One-Year Clinical Outcomes following Implantation of InnovaTM Self-Expanding Nitinol Stents in Patients with Peripheral Artery Diseases Presenting Femoropopliteal Artery Lesions.

Abstract

Aim: Although the Innova™ self-expanding nitinol stent (Boston Scientific, Marlborough, MA) exhibits acceptable performance in long-term safety and efficacy when used for the treatment of femoropopliteal (FP) lesions, clinical outcomes following its implantation have not been systematically studied in real-world settings. We investigated the one-year clinical outcomes after implantation of Innova™ self-expanding nitinol stents for the treatment of FP lesions in real-world settings.Methods: In this multicenter study, 481 lesions in 453 consecutive patients with peripheral artery disease (PAD) (74 ± 9 years; male, 70%; diabetes mellitus, 61%; dialysis, 27%; critical limb ischemia, 37%) who underwent endovascular therapy with the implantation of Innova™ self-expanding nitinol stents for FP lesions were analyzed from February 2016 to April 2017. The primary endpoint was one-year restenosis, whereas the secondary endpoints included one-year major adverse limb events and predictors for one-year restenosis.Results: The mean lesion length was 18 ± 10 cm. One-year restenosis and major adverse limb event rates were 36% and 18%, respectively. Multivariate analysis revealed that the presence of diabetes mellitus (odds ratio [OR]: 1.83; 95% confidence interval [CI]: 1.07–3.13), distal reference vessel diameter (OR: 1.86; 95% CI: 1.09–3.16), spot stenting (OR: 2.27; 95% CI: 1.27–4.06), and lack of one-year cilostazol treatment (OR: 0.58; 95% CI: 0.33–1.00) were independent risk factors for one-year restenosis.Conclusion: The current study demonstrated one-year clinical outcomes after Innova™ self-expanding nitinol stent placement for the treatment of FP lesions, including challenging cases in real-world settings.