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

IntroductionEndovascular 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 analysisThe 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 disseminationEthical 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 registrationELITE trial was registered on 27 September 2023 in the Chinese Clinical Trials Registry (ChiCTR2300076236).