Author + information
- Received February 9, 2015
- Accepted March 13, 2015
- Published online July 1, 2015.
- Osamu Iida, MD∗∗ (, )
- Mitsuyoshi Takahara, MD, PhD†,‡,
- Yoshimitsu Soga, MD§,
- Masatsugu Nakano, MD, PhD‖,
- Yasutaka Yamauchi, MD, PhD¶,
- Kan Zen, MD, PhD#,
- Daizo Kawasaki, MD, PhD∗∗,
- Shinsuke Nanto, MD, PhD††,
- Hiroyoshi Yokoi, MD‡‡,
- Masaaki Uematsu, MD, PhD∗,
- on behalf of the ZEPHYR Investigators
- ∗Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Hyogo, Japan
- †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
- §Department of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan
- ‖Division of Cardiology, Saiseikai Yokohama-City Eastern Hospital, Kanagawa, Japan
- ¶Cardiovascular Center, Kikuna Memorial Hospital, Yokohama, Kikuna, Japan
- #Department of Cardiovascular Medicine, Omihachiman Community Medical Center, Tsuchidacho, Omihachiman, Japan
- ∗∗Cardiovascular Division, Department of Internal Medicine, Morinomiya Hospital, Osaka, Japan
- ††Department of Advanced Cardiovascular Therapeutics, Osaka University Graduate School of Medicine, Osaka, Japan
- ‡‡Cardiovascular Center, Fukuoka Sanno Hospital, Fukuoka City, Japan
- ↵∗Reprint requests and correspondence:
Dr. Osamu Iida, Kansai Rosai Hospital, Cardiovascular Center, 3-1-69 Inabaso, Amagasaki, Hyogo 660-8511, Japan.
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 mm2 and minimum stent area ≤12 mm2 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)
This study was supported by the General Incorporated Association Japan Endovascular Treatment Conference. Dr. Nanto has received grant support from Terumo, Japan. Dr. Yokoi has received honoraria for lectures. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 9, 2015.
- Accepted March 13, 2015.
- 2015 American College of Cardiology Foundation