Journal of Atherosclerosis and Thrombosis
Online ISSN : 1880-3873
Print ISSN : 1340-3478
ISSN-L : 1340-3478
Original Article
One-Year Clinical Outcomes following Implantation of InnovaTM Self-Expanding Nitinol Stents in Patients with Peripheral Artery Diseases Presenting Femoropopliteal Artery Lesions
Takuya TsujimuraMitsuyoshi TakaharaOsamu IidaSeiichi HiramoriNaoki HayakawaEiji KarashimaTakashi MiuraMasanori TeramuraKei IchihashiTai KojimaHideaki AiharaTerutoshi YamaokaMasahiko FujiharaAtsushi TosakaTatsuki DoijiriToshiaki ManoYoshimitsu Soga
ジャーナル フリー

2019 年 26 巻 10 号 p. 847-855


Aim: Although the InnovaTM 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 InnovaTM 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 InnovaTM 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 InnovaTM self-expanding nitinol stent placement for the treatment of FP lesions, including challenging cases in real-world settings.


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