A novel filter-based distal embolic protection device for percutaneous intervention of saphenous vein graft lesions: results of the AMEthyst randomized controlled trial.
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.
Kereiakes
Dean J
DJ
Christ Hospital Heart and Vascular Center, Cincinnati, Ohio, USA. lindner@fuse.net
Turco
Mark A
MA
Breall
Jeffrey
J
Farhat
Naim Z
NZ
Feldman
Robert L
RL
McLaurin
Brent
B
Popma
Jeffrey J
JJ
Mauri
Laura
L
Zimetbaum
Peter
P
Massaro
Joseph
J
Cutlip
Donald E
DE
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
D010975:Platelet Aggregation Inhibitors