Takuya Tsujimura1, Mitsuyoshi Takahara2, Osamu Iida1, Seiichi Hiramori3, Naoki Hayakawa4, Eiji Karashima5, Takashi Miura6, Masanori Teramura7, Kei Ichihashi7, Tai Kojima8, Hideaki Aihara9, Terutoshi Yamaoka10, Masahiko Fujihara11, Atsushi Tosaka12, Tatsuki Doijiri13, Toshiaki Mano1, Yoshimitsu Soga3. 1. Cardiovascular Center, Kansai Rosai Hospital. 2. Department of Metabolic Medicine, Osaka University Graduate School of Medicine. 3. Department of Cardiology, Kokura Memorial Hospital. 4. Department of Cardiology, Asahi General Hospital. 5. Department of Cardiology, Shimonoseki Central Hospital. 6. Department of Cardiovascular Medicine, Shinshu University School of Medicine. 7. Department of Cardiovascular Medicine, Ichinomiya Nishi Hospital. 8. Department of Cardiology, Gifu Prefectural General Medical Center. 9. Department of Cardiology, Tsukuba Medical Center Hospital. 10. Department of Vascular Surgery, Matsuyama Red Cross Hospital. 11. Department of Cardiology, Kishiwada Tokushukai Hospital. 12. Department of Cardiology, Kawakita General Hospital. 13. Department of Cardiology, Yamato Seiwa Hospital.
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.
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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