Sirolimus vs paclitaxel for femoropopliteal peripheral artery disease - The limus flow randomized trial

Aim Drug coated balloon (DCB) treatment is recommended for peripheral endovascular revascularization. Sirolimus and Paclitaxel are both antirestenotic agents, yet both exert different pharmacomechanic properties. Until now, no direct comparison of sirolimus-coated balloons (SCB) with paclitaxel coated balloons (PCB) has been conducted. In a randomized controlled study we now aimed to investigate the effects of SCB vs. PCB on vasomotion and clinical outcomes. Methods Limus FLOW was an investigator-initiated randomized controlled trial in which 70 PAD patients were randomized to SCB or PCB. The primary objective was to compare the local endothelial function through flow-mediated dilation (FMD) of the SFA, before intervention, at 1, 6 and 12 month follow-up in the proximal SFA (target vessel). Futhermore primary patency and target lesion revascularization and inflammatory markers were evaluated. Results At 1,6 and 12 months, there was a significant improvement in endothelial function after revascularization in both group, however, sirolimus lead to a significantly greater improvement as compared to paclitaxel. The improvement in endothelial function was corroborated by reduced inflammatory markers such as interleukin, leukocytes, HS-CRP and homocysteine in the sirolimus group after 1 month. No differences were observed for primary patency or target lesion revascularization. Conclusions Limus FLOW is the first head-to-head comparison of SCB vs PCB. The study explores a novel concept to achieve a more profound mechanistic understanding of endothelial function after the application of DCBs. Improved outcomes in terms of endothelial function after interventional treatment of PAD following CB along with a reduction of inflammatory markers as compared to PCB did not translate into clinical endpoints.