Osamu Iida1, Mitsuyoshi Takahara2, Yoshimitsu Soga3, Masatsugu Nakano4, Yasutaka Yamauchi5, Kan Zen6, Daizo Kawasaki7, Shinsuke Nanto8, Hiroyoshi Yokoi9, Masaaki Uematsu10. 1. Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Hyogo, Japan. Electronic address: iida.osa@gmail.com. 2. Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan; Department of Diabetes Care Medicine, Osaka University Graduate School of Medicine, Osaka, Japan. 3. Department of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan. 4. Division of Cardiology, Saiseikai Yokohama-City Eastern Hospital, Kanagawa, Japan. 5. Cardiovascular Center, Kikuna Memorial Hospital, Yokohama, Kikuna, Japan. 6. Department of Cardiovascular Medicine, Omihachiman Community Medical Center, Tsuchidacho, Omihachiman, Japan. 7. Cardiovascular Division, Department of Internal Medicine, Morinomiya Hospital, Osaka, Japan. 8. Department of Advanced Cardiovascular Therapeutics, Osaka University Graduate School of Medicine, Osaka, Japan. 9. Cardiovascular Center, Fukuoka Sanno Hospital, Fukuoka City, Japan. 10. Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Hyogo, Japan.
Abstract
OBJECTIVES: This study sought to assess the rate and predictors of 1-year restenosis after drug-eluting stent implantation for femoropopliteal (FP) lesions in patients with peripheral arterial disease. BACKGROUND: Zilver PTX, a paclitaxel-eluting stent for FP lesions, provides superior outcomes to angioplasty and bare-metal stents in clinical trials. However, its real-world outcomes and the associated features remain unclear. METHODS: This was a prospective multicenter study enrolling 831 FP lesions (797 limbs, 690 patients) treated by Zilver PTX implantation. The primary endpoint was 1-year restenosis. Secondary endpoints included major adverse limb event and stent thrombosis. RESULTS: Mean lesion length was 17 ± 10 cm. One-year restenosis, major adverse limb event, and stent thrombosis rates were 37%, 22%, and 2%, respectively. The generalized linear mixed model showed that lesion length ≥16 cm assessed by angiography and distal external elastic membrane area ≤27 mm(2) and minimum stent area ≤12 mm(2) assessed by intravascular ultrasound were independent risk factors for restenosis. One-year restenosis rates were 15% in cases with none of these risk factors and 50% in those with ≥2 risk factors. CONCLUSIONS: The current study demonstrated 1-year real-world outcomes after drug-eluting stent treatment for FP lesions, including challenging ones in clinical practice. Lesion length, external elastic membrane area, and minimum stent area were independent predictors for restenosis. (Zilver PTX for the Femoral Artery and Proximal Popliteal Artery-Prospective Multicenter Registry [ZEPHYR]; UMIN000008433).
OBJECTIVES: This study sought to assess the rate and predictors of 1-year restenosis after drug-eluting stent implantation for femoropopliteal (FP) lesions in patients with peripheral arterial disease. BACKGROUND: Zilver PTX, a paclitaxel-eluting stent for FP lesions, provides superior outcomes to angioplasty and bare-metal stents in clinical trials. However, its real-world outcomes and the associated features remain unclear. METHODS: This was a prospective multicenter study enrolling 831 FP lesions (797 limbs, 690 patients) treated by Zilver PTX implantation. The primary endpoint was 1-year restenosis. Secondary endpoints included major adverse limb event and stent thrombosis. RESULTS: Mean lesion length was 17 ± 10 cm. One-year restenosis, major adverse limb event, and stent thrombosis rates were 37%, 22%, and 2%, respectively. The generalized linear mixed model showed that lesion length ≥16 cm assessed by angiography and distal external elastic membrane area ≤27 mm(2) and minimum stent area ≤12 mm(2) assessed by intravascular ultrasound were independent risk factors for restenosis. One-year restenosis rates were 15% in cases with none of these risk factors and 50% in those with ≥2 risk factors. CONCLUSIONS: The current study demonstrated 1-year real-world outcomes after drug-eluting stent treatment for FP lesions, including challenging ones in clinical practice. Lesion length, external elastic membrane area, and minimum stent area were independent predictors for restenosis. (Zilver PTX for the Femoral Artery and Proximal Popliteal Artery-Prospective Multicenter Registry [ZEPHYR]; UMIN000008433).
Authors: Stefan Müller-Hülsbeck; Koen Keirse; Thomas Zeller; Herman Schroë; Juan Diaz-Cartelle Journal: J Endovasc Ther Date: 2016-05-18 Impact factor: 3.487