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A Novel Filter-Based Distal Embolic Protection Device for Percutaneous Intervention of Saphenous Vein Graft Lesions

Results of the AMEthyst Randomized Controlled Trial

Dean J. Kereiakes, MD, FACC^_*,_*, Mark A. Turco, MD, FACC, Jeffrey Breall, MD, PhD, Naim Z. Farhat, MD, Robert L. Feldman, MD^¶, Brent McLaurin, MD^||, Jeffrey J. Popma, MD, FACC^_**, Laura Mauri, MD, MSc^_**,, Peter Zimetbaum, MD^,, Joseph Massaro, PhD, Donald E. Cutlip, MD^, on behalf of the AMEthyst Study Investigators

^_* The Christ Hospital Heart and Vascular Center and the Lindner Research Center, Cincinnati, Ohio
Center for Cardiac & Vascular Research, Washington Adventist Hospital, Takoma Park, Maryland
Krannert Institute of Cardiology, Indiana University of Medicine, Indianapolis, Indiana
North Ohio Heart Center, Elyria, Ohio
^¶ Munroe Regional Medical Center, Ocala, Florida
^|| Anderson Area Medical Center, Anderson, South Carolina
^_** Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts
Harvard Clinical Research Institute, Boston, Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts.

^_* Reprint requests and correspondence: Dr. Dean J. Kereiakes, The Lindner Center, 2123 Auburn Avenue, Suite 424, Cincinnati, Ohio 45219. (Email: lindner{at}fuse.net).

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.

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CABG = coronary bypass graft surgery   CK = creatine kinase   DES = drug-eluting stent(s)   FDA = Food and Drug Administration   GP = glycoprotein   ITT = intention to treat   MACE = major adverse cardiovascular events   MI = myocardial infarction   PCI = percutaneous coronary intervention   PP = per protocol   SVG = saphenous vein graft   TIMI = Thrombolysis In Myocardial Infarction   TVR = target vessel revascularization

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