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Two-year results of the randomized DISCOVER trial comparing covered versus bare-metal stents in the common iliac artery

Published:November 03, 2022DOI:https://doi.org/10.1016/j.ejvs.2022.11.008
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      Abstract

      Introduction

      It has been suggested that covered stents may lower restenosis rates compared with bare-metal stents after endovascular treatment of the common iliac artery. The aim of this trial was to provide additional evidence on the efficacy of covered versus bare-metal stents in the common iliac artery.

      Methods

      We performed a multicenter, randomized, single-blind controlled superiority trial comparing covered and bare-metal balloon-expandable stents for advanced atherosclerotic lesions in the common iliac artery. This was defined as stenosis longer than 3 cm, or occlusion. The primary end point was freedom from binary restenosis after 2 years of follow-up. The study was conducted according to the principles of the Declaration of Helsinki (version: October 2008) and is registered with the Dutch Trial register (NTR3381).

      Results

      A total of 174 limbs were included between 2012 and 2019, 87 limbs in each group. Six patients crossed over from the bare-metal stent (BMS) group to the covered stent (CS) group, but were analyzed according to an intention-to-treat principle. Freedom from binary restenosis after 2 years of follow-up was 84.7% (95% CI 76.7%–92.7%) in the BMS group and 89.1% (95% CI 82.4%–95.8%) in the CS group (p = 0.40). Freedom from occlusion was 95.0% (95% CI 90.3%–95.7%) in the BMS group and 96.4% (95% CI 92.5%–100%) in the CS group (p = 0.66). Freedom from target lesion revascularization was 91.1% (95% CI 84.8%–97.3%) and 95.2% (95% CI 90.7%–99.7%), respectively (p = 0.31). Technical success, complications, hemodynamic success and clinical success were also comparable between both groups. Per-protocol analysis did not affect the outcomes of the study.

      Conclusion

      In this trial, no difference was found between covered and bare-metal balloon-expandable stents for treating advanced atherosclerotic lesions of the common iliac artery.
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