Safety and efficacy of drug-eluting stents versus heparin-bonded stents in treatment of femoropopliteal peripheral artery disease: study protocol for a multicentre, prospective randomised controlled trial in China (ELITE trial)

Abstract

Introduction Endovascular therapy has emerged as a prominent strategy for managing femoropopliteal peripheral artery disease, offering acceptable safety and efficacy compared with open surgical bypass. Both paclitaxel-eluting stents and heparin-bonded covered stents have exhibited enhanced clinical outcomes compared with bare metal stents. However, there is currently a lack of level I evidence comparing the safety and efficacy of paclitaxel-eluting stents and heparin-bonded covered stents. Therefore, the primary objective of this study is to systematically evaluate the efficacy and safety outcomes of these two types of stents.Methods and analysis The ELITE trial is a prospective, multicentre, parallel, randomised controlled trial. A total of 450 patients will be recruited. The primary endpoints of the study include primary patency at 1 year post-index procedure.Ethics and dissemination Ethical approval for this study was obtained from the Ethics Committee of West China Hospital of Sichuan University (approval number: 2023–1186). The results will be submitted to a major clinical journal for peer review and publication.Trial registration ELITE trial was registered on 27 September 2023 in the Chinese Clinical Trials Registry (ChiCTR2300076236).