1Universitätsklinikum Essen Klinik für Kardiologie und Angiologie Essen, Deutschland
Purpose
Endovascular treatment is the primary revascularization strategy for symptomatic peripheral artery disease (PAD), which affects lower limb endothelial function. Endothelial dysfunction is involved in the progression of atherosclerosis and is a relevant biomarker. The Biomimics stent, with its unique 3D geometry, promotes laminar swirling flow, providing superior hemodynamics. However, the impact on endothelial function is unknown. We now determined the effect of a helical vs. a conventional stenting on endothelial and vascular function in symptomatic PAD.
Methodology
The investigator-initiated, randomized-controlled MIMICS-FLOW trial randomized PAD patients, Rutherford 2, 3 and 4 to the BioMimics 3D stent (Veryan) or a conventional stent (Innova, Boston scientific). Vascular function was determined by flow-mediated dilation (FMD) in the non-stenotic proximal SFA before, one month and twelve months after lower limb intervention.
Results
70 Patients were 1:1 randomized. Rutherford and PACSS class as well as the location of the target lesions were balanced between the groups. One patient in the Biomimics and 2 patients in the Innova group required a reintervention. Within one month, a higher improvement in SFA FMD was observed in the Biomimics group (3.3%±1.3% to 4.3%±1.3%; p<0.05) as compared to conventional stenting group (3.1%±1.3% to 3.7%±1.2%; p<0.05; Improvement from baseline Biomimics 0.91 vs Innova 0.5%, p<0.05). Importantly, this effect was mirrored also by a greater increase in brachial FMD in the Biomimics (0.83%) vs. conventional group (0.4%, p<0.05). The 12-month data will be presented at the DGK-Congress.
Conclusion
Our RCT data provide evidence an improved vascular function through swirling flow with superior hemodynamics following Biomimics 3D stent implantation. These findings provide concepts for a mechanistic understanding in endovascular treatment strategies in PAD.