title: A novel filter-based distal embolic protection device for percutaneous intervention of saphenous vein graft lesions: results of the AMEthyst randomized controlled trial.
abstract: OBJECTIVE
  We sought to evaluate the relative safety and efficacy of the novel Interceptor PLUS Coronary Filter System (Medtronic Vascular, Santa Rosa, California) compared with approved embolic-protection devices (e.g., GuardWire, Medtronic Vascular/FilterWire EZ, Boston Scientific, Natick, Massachusetts) during percutaneous coronary intervention (PCI) of degenerative saphenous vein grafts (SVG).
  
  
  BACKGROUND
  Percutaneous coronary intervention of degenerative SVG is associated with embolization of atherothrombotic debris and subsequent myocardial infarction in a significant portion of patients. The use of distal embolic-protection devices has previously been demonstrated to reduce major adverse cardiovascular events associated with PCI in these patients.
  
  
  METHODS
  In this multicenter, randomized noninferiority trial, 797 patients undergoing PCI with stenting of SVG stenoses (de novo or restenotic) with reference vessel diameter 2.5 mm to 5.25 mm were randomly assigned 2:1 to either the Interceptor PLUS (n = 533) or control distal-protection devices (GuardWire [n = 191], FilterWire EZ [n = 73]) at the physician's discretion.
  
  
  RESULTS
  The trial primary clinical end point (composite occurrence of death, myocardial infarction, or urgent repeat revascularization through 30 days) was observed in 8% and 7.3% of Interceptor and control-treated patients, respectively (p = 0.025 for noninferiority; p = 0.77 for difference). Key secondary end points for device and procedural success were similar between randomly assigned treatment strategies.
  
  
  CONCLUSIONS
  The Interceptor PLUS Coronary Filter System is noninferior in safety and efficacy to 30 days when compared with the GuardWire and FilterWire EZ distal embolic protection devices.
authors.affiliation: Christ Hospital Heart and Vascular Center, Cincinnati, Ohio, USA. lindner@fuse.net
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Kereiakes
authors.forename: Mark A
authors.initials: MA
authors.lastname: Turco
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Breall
authors.forename: Naim Z
authors.initials: NZ
authors.lastname: Farhat
authors.forename: Robert L
authors.initials: RL
authors.lastname: Feldman
authors.forename: Brent
authors.initials: B
authors.lastname: McLaurin
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
authors.forename: Peter
authors.initials: P
authors.lastname: Zimetbaum
authors.forename: Joseph
authors.initials: J
authors.lastname: Massaro
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000295:instrumentation / Q000401:mortality; D003251:Constriction, Pathologic; D001026:Coronary Artery Bypass / Q000009:adverse effects* / Q000401:mortality; D004617:Embolism / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005374:Filtration / Q000295:instrumentation*; D006083:Graft Occlusion, Vascular / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D012501:Saphenous Vein / Q000637:transplantation*; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D010975:Platelet Aggregation Inhibitors