12 MONTHS OUTCOMES OF POLYMER-FREE AMPHILIMUS ELUTING STENT NITIDES™ IN PATIENTS WITH COMPLEX FEMOROPOPLITEAL ARTERIAL DISEASE- A SINGLE CENTER EXPERIENCE.

Introduction: 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 stents 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 CT 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. 56 angioplasties were performed in the superficial femoral artery and in 5 patients in the p1 segment of the popliteal artery. Mean lesion length was 145.74mm. 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.