title: Long-term follow-up after percutaneous coronary intervention with polytetrafluoroethylene-covered Symbiot stents compared to bare metal stents, with and without FilterWire embolic protection, in diseased saphenous vein grafts.
abstract: OBJECTIVE
  The long-term clinical outcome of covered stents in the percutaneous treatment of diseased saphenous vein graft (SVG) has been disappointing. The single self-expanding polytetrafluoroethylene (PTFE)-covered Symbiot stent with a unique profile may present advantages that translate into superior long-term clinical outcomes. This study evaluated the safety, effectiveness and clinical outcome of the Symbiot covered stent system (Boston Scientific, Natick, Mass.) and FilterWire EX (Boston Scientific, Natick, Mass.) versus bare metal stents (BMS) in SVG intervention.
  
  
  RESULTS
  Between January 2003 and August 2005, 90 patients with degenerative SVG lesions were prospectively randomized at 6 study sites to Symbiot implantation (n = 30), BMS with FilterWire as embolic protection device (EPD, n = 30), or BMS without EPD (control group, n = 30). The primary end point was reduction in peri-procedural cardiac enzyme rise. The major secondary end points were in-hospital, 6-month and long-term target vessel failure rates, defined as the cumulative of death, myocardial infarction and clinically driven target lesion revascularization. There was no significant reduction in median [IQR] post-procedural troponin-I rise in the Symbiot group compared to the FilterWire or the control group (0.08 [0-1.40] microg/l; 0.06 [0-0.28] microg/l; and 0.04 [0-0.31] microg/l, P = 0.58). At 7.4 +/- 1.3 (mean +/- SD) years, there were numerically less deaths in the Symbiot group, although this did not reach statistical significance (P = 0.20). There was no significant difference in TVF-free survival between the treatment groups (P = 0.98).
  
  
  CONCLUSIONS
  This study failed to show a procedural or long-term clinical advantage for the Symbiot PTFE-covered stent in the treatment of degenerated SVG.
authors: Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium. johan.bennett@uzleuven.be
authors: Johan
authors: J
authors: Bennett
authors: Jo
authors: J
authors: Dens
authors: Francis
authors: F
authors: Stammen
authors: Patrick
authors: P
authors: Coussement
authors: Luc
authors: L
authors: Janssens
authors: Marc
authors: M
authors: Claeys
authors: Mathias
authors: M
authors: Vrolix
authors: Peter
authors: P
authors: Sinnaeve
authors: Christophe
authors: C
authors: Dubois
authors: Walter
authors: W
authors: Desmet
mesh_terms: D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation* / Q000379:methods*; D011138:Polytetrafluoroethylene; D011446:Prospective Studies; D011474:Prosthesis Design; D012501:Saphenous Vein / Q000637:transplantation*; D015607:Stents; D013997:Time Factors
chemical_list: D011138:Polytetrafluoroethylene