12 Months Outcomes of Polymer-Free Amphilimus Eluting Stent Nitides in Patients With Complex Femoropopliteal Arterial Disease - A Single Center Experience

Abstract

Background

Nitides (Alvimedica, Istanbul, Turkey) is a novel polymer-free stent, which elutes Amphilimus; a combination of sirolimus and long chain fatty acids. Aim of this prospective single-center study is to assess the efficacy and 12-months outcomes of patients with femoropopliteal arterial disease, who underwent successful angioplasty with implantation of Amphilimus-eluting stent Nitides.

Methods

Patients with peripheral arterial disease who underwent angioplasty of the femoropopliteal segment with DES Nitides from August 2021 to February 2024 were included in the study. Primary endpoints included in-stent restenosis verified by Duplex ultrasound or computed tomography angiography of the lower limbs at 12 months. Secondary endpoints included major amputation, clinically driven target lesion revascularization (CD-TLR) and cardiovascular mortality during follow-up.

Results

A total of 61 angioplasties in 58 consecutive patients were performed. 82.7% were male patients with a mean age of 64.26 years. Fifty-six angioplasties were performed in the superficial femoral artery and in 5 patients in the p1 segment of the popliteal artery. Mean lesion length was 145.74 mm. A total of 72.1% of the lesions were chronic total occlusions, Tasc C and Tasc D lesions were 36.1% and 34.4%, respectively. Technical success was 100%. Primary patency was 91.2% (n = 52) and freedom from CD-TLR rate was 96.5% (n = 55) at 12 months. One patient underwent major amputation at 11 months (1.75%) and cardiovascular related mortality was 6.89% (n = 4).

Conclusion

This monocentric prospective study demonstrated that Amphilimus-eluting stent Nitides is safe, with good patency outcomes in complex femoropopliteal lesions and high rates of freedom from CD-TLR.