SPIDER S aphenous Vein Graft  P rotection  I n a  D istal  E mbolic Protection  R andomized Trial   Simon R. Dixon  MBChB,...
Objective <ul><li>To evaluate the  safety  and  efficacy  of the SPIDER ™ /SpideRX ™  Embolic Protection Device during PCI...
SPIDER Device <ul><li>5 sizes (3.0 – 7.0mm) </li></ul><ul><li>Heparin coated </li></ul><ul><li>6 or 7F guide catheter </li...
Study Design 732 pts with SVG lesions 80 clinical sites from Feb 2003-July 2005 GuardWire or FilterWire (EX/EZ*) N=357 SPI...
Major Inclusion Criteria Evidence of myocardial ischemia De novo lesion,   50% stenosis TIMI flow   1 Diameter   3.0mm ...
Major Exclusion Criteria <ul><li>Recent AMI with elevated baseline CK/CKMB </li></ul><ul><li>LVEF <25% </li></ul><ul><li>S...
Study Endpoints <ul><li>Primary Endpoint </li></ul><ul><ul><li>MACE at 30-days  = D eath, MI* (Q-wave and non-Q wave), TVR...
Study Design and Analysis <ul><li>Non-Inferiority Design </li></ul><ul><li>Sample Size : </li></ul><ul><ul><li>Expected ev...
Study Organization Bailer Research Group,  Lake Hopatcong, NJ Study Monitor HCRI, Boston, MA  Peter Zimetbaum MD ECG Core ...
Top Ten Enrollers <ul><li>Munroe Regional Medical Center, Robert Feldman MD </li></ul><ul><li>William Beaumont Hospital, W...
Clinical Characteristics 1.00 88.5% 88.2% Hypertension 0.12 45.1% 39.3% Diabetes 0.64 81.0% 82.5% Male 0.27 69.6    9.4 6...
Baseline Angiographic Data 0.77 14.4    9.6 14.6    10.1 Lesion length 0.96 40.6    20.7 40.5    21.6 Degeneration sco...
SVG Distribution SPIDER N=396 vessels Control N=379 vessels RCA RCA Circumflex Circumflex LAD LAD P=NS 92.4% lesions proxi...
Procedural Results 0.76 3.11    0.58 3.09    0.58 MLD In-stent (mm) 0.03 6.7    12.3 4.9    10.9 DS In-stent (%) 1.00 ...
Secondary Endpoints *Device success=Successful delivery, operation and retrieval device **Clinical success=Device success ...
Primary Endpoint: 30-Day MACE P=NS for all comparisons P = 0.79   for Superiority,  P = 0.012 for Non-Inferiority Intent-t...
30-Day MACE In Other Studies Superiority Non-Inferiority GuardWire GW & FW GW & FW GuardWire TriActiv SPIDER Emboshield Fi...
Conclusion <ul><li>SPIDER trial demonstrated that distal protection with the  SPIDER/SpideRX Embolic Protection Device  du...
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Non inferiority trial of SpiderRX to GuardWire or Filerwire ...

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Non inferiority trial of SpiderRX to GuardWire or Filerwire ...

