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Dean Kereiakes M. Turco, B, McLaurin, R. Feldman, N. Farhat, J. Breall and M.Foster on behalf of the study investigato

The AMEthyst Trial A prospective randomized controlled study of the Medtronic Interceptor® PLUS Coronary Filter System for PCI of Degenerative SVG. Late Breaking Clinical Trial Presentation TCT 2007. Dean Kereiakes M. Turco, B, McLaurin, R. Feldman, N. Farhat, J. Breall and M.Foster

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Dean Kereiakes M. Turco, B, McLaurin, R. Feldman, N. Farhat, J. Breall and M.Foster on behalf of the study investigato

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  1. The AMEthyst TrialA prospective randomized controlled study of the Medtronic Interceptor® PLUS Coronary Filter System for PCI of Degenerative SVG Late Breaking Clinical Trial Presentation TCT 2007 Dean Kereiakes M. Turco, B, McLaurin, R. Feldman, N. Farhat, J. Breall and M.Foster on behalf of the study investigators

  2. Dean J. Kereiakes, M.D., FACC Disclosure: • SCIENTIFIC ADVISORY BOARD: • Cordis/Johnson & Johnson • Boston Scientific Corporation, Inc. • Abbott Vascular • Core Valve • RESEARCH GRANT SUPPORT: • Boston Scientific Corporation Inc. • Abbott Vascular • Medtronic • Daiichi Sankyo • CONSULTING: • Eli Lilly Co. • Daiichi Sankyo • Medtronic

  3. AMEthyst Study Device Medtronic Interceptor PLUS Filter Catheter 100 µ distal pores 1400-1800 µ proximal openings Nitinol Filter Basket 71% Open pore area Low profile 2.7 Fr 0.0014” wire Actuator handle

  4. AMEthyst Enrollment : 73 U.S. Centers - “Top 10” * Principal Investigator

  5. AMEthyst: Study Design Randomized, Open Label, Multicenter Trial De Novo or restenotic lesions of Saphenous Vein Grafts Vessel Diameter: 2.5-5.25mm Control DEP* n = 200 Interceptor® PLUS n= 600 2:1 randomization *GuardWire® or FilterWireTM EZ at physician’s discretion Clinical Procedure 30 days Primary Endpoint: MACE (death, MI, repeat revascularization) at 30 days Secondary Endpoints: Elevated CK, CK-MB during index hospitalization, in hospital MACE, device and clinical success

  6. AMEthyst Subject Selection Criteria Includes multivessel PCI with following restrictions: • Total of 2 lesions in up to 2 native vessels (non-target lesions [NTL]) • NTLs successfully treated before enrollment to study • Unlimited target lesions (TL) in up to 2 SVG’s Key Inclusion Criteria: • Subjective or Objectiveevidence of ischemia • TL in a SVG >50 and <100% stenosed • Target Vessel has TIMI 1 flow or greater Key Exclusion Criteria: • Recent Myocardial Infarction (MI) >24 hrs, with + CK-MB, or Acute MI • Surgery within 30 days • LVEF <25% • TL has been previously stented • TL within 5mm of graft ostium or <35mm from graft-native anastomosis

  7. AMEthyst Core Labs • QCA Core Lab • Brigham and Women’s Hospital, Boston, MA, USA • Jeffrey J. Popma, MD • Data Coordinating Center • Harvard Clinical Research Institute, Boston, MA, USA • Laura Mauri, MD • ECG Core Lab • Harvard Clinical Research Institute, Boston, MA, USA • Peter Zimetbaum, MD • Clinical Events Committee/DSMB • Harvard Clinical Research Institute, Boston, MA, USA • Donald Cutlip, MD

  8. AMEthyst Sample Size Calculation • INITIAL ASSUMPTIONS: • D30 MACE rate for Interceptor and Control group <10% • Power 80% • 1-sided alpha error 5% • Delta for equivalence 5.5% 600 Patients Control Device 200 Patients 2:1 Randomization Ratio Interceptor PLUS 400 patients SAFER Trial Borrow additional patients using Bayesian methods

  9. AMEthyst Revised Sample Size Calculations DSMB Safety Review 04/18/05 (first 300 patients) • No Safety Issues • However: • Observed control 30D MACE <<10% • ? Pooling with SAFER patients • ? Study Adequately Powered • Revised Assumptions • 30D MACE rate for control and Interceptor assumed < 6% • Power 80% • 1-sided alpha error 5% • Delta for equivalence 4.5% Continue Study Add 200 patients

  10. Clinical F/U30 days 522/533 97.9% Clinical F/U 30 days 258/265 97.4% FilterWire* n=73 GuardWire n= 194 AMEthyst Final Patient Distribution and Follow-up Patients Enrolled n=800 Randomized 2:1 Control DEP n = 267 Interceptor n = 533 *Additional optional control device added per Amendment Feb 2006

  11. AMEthyst Patient Demographics

  12. AMEthyst Procedural and Lesion Characteristics

  13. SVG Degenerative Score (% lumen irregularities ) Am J Cardiol 2005; 95(2) 173-7 0 (0-25%) 1 (26-50%) 2 (51-75%) 3 (76-100%)

  14. AMEthyst Extent of SVG Degeneration

  15. AMEthyst Procedural Characteristics

  16. AMEthyst Outcomes – in hospital

  17. AMEthyst Device Effectiveness (ITT population) Device successdefined as delivery, deployment and retrieval of the assigned device Clinical successdefined as delivery, deployment and retrieval of the assigned device with no in hospital MACE

  18. AMEthyst Outcomes to 30 days

  19. AMEthyst Primary Endpoint 30 day MACE P for Non-Inferiority 0.027 (for delta=4.5%) P for difference 0.77 7.2% 8.0% Control (n=18/250) Interceptor (n=40/501)

  20. Conclusions AMEthyst • The Interceptor® PLUS filter is not inferior in safety and efficacy to 30 days when compared with currently approved DEP device standards (GuardWire, FilterWire EZ). • A trend toward less frequent TVR (non-TL) to 30 days observed following Interceptor (vs. Control DEP) • Overall MACE to 30 days in DEP device-treated patients appears to be less frequent in contemporary PCI practice and deserves further study.

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