Background: The aim of this study was to evaluate the safety and effectiveness of carbon-coated self-expandable stents in the revascularization of atherosclerotic iliac artery lesions.
Methods: Between January 2012 and June 2016 54 carbon-coated self-expandable stents (Easy HiFlype and Easy Flype; manufactured by CID S.p.A., a member of Alvimedica Group, Istanbul, Turkey) in 40 patients were implanted in our Center. Early and 2-year outcomes have been evaluated in terms of major morbidity, mortality, primary patency, primary assisted patency, secondary patency, absence of target lesion restenosis (TLR), healing of the lesions/relief of symptoms, and limb salvage.
Results: The patients were predominantly males (32/40, 80%) with a mean age of 71 years (range 46-94). One patient (2.5%) had a documented nickel allergy. Mean duration of follow-up was 13.9 months (range 1-48). At 30 days no patient died and 1 patient underwent surgical revision of percutaneous femoral access. The estimated 2-year primary patency, primary assisted patency, secondary patency, absence of TLR, and limb salvage were 92.8%, 93.1%, 95.7%, 79.5%, and 100%, respectively. At univariate analysis none of the pre- or intra-operative factors significantly affected the primary and primary assisted patency rates. Secondary patency was significantly affected by absence of post-stent balloon dilatation (P=0.003). Absence of TLR was significantly affected by age more than 80 years (P=0.01) and common iliac artery lesions (P=0.02). These significances were confirmed at Cox regression analysis.
Conclusions: Use of carbon-coated self-expandable stents in atherosclerotic iliac lesions was safe and effective. At 2 years, the patency rates and the absence of TLR were encouraging. Post-stent balloon dilatation should be recommended in all cases. Older patients and common iliac artery lesions were risk factors for restenosis in the mid-term period.