  1. 1. 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 TCT 2005
  2. 2. Objective <ul><li>To evaluate the safety and efficacy of the SPIDER ™ /SpideRX ™ Embolic Protection Device during PCI of saphenous vein graft disease </li></ul>
  3. 3. SPIDER Device <ul><li>5 sizes (3.0 – 7.0mm) </li></ul><ul><li>Heparin coated </li></ul><ul><li>6 or 7F guide catheter </li></ul><ul><li>Delivery </li></ul><ul><ul><li>Guidewire of choice </li></ul></ul><ul><ul><li>3.2F Delivery catheter </li></ul></ul><ul><ul><li>Rapid exchange system (SpideRX) </li></ul></ul><ul><li>Retrieval </li></ul><ul><ul><li>4.2/4.9F catheter (SpideRX 4.2F) </li></ul></ul>Caution: Investigational device. Limited by US Federal Law to investigational use. Nitinol Mesh Filter Retrieval
  4. 4. Study Design 732 pts with SVG lesions 80 clinical sites from Feb 2003-July 2005 GuardWire or FilterWire (EX/EZ*) N=357 SPIDER/SpideRX* N=375 Randomization stratified by planned IIbIIIa use ASA & Plavix Non-Inferiority Analysis SpideRX & FilterWire EZ introduced Nov 2004 (76% FilterWire) (30% SpideRX)
  5. 5. Major Inclusion Criteria Evidence of myocardial ischemia De novo lesion,  50% stenosis TIMI flow  1 Diameter  3.0mm and  6.0mm  40mm proximal to distal anastomosis
  6. 6. Major Exclusion Criteria <ul><li>Recent AMI with elevated baseline CK/CKMB </li></ul><ul><li>LVEF <25% </li></ul><ul><li>SVG <6-months old </li></ul><ul><li>TIMI 0 Flow </li></ul><ul><li>Arterial conduit </li></ul><ul><li>Planned atherectomy </li></ul><ul><li>Creatinine >2.5mg/dL </li></ul><ul><li>TIA or stroke within 60-days </li></ul>
  7. 7. Study Endpoints <ul><li>Primary Endpoint </li></ul><ul><ul><li>MACE at 30-days = D eath, MI* (Q-wave and non-Q wave), TVR, urgent CABG </li></ul></ul><ul><li>Secondary Endpoints </li></ul><ul><ul><li>Safety (In-hospital MACE, CK/CKMB elevation, major bleeding & vascular complications or stroke in-hospital or 30-days, and Device success) </li></ul></ul><ul><ul><li>Efficacy (Clinical & Procedural success) </li></ul></ul>*Defined as CKMB >3x ULN
  8. 8. Study Design and Analysis <ul><li>Non-Inferiority Design </li></ul><ul><li>Sample Size : </li></ul><ul><ul><li>Expected event rate in each study arm 10.0% </li></ul></ul><ul><ul><li>Delta for equivalence = 5.5% </li></ul></ul><ul><ul><li>One sided  error = 0.05, Power 80% </li></ul></ul><ul><ul><li>732 evaluable patients to demonstrate non-inferiority </li></ul></ul><ul><li>Primary Endpoint Analysis: Intent-to-treat </li></ul>
  9. 9. Study Organization Bailer Research Group, Lake Hopatcong, NJ Study Monitor HCRI, Boston, MA Peter Zimetbaum MD ECG Core Lab Brigham & Women’s Hospital, Boston, MA (Jeffrey Popma, MD) Angiographic Core Lab Harvard Clinical Research Institute, Boston, MA. Data Management William W. O’Neill MD, William Beaumont Hospital Principal Investigator ev3, Plymouth, MN Sponsor
  10. 10. Top Ten Enrollers <ul><li>Munroe Regional Medical Center, Robert Feldman MD </li></ul><ul><li>William Beaumont Hospital, William O’Neill MD </li></ul><ul><li>Moses Cone Hospital, Thomas Stuckey MD </li></ul><ul><li>Peninsula Cardiology Associates, Frank Arena MD </li></ul><ul><li>St. Vincent Health Center, Jack Smith MD </li></ul><ul><li>Our Lady of Lourdes Medical Center, Randy Mintz MD </li></ul><ul><li>Wellmont Holston Valley Medical Center, Christopher Metzger MD </li></ul><ul><li>Washington Adventist Hospital, Mark Turco MD </li></ul><ul><li>Wake Heart Associates, J. Tift Mann, MD </li></ul><ul><li>Tallahassee Memorial Hospital, John Katopodis, MD </li></ul>
  11. 11. Clinical Characteristics 1.00 88.5% 88.2% Hypertension 0.12 45.1% 39.3% Diabetes 0.64 81.0% 82.5% Male 0.27 69.6  9.4 68.8  10.2 Age (yrs) 48.7  12.2 55.0% 59.4% 12.1% 91.4% SPIDER LVEF (%) CCS III/IV angina Previous MI Current smoker Dyslipidemia 0.09 53.0% 0.93 48.8  12.1 1.00 53.7% 0.73 11.2% 0.50 92.9% P-value Control
  12. 12. Baseline Angiographic Data 0.77 14.4  9.6 14.6  10.1 Lesion length 0.96 40.6  20.7 40.5  21.6 Degeneration score 0.29 11.7  5.8 11.2  5.7 SVG age (yrs) 379 396 No. vessels treated 15.5% 90.6% 70  12 0.99  0.50 3.26  0.67 SPIDER Thrombus grade  3 TIMI 3 flow Diameter stenosis (%) MLD (mm) RVD (mm) 0.26 69  12 0.76 14.4% 0.48 89.0% 0.12 1.04  0.48 0.08 3.34  0.63 P-value Control
  13. 13. SVG Distribution SPIDER N=396 vessels Control N=379 vessels RCA RCA Circumflex Circumflex LAD LAD P=NS 92.4% lesions proximal-mid 90.1% lesions proximal-mid Other
  14. 14. Procedural Results 0.76 3.11  0.58 3.09  0.58 MLD In-stent (mm) 0.03 6.7  12.3 4.9  10.9 DS In-stent (%) 1.00 98.1% 98.0% TIMI 3 flow 0.72 61.9% 63.5% Visible debris 0.12 3.8% 1.8% No-reflow 0.69 0.5% 1.0% Distal embolization 0.81 29.4% 30.3% IIbIIIa Inhibitor 0.08 26.9  14.5 25.1  13.4 Stent length per lesion 1.00 99.5% 99.2% Stent implantation 379 396 No. vessels treated SPIDER P-value Control
  15. 15. Secondary Endpoints *Device success=Successful delivery, operation and retrieval device **Clinical success=Device success with no in-hospital MACE 1.00 0.5% 0.5% Stroke Efficacy 0.37 89.0% 86.7% Clinical success** 0.49 93.1% 91.6% Procedural success 0.25 95.9% 94.0% Device success* Safety 0.79 1.6% 2.1% Transfusion 0.78 7.1% 7.9% In-hospital MACE SPIDER P-value Control
  16. 16. Primary Endpoint: 30-Day MACE P=NS for all comparisons P = 0.79 for Superiority, P = 0.012 for Non-Inferiority Intent-to-treat analysis
  17. 17. 30-Day MACE In Other Studies Superiority Non-Inferiority GuardWire GW & FW GW & FW GuardWire TriActiv SPIDER Emboshield FilterWire GuardWire TRAP
  18. 18. Conclusion <ul><li>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 </li></ul>

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