title: 5-year follow-up of polytetrafluoroethylene-covered stents compared with bare-metal stents in aortocoronary saphenous vein grafts the randomized BARRICADE (barrier approach to restenosis: restrict intima to curtail adverse events) trial.
abstract: OBJECTIVE
  We sought to evaluate the utility of the JOSTENT polytetrafluoroethylene (PTFE) stent-graft (Jomed GmbH, Rangendingen, Germany) in patients with diseased saphenous vein grafts (SVGs) undergoing percutaneous coronary intervention (PCI).
  
  
  BACKGROUND
  Prior trials of the JOSTENT stent-graft did not mandate high-pressure implantation or prolonged dual antiplatelet therapy, and were limited by short-term follow-up.
  
  
  METHODS
  A total of 243 patients at 47 centers with 1 to 2 discrete lesions in SVGs were prospectively randomized to JOSTENT implantation (≥18 atm.) versus bare-metal stents (BMS). The JOSTENT patients were treated with aspirin indefinitely and clopidogrel for ≥8 months. Routine angiographic follow-up was performed at 8 months, and all patients were followed for 5 years.
  
  
  RESULTS
  The primary end point of in-lesion binary restenosis occurred in 31.8% of lesions treated with the JOSTENT versus 28.4% of lesions treated with BMS (relative risk: 1.12, 95% confidence interval [CI]: 0.72 to 1.75, p = 0.63). At 9 months, the major secondary end point of target vessel failure (death, myocardial infarction, or clinically driven target vessel revascularization) occurred in 32.2% of patients treated with the JOSTENT versus 22.1% of patients treated with BMS (hazard ratio: 1.54, 95% CI: 0.94 to 2.53, p = 0.08). During long-term follow-up, significantly more events accrued in the JOSTENT arm such that by 5 years target vessel failure had occurred in 68.3% of JOSTENT patients versus 51.8% of BMS patients (hazard ratio: 1.59, 95% CI: 1.13 to 2.23, p = 0.007).
  
  
  CONCLUSIONS
  The long-term prognosis for diseased SVGs requiring PCI is dismal. The JOSTENT PTFE stent-graft results in inferior outcomes compared with BMS, despite high-pressure implantation and prolonged dual antiplatelet therapy, a finding that becomes more evident with longer-term follow-up.
authors: Department of Medicine, Division of Cardiology, Columbia University, Medical Center/New York-Presbyterian Hospital, Cardiovascular Research Foundation, New York 10022, USA. gs2184@columbia.edu
authors: Gregg W
authors: GW
authors: Stone
authors: Sheldon
authors: S
authors: Goldberg
authors: Charles
authors: C
authors: O'Shaughnessy
authors: Mark
authors: M
authors: Midei
authors: Robert M
authors: RM
authors: Siegel
authors: Ecaterina
authors: E
authors: Cristea
authors: George
authors: G
authors: Dangas
authors: Alexandra J
authors: AJ
authors: Lansky
authors: Roxana
authors: R
authors: Mehran
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016009:Chi-Square Distribution; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D001026:Coronary Artery Bypass / Q000009:adverse effects* / Q000401:mortality; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D005260:Female; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011138:Polytetrafluoroethylene; D011446:Prospective Studies; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D012501:Saphenous Vein / Q000637:transplantation*; D015607:Stents; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D020099:Coated Materials, Biocompatible; D008670:Metals; D010975:Platelet Aggregation Inhibitors; D011138:Polytetrafluoroethylene