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SPIDER S aphenous Vein Graft P rotection I n a D istal E mbolic Protection R andomized Trial

TCT 2005. SPIDER S aphenous Vein Graft P rotection I n a D istal E mbolic Protection R andomized Trial. Simon R. Dixon MBChB, William W. O’Neill MD William Beaumont Hospital, on behalf on the SPIDER Investigators. 18 October 2005. Objective.

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SPIDER S aphenous Vein Graft P rotection I n a D istal E mbolic Protection R andomized Trial

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  1. TCT 2005 SPIDERSaphenous Vein Graft Protection In a Distal Embolic Protection Randomized Trial Simon R. Dixon MBChB, William W. O’Neill MD William Beaumont Hospital, on behalf on the SPIDER Investigators 18 October 2005

  2. Objective • To evaluate the safety and efficacy of the SPIDER™/SpideRX™ Embolic Protection Device during PCI of saphenous vein graft disease

  3. 5 sizes (3.0 – 7.0mm) Heparin coated 6 or 7F guide catheter Delivery Guidewire of choice 3.2F Delivery catheter Rapid exchange system (SpideRX) Retrieval 4.2/4.9F catheter (SpideRX 4.2F) SPIDER Device Nitinol Mesh Filter Retrieval Caution: Investigational device. Limited by US Federal Law to investigational use.

  4. Study Design 732 pts with SVG lesions 80 clinical sites from Feb 2003-July 2005 ASA & Plavix Randomization stratified by planned IIbIIIa use SPIDER/SpideRX* N=375 GuardWire or FilterWire (EX/EZ*) N=357 (30% SpideRX) (76% FilterWire) Non-Inferiority Analysis SpideRX & FilterWire EZ introduced Nov 2004

  5. Evidence of myocardial ischemia Diameter 3.0mm and 6.0mm De novo lesion, 50% stenosis TIMI flow 1 40mm proximal to distal anastomosis Major Inclusion Criteria

  6. Major Exclusion Criteria • Recent AMI with elevated baseline CK/CKMB • LVEF <25% • SVG <6-months old • TIMI 0 Flow • Arterial conduit • Planned atherectomy • Creatinine >2.5mg/dL • TIA or stroke within 60-days

  7. Study Endpoints • Primary Endpoint • MACE at 30-days = Death, MI* (Q-wave and non-Q wave), TVR, urgent CABG • Secondary Endpoints • Safety (In-hospital MACE, CK/CKMB elevation, major bleeding & vascular complications or stroke in-hospital or 30-days, and Device success) • Efficacy (Clinical & Procedural success) *Defined as CKMB >3x ULN

  8. Study Design and Analysis • Non-Inferiority Design • Sample Size: • Expected event rate in each study arm 10.0% • Delta for equivalence = 5.5% • One sided  error = 0.05, Power 80% • 732 evaluable patients to demonstrate non-inferiority • Primary Endpoint Analysis: Intent-to-treat

  9. Study Organization

  10. Top Ten Enrollers • Munroe Regional Medical Center, Robert Feldman MD • William Beaumont Hospital, William O’Neill MD • Moses Cone Hospital, Thomas Stuckey MD • Peninsula Cardiology Associates, Frank Arena MD • St. Vincent Health Center, Jack Smith MD • Our Lady of Lourdes Medical Center, Randy Mintz MD • Wellmont Holston Valley Medical Center, Christopher Metzger MD • Washington Adventist Hospital, Mark Turco MD • Wake Heart Associates, J. Tift Mann, MD • Tallahassee Memorial Hospital, John Katopodis, MD

  11. Clinical Characteristics

  12. Baseline Angiographic Data

  13. Control N=379 vessels SPIDER N=396 vessels RCA RCA Circumflex Circumflex LAD LAD Other P=NS 92.4% lesions proximal-mid 90.1% lesions proximal-mid SVG Distribution

  14. Procedural Results

  15. Secondary Endpoints *Device success=Successful delivery, operation and retrieval device **Clinical success=Device success with no in-hospital MACE

  16. Primary Endpoint: 30-Day MACE P = 0.79for Superiority,P = 0.012 for Non-Inferiority P=NS for all comparisons Intent-to-treat analysis

  17. GW & FW GuardWire Emboshield GuardWire FilterWire GuardWire GW & FW SPIDER TriActiv TRAP Superiority Non-Inferiority 30-Day MACE In Other Studies

  18. Conclusion • SPIDER trial demonstrated that distal protection with the SPIDER/SpideRX Embolic Protection Device during SVG intervention results in a similar rate of MACE at 30-days and secondary safety endpoints, compared to distal protection with the GuardWire and FilterWire devices

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