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 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.

journal_name

J Atheroscler Thromb

authors

Tsujimura T,Takahara M,Iida O,Hiramori S,Hayakawa N,Karashima E,Miura T,Teramura M,Ichihashi K,Kojima T,Aihara H,Yamaoka T,Fujihara M,Tosaka A,Doijiri T,Mano T,Soga Y

doi

10.5551/jat.47399

subject

Has Abstract

pub_date

2019-10-01 00:00:00

pages

847-855

issue

10

eissn

1340-3478

issn

1880-3873

journal_volume

26

pub_type

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