title: 1-Year Results of the ZEPHYR Registry (Zilver PTX for the Femoral Artery and Proximal Popliteal Artery): Predictors of Restenosis.
abstract: OBJECTIVE
  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.affiliation: Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Hyogo, Japan. Electronic address: iida.osa@gmail.com.
authors.forename: Osamu
authors.initials: O
authors.lastname: Iida
authors.affiliation: 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.
authors.forename: Mitsuyoshi
authors.initials: M
authors.lastname: Takahara
authors.affiliation: Department of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan.
authors.forename: Yoshimitsu
authors.initials: Y
authors.lastname: Soga
authors.affiliation: Division of Cardiology, Saiseikai Yokohama-City Eastern Hospital, Kanagawa, Japan.
authors.forename: Masatsugu
authors.initials: M
authors.lastname: Nakano
authors.affiliation: Cardiovascular Center, Kikuna Memorial Hospital, Yokohama, Kikuna, Japan.
authors.forename: Yasutaka
authors.initials: Y
authors.lastname: Yamauchi
authors.affiliation: Department of Cardiovascular Medicine, Omihachiman Community Medical Center, Tsuchidacho, Omihachiman, Japan.
authors.forename: Kan
authors.initials: K
authors.lastname: Zen
authors.affiliation: Cardiovascular Division, Department of Internal Medicine, Morinomiya Hospital, Osaka, Japan.
authors.forename: Daizo
authors.initials: D
authors.lastname: Kawasaki
authors.affiliation: Department of Advanced Cardiovascular Therapeutics, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Nanto
authors.affiliation: Cardiovascular Center, Fukuoka Sanno Hospital, Fukuoka City, Japan.
authors.forename: Hiroyoshi
authors.initials: H
authors.lastname: Yokoi
authors.affiliation: Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Hyogo, Japan.
authors.forename: Masaaki
authors.initials: M
authors.lastname: Uematsu
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002317:Cardiovascular Agents / Q000008:administration & dosage; D054855:Drug-Eluting Stents; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D016014:Linear Models; D008297:Male; D015999:Multivariate Analysis; D016017:Odds Ratio; D017239:Paclitaxel / Q000008:administration & dosage; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D011859:Radiography; D012008:Recurrence; D012307:Risk Factors; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D017239:Paclitaxel
keywords: drug-eluting stent; endovascular therapy; femoropopliteal lesion; intravascular ultrasound; restenosis