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

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 noninferior 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

Acknowledgments

None.

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.

Author contributions

Conceptualization: Liqun Jiao, Yanfei Chen

Formal analysis: Yao Feng, Daqiao Guo

Investigation: All authors

Methodology: Yanfei Chen, Yao Feng

Writing - original draft: Yanfei Chen, Yao Feng.

Writing - review & editing: Yabo Huang, Liyong Zhang, Zhen Li, Daqiao Guo, Liqun Jiao

Ethics approval and consent to participate

The study protocol was approved by the ethics committees at each of the five tertiary centers (including Xuanwu Hospital, Capital Medical University [Department of Neurosurgery]; Zhongshan Hospital, Fudan University [Department of Vascular Surgery]; the First Affiliated Hospital of Soochow University [Department of Neurosurgery]; Liaocheng People’s hospital [Department of Neurosurgery]; and the First Affiliated Hospital of Zhengzhou University [Department of Vascular Surgery]) and informed consent was obtained from each patient.

Consent for publication

All images used in this study were anonymized; hence, consent for publication was waived.

Availability of data

The data used in this study will be made available on request to the corresponding authors.

Further disclosure

Trial registration: Chinese Clinical Trial Registry ChiCTR2300075538 (https://www.chictr.org.cn/bin/project/edit?pid=120172).

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