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1 o PTCA (n=516)

Randomize. CADILLAC. Study Design. Stone et al.Circulation 2000; 102: II-664. AMI <12 hours, any age, cardiogenic shock excluded n=2,665 at 76 centers in N.A., S.A. and Europe. Angiography. no. Met angiographic criteria n=2,082 (78%). Registry n=583 (22%). yes. MultiLink stent

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1 o PTCA (n=516)

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  1. Randomize CADILLAC Study Design Stone et al.Circulation 2000; 102: II-664 AMI <12 hours, any age, cardiogenic shock excluded n=2,665 at 76 centers in N.A., S.A. and Europe Angiography no Met angiographic criteria n=2,082 (78%) Registry n=583 (22%) yes MultiLink stent (n=512) 1o PTCA (n=516) 1o PTCA + Abciximab (n=529) MultiLink stent + Abciximab (n=525)

  2. CADILLAC Stone. Oral presentation. AHA 1999. • 1961 patients with acute MI • Target lesion 2.5-4 mm, < 70 mm length • Randomized: • Stent vs. PTCA • Abciximab vs. placebo • Shock excluded • Rx ASA, ticlopidine, heparin • ACT 200-300 w/abciximab • ACT >350 w/placebo • Primary endpoint • 6 month death/MI/urgent intervention

  3. CADILLAC [ Presentation of acute safety / outcome data ] • No difference between groups in mortality, stroke • Trend toward fewer reinfarctions in stent pts • Trend toward less ischemia-driven TVR in stent pts • No difference between groups in ICH Stent/A Stent/P PTCA/A PTCA/P TIMI 3 flow 96.7% 92.1% 95% 94.8% Rec isch 1.2% 3.9% 1.4% 4% Bleeding 4.5% 3.5% 5.1% 3.1% Stone. Oral presentation. AHA 1999.

  4. CADILLAC Stone, TCT 2000 • 2082 patients with acute MI (2.5-4.5 mm vessels) • Shock excluded • Randomized to : • PTCA • PTCA + abciximab • Stent (Multi-link) • Stent + abciximab • Crossover allowed • Primary endpoint : MACE at 6 mo (stent vs PTCA)

  5. CADILLAC Stone, TCT 2000 Outcomes at 6 Months

  6. p = 0.001 CADILLAC Primary Endpoint - MACE at 6 Months 20% 19.3% 15% 10.9% 10% Incidence 5% 0% 0 30 60 90 120 150 180 Days to event PTCA, no abciximab Stent, no abciximab Stone et al. Circ 2000; 102: II-664

  7. CADILLAC Primary Endpoint - MACE at 6 Months 20% 15.2% 15% 10.9% 10% 5% 0% 0 30 60 90 120 150 180 Days to event PTCA, abciximab Stent, no abciximab Incidence (%) Stone et al. Circ 2000; 102: II-664

  8. CADILLAC Secondary Endpoint MACE at 30 Days No Abciximab Abciximab 10 8 7.1 p = 0.04 % of Patients 6 5.0 4 2 0 Death, Disabling Stroke, Re-MI or Ischemic TVR Stone et al. Circ 2000; 102: II-664

  9. CADILLAC Seconday Endpoint - MACE at 6 Months 20% 19.3% 15.2% 15% 10.9% 10.8% 10% Incidence (%) 5% 0% 0 30 60 90 120 150 180 Days to event PTCA, no abx PTCA, abx Stent, no abx Stent, abx Stone et al. Circ 2000; 102: II-664

  10. CADILLAC Additional Benefits of Abciximab • Thrombotic bailout • Subacute Thrombosis • Ischemic TVR • Registry Patients

  11. CADILLAC Stone, TCT 2000 Treatment Received

  12. CADILLAC 30 Day Subacute Thrombosis 1.7% P=0.07 p=0.03 1% 0.6% 0% Stone et al. Circ 2000; 102: II-664

  13. CADILLAC Ischemic TVR p=NS p<0.001 p=0.12 p<0.02 p=NS p=0.04 Stone et al. Circ 2000; 102: II-664

  14. CADILLAC Angiographic Exclusion Registry: Hospital Mortality 47% received Abx; Mortality = 4.7% w/Abx vs. 8.3% w/o Abx, p = 0.22 Treatment received(n=583) Stone et al. Circ 2000; 102: II-664

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