title: Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies.
abstract: OBJECTIVE
  A prospective, multinational randomized controlled trial (RCT) and a complementary single-arm study evaluated the 2-year safety and effectiveness of a paclitaxel-coated drug-eluting stent (DES) in patients with superficial femoral artery lesions. The RCT compared the DES with percutaneous transluminal angioplasty (PTA) and provisional bare-metal stent (BMS) placement.
  
  
  BACKGROUND
  Local drug delivery for superficial femoral artery lesions has been investigated with the intent of limiting restenosis similarly to DES for the coronary arteries. One-year outcomes of DES in the superficial femoral artery are promising, but longer-term benefits have not been established.
  
  
  METHODS
  In the RCT, patients were randomly assigned to primary DES implantation (n = 236) or PTA (n = 238). Acute PTA failure occurred in 120 patients, who underwent secondary randomization to DES (n = 61) or BMS (n = 59) placement. The single-arm study enrolled 787 patients with DES treatment.
  
  
  RESULTS
  Compared with the control group, the primary DES group demonstrated significantly superior 2-year event-free survival (86.6% vs. 77.9%, p = 0.02) and primary patency (74.8% vs. 26.5%, p < 0.01). In addition, the provisional DES group exhibited superior 2-year primary patency compared with the provisional BMS group (83.4% vs. 64.1%, p < 0.01) and achieved higher sustained clinical benefit (83.9% vs. 68.4%, p = 0.05). Two-year freedom from target lesion revascularization with primary DES placement was 80.5% in the single-arm study and 86.6% in the RCT.
  
  
  CONCLUSIONS
  Two-year outcomes with the paclitaxel-eluting stent support its sustained safety and effectiveness in patients with femoropopliteal artery disease, including the long-term superiority of the DES to PTA and to provisional BMS placement. (Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery; NCT00120406; Zilver(®) PTX™ Global Registry; NCT01094678).
authors.affiliation: Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, California. Electronic address: mddake@stanford.edu.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Dake
authors.affiliation: Center for Critical Limb Care, Riverside Methodist Hospital, Columbus, Ohio.
authors.forename: Gary M
authors.initials: GM
authors.lastname: Ansel
authors.affiliation: The Vascular Center, Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
authors.affiliation: Department of Surgery, Jikei University Hospital, Tokyo, Japan.
authors.forename: Takao
authors.initials: T
authors.lastname: Ohki
authors.affiliation: Department of Diagnostic Imaging and Interventional Radiology, Tri-City Medical Center, Oceanside, California.
authors.forename: Richard R
authors.initials: RR
authors.lastname: Saxon
authors.affiliation: Department of Radiology, OSF St. Francis Medical Center, Peoria, Illinois.
authors.forename: H Bob
authors.initials: HB
authors.lastname: Smouse
authors.affiliation: MED Institute, Inc., West Lafayette, Indiana.
authors.forename: Scott A
authors.initials: SA
authors.lastname: Snyder
authors.affiliation: MED Institute, Inc., West Lafayette, Indiana.
authors.forename: Erin E
authors.initials: EE
authors.lastname: O'Leary
authors.affiliation: Department of Radiology, Klinikum Rosenheim, Rosenheim, Germany.
authors.forename: Gunnar
authors.initials: G
authors.lastname: Tepe
authors.affiliation: Department of Cardiology, Center for Vascular Medicine, Park Hospital, Leipzig, Germany.
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.affiliation: Department of Angiology, Herz Zentrum, Bad Krozingen, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
mesh_terms: D000368:Aged; D018572:Disease-Free Survival; D016503:Drug Delivery Systems; D054855:Drug-Eluting Stents; D005260:Female; D005263:Femoral Artery / Q000473:pathology*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000627:therapeutic use*; D061214:Patient Safety; D011150:Popliteal Artery / Q000473:pathology*; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel