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, Mark A. Turco, Jeffrey Breall, Naim Z. Farhat, Robert L. Feldman, Brent McLaurin, Jeffrey J. Popma, Laura Mauri, Peter Zimetbaum, Joseph Massaro, Donald E. Cutlip

Research output: Contribution to journalArticle

31 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)248-257
Number of pages10
JournalJACC: Cardiovascular Interventions
Volume1
Issue number3
DOIs
StatePublished - Jun 2008

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Embolic Protection Devices
Saphenous Vein
Percutaneous Coronary Intervention
Randomized Controlled Trials
Transplants
Blood Vessels
Myocardial Infarction
Safety
Equipment and Supplies
Pathologic Constriction
Clinical Trials
Physicians
milbemycin oxime

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

A Novel Filter-Based Distal Embolic Protection Device for Percutaneous Intervention of Saphenous Vein Graft Lesions. Results of the AMEthyst Randomized Controlled Trial. / Kereiakes, Dean J.; Turco, Mark A.; Breall, Jeffrey; Farhat, Naim Z.; Feldman, Robert L.; McLaurin, Brent; Popma, Jeffrey J.; Mauri, Laura; Zimetbaum, Peter; Massaro, Joseph; Cutlip, Donald E.

In: JACC: Cardiovascular Interventions, Vol. 1, No. 3, 06.2008, p. 248-257.

Research output: Contribution to journalArticle

Kereiakes, Dean J. ; Turco, Mark A. ; Breall, Jeffrey ; Farhat, Naim Z. ; Feldman, Robert L. ; McLaurin, Brent ; Popma, Jeffrey J. ; Mauri, Laura ; Zimetbaum, Peter ; Massaro, Joseph ; Cutlip, Donald E. / A Novel Filter-Based Distal Embolic Protection Device for Percutaneous Intervention of Saphenous Vein Graft Lesions. Results of the AMEthyst Randomized Controlled Trial. In: JACC: Cardiovascular Interventions. 2008 ; Vol. 1, No. 3. pp. 248-257.
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abstract = "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.",
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T1 - A Novel Filter-Based Distal Embolic Protection Device for Percutaneous Intervention of Saphenous Vein Graft Lesions. Results of the AMEthyst Randomized Controlled Trial

AU - Kereiakes, Dean J.

AU - Turco, Mark A.

AU - Breall, Jeffrey

AU - Farhat, Naim Z.

AU - Feldman, Robert L.

AU - McLaurin, Brent

AU - Popma, Jeffrey J.

AU - Mauri, Laura

AU - Zimetbaum, Peter

AU - Massaro, Joseph

AU - Cutlip, Donald E.

PY - 2008/6

Y1 - 2008/6

N2 - 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.

AB - 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.

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