The two groups of patches had similar safety and effectiveness, and the BP patch was non-inferior to the mature polyurethane patch available on the market.

Keywords
Carotid artery stenosis
Carotid endarterectomy
Bovine pericardial patch
Randomized controlled trial
Funding
The trial BP patches were provided free of charge for the trial by Beijing Balance Medical Technology Co., Ltd., China, which was the sponsor of this trial but had no role in design, conduct, and report of the trial.
Conflict of interest
The authors declare that they have no competing interests.
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