Ten-Year Clinical Follow-Up Following Bare-Nitinol Stent Implantation for Femoropopliteal Artery Disease.

Abstract

Aim: More than 5-year clinical outcomes after femoropopliteal (FP) stenting with bare-nitinol stent (BNS) have not yet been unclear. We investigate the long-term patency and mortality following FP stenting with BNS. Methods: This study was a multicenter retrospective study of a prospectively maintained database. From April 2004 to December 2011, 1824 consecutive patients (2211 limbs) who underwent FP stenting with BNS for de novo lesions were selected and analyzed. Primary endpoint was primary patency which was defined as treated vessel without restenosis and reintervention and its associated factors. Results: The prevalence of diabetes mellitus and dialysis was 60.5% and 23.8%, respectively. Chronic limb-threatening ischemia (CLTI) accounted for 30.8%. Chronic total occlusion (CTO) was found in 52.7%, and lesion length was more than 20 cm in 22.6%. During the median follow-up of 3.8 years (interquartile range, 1.4 to 7.4 years), 1049 cases lost patency, whereas 355 cases were dead without experiencing loss of patency. The primary patency (95% CI) was estimated to be 74.8%, 47.3% and 29.1% at 1-, 5- and 10-year. On multivariate analysis, female sex, age ≥ 80 years, diabetes, dialysis, CLTI, CTO, arterial calcification, long lesion (＞20 cm), and small vessel (≤ 4 mm) were the independent predictors of primary patency after FP stenting. In addition, the prognostic impact of age ≥ 80 years, CLTI, and arterial calcification was significantly attenuated afterwards (P＜0.05). Conclusions: Ten-year patency after BNS implantation for FP disease has been continuously reducing up to 10 years and the prognostic impact of risk factors was changed over time.