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Greater Improvement in Endothelial Function and Reduced Inflammation with SELUTION SLR Sirolimus-Eluting Balloon Compared to IN.PACT Paclitaxel-Coated Balloon

https://doi.org/10.1007/s00392-025-02625-4

Olga Petrikhovich (Essen)1, J. Lortz (Essen)1, D. Messiha (Essen)1, S. Fakea (Essen)1, M. Sacirovic (Essen)1, B. Akan (Essen)1, T. Rassaf (Essen)1, C. Rammos (Essen)1

1Universitätsklinikum Essen Klinik für Kardiologie und Angiologie Essen, Deutschland

 

Aim:

Percutaneous angioplasty and drug coated balloon (DCB) treatment alter the endothelial homeostasis, but the impact and detailed mechanisms are incompletely understood. We aim to determine the impact and mechanisms of action of sirolimus and paclitaxel, known cytostatic and cytotoxic drugs, on endothelial function in symptomatic peripheral artery disease (PAD). This is the first and only randomized study investigating the effects of the novel SELUTION SLR sirolimus-coated balloon (SCB) vs. paclitaxel coated balloons (PCB) in terms of endothelial function. 

Methods

Limus FLOW is an investigator-initiated randomized controlled trial in which 70 PAD patients were planned to be randomized to SELUTION SLR SCB or IN.PACT PCB. The primary objective is to compare the local endothelial function through flow-mediated dilation (FMD) of the SFA, before intervention, at 1 and 12 month follow-up in the proximal SFA (target vessel). Furthermore, blood samples are analyzed for the presence of inflammatory markers. 

Results

70 patients were enrolled, 36 were treated with SELUTION SLR SCB and 34 were treated with IN.PACT PCB. All patients have completed the 1 month follow up. At 1 month, there was a significant improvement in endothelial function after revascularization in both group, however, sirolimus lead to a  significantly greater improvement  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. By the time of the presentation, the 12-month outcomes for the entire cohort will be reported.

Conclusions

Limus FLOW is the first ever head to head comparison of the novel SELUTION SLR SCB vs IN.PACT PCB. The study explores a novel concept to achieve a more profound mechanistic comprehension of endothelial function after the application of drug eluting balloons. One month data shows better outcomes in terms of endothelial function after interventional treatment of PAD following SELUTION SLR SCB along with a reduction of inflammatory markers compared to IN.PACT PCB. 

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