OBJECTIVES: 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.
RCT Entities:
OBJECTIVES: 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.