title: Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 12-Month Results.
abstract: OBJECTIVE
  This multicenter, prospective, post-market surveillance study in Japan evaluates the paclitaxel-coated Zilver PTX stent in real-world patients with complex lesions.
  
  
  BACKGROUND
  The Zilver PTX stent is the first drug-eluting stent (DES) approved for the superficial femoral artery. Previously, results from a large randomized study and a complementary, large single-arm study supported the safety and effectiveness of the DES.
  
  
  METHODS
  There were no exclusion criteria, and consecutive patients with symptomatic peripheral artery disease (PAD) treated with the DES were enrolled in the study. Clinically driven target lesion revascularization (TLR) was defined as reintervention performed for ≥50% diameter stenosis after recurrent clinical symptoms of PAD. Clinical benefit was defined as freedom from persistent or worsening symptoms of ischemia. Patency was evaluated by duplex ultrasound where physicians considered this standard of care.
  
  
  RESULTS
  In this study, 907 patients were enrolled at 95 institutions in Japan. There were numerous comorbidities including high incidences of diabetes (58.8%), chronic kidney disease (43.8%), and critical limb ischemia (21.5%). Lesions were also complex, with an average length of 14.7 cm, 41.6% total occlusions, and 18.6% in-stent restenosis. In total, 1,861 DES were placed in 1,075 lesions. Twelve-month follow-up was obtained for >95% of eligible patients. Freedom from TLR was 91.0%, and clinical benefit was 87.7% through 12 months. The 12-month primary patency rate was 86.4%.
  
  
  CONCLUSIONS
  Despite more challenging lesions, results from the current study are similar to outcomes from the previous Zilver PTX studies, confirming the benefit of the Zilver PTX DES in a real-world patient population. (Zilver PTX Post-Market Study in Japan; NCT02254837).
authors: Department of Cardiovascular Medicine, Fukuoka Sanno Hospital, Fukuoka, Japan. Electronic address: hiroyokoi@circus.ocn.ne.jp.
authors: Hiroyoshi
authors: H
authors: Yokoi
authors: Department of Surgery, Jikei University Hospital, Tokyo, Japan.
authors: Takao
authors: T
authors: Ohki
authors: Department of Radiology, Nara Medical University, Kashihara, Japan.
authors: Kimihiko
authors: K
authors: Kichikawa
authors: Division of Cardiovascular Medicine, Toho University, Ohashi Medical Center, Tokyo, Japan.
authors: Masato
authors: M
authors: Nakamura
authors: Division of Vascular Surgery, Division of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
authors: Kimihiro
authors: K
authors: Komori
authors: Nishinomiya Hospital Affairs, Nishinomiya Municipal Central Hospital, Nishinomiya, Japan.
authors: Shinsuke
authors: S
authors: Nanto
authors: Cook Research Incorporated, West Lafayette, Indiana.
authors: Erin E
authors: EE
authors: O'Leary
authors: Cook Research Incorporated, West Lafayette, Indiana.
authors: Aaron E
authors: AE
authors: Lottes
authors: Cook Research Incorporated, West Lafayette, Indiana.
authors: Scott A
authors: SA
authors: Snyder
authors: Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, California.
authors: Michael D
authors: MD
authors: Dake
mesh_terms: D000368:Aged; D054855:Drug-Eluting Stents; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan; D008297:Male; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000628:therapy*; D011150:Popliteal Artery; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D014654:Vascular Patency
chemical_list: D017239:Paclitaxel
keywords: drug-eluting stent(s); paclitaxel-eluting stent(s); peripheral artery disease; peripheral vascular disease; popliteal artery; superficial femoral artery