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Baseline Characteristics

Baseline Characteristics. Baseline High Risk Features. Invasive Management. *In patients receiving study antithrombin pre angiography. †median (IQR). Primary Endpoint Measures (ITT). UFH/Enoxaparin + GPI vs. Bivalirudin + GPI. P NI <0.0001 P Sup = 0.93. P NI = 0.007 P Sup = 0.39.

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Baseline Characteristics

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  1. Baseline Characteristics

  2. Baseline High Risk Features

  3. Invasive Management *In patients receiving study antithrombin pre angiography †median (IQR)

  4. Primary Endpoint Measures (ITT) UFH/Enoxaparin + GPI vs. Bivalirudin + GPI PNI <0.0001 PSup = 0.93 PNI = 0.007 PSup = 0.39 PNI =0.0001 PSup = 0.38

  5. Primary Endpoint Measures (ITT) UFH/Enoxaparin + GPI vs. Bivalirudin + GPI p value(non inferior)(superior) UFH/Enox + IIb/IIIa Primary endpoint Risk ratio ±95% CI Bival + IIb/IIIa RR (95% CI) <0.001 0.93 Net clinical outcome 11.8% 11.7% 1.01 (0.90-1.12) 0.015 0.39 Ischemic composite Upper boundary non-inferiority 7.7% 7.3% 1.07 (0.92-1.23) <0.001 0.38 Major bleeding 5.3% 5.7% 0.93 (0.78-1.10) Bivalirudin + IIb/IIIa better UFH/Enox + IIb/IIIa better

  6. Primary Endpoint Measures (ITT) UFH/Enoxaparin + GPI vs. Bivalirudin Alone PNI <0.0001 PSup = 0.015 PNI = 0.011 PSup = 0.32 PNI <0.0001 PSup <0.0001

  7. Primary Endpoint Measures (ITT) UFH/Enoxaparin + GPI vs. Bivalirudin Alone p value(non inferior)(superior) UFH/Enox + IIb/IIIa Primary endpoint Risk ratio ±95% CI Bival alone RR (95% CI) <0.001 0.015 Net clinical outcome 10.1% 11.7% 0.86 (0.77-0.97) 0.02 0.32 Ischemic composite 7.8% 7.3% 1.08 (0.93-1.24) Upper boundary non-inferiority <0.001 <0.001 Major bleeding 3.0% 5.7% 0.53 (0.43-0.65) Bivalirudin alone better UFH/Enox + IIb/IIIa better

  8. PSup = 0.32 PSup = 0.34 PSup = 0.35 PSup = 0.78 Components of the Ischemic Composite UFH/Enoxaparin + GPI vs. Bivalirudin + GPI vs. Bivalirudin Alone

  9. Major Bleeding Endpoints UFH/Enoxaparin + GPI vs. Bivalirudin + GPI vs. Bivalirudin Alone PSup=0.31 PSup<.001 PSup=0.38 PSup<0.0001

  10. Major Bleeding (Primary Endpoint) Values in yellow = P<0.05

  11. Minor Bleeding (Non CABG) Values in yellow = P<0.05

  12. Bleeding Endpoints (Non-CABG) P1 = Bivalirudin+GPI vs. UFH/Enox+GPI; P2 = Bivalirudin alone vs. UFH/Enox+GPI

  13. 10.6% 0.86 (0.71-1.03) 0.05 0.86 (0.74-0.99) 0.02 0.03 0.16 7.8% 13.7% 10.4% 0.90 (0.77-1.05) 8.9% 10.8% 0.09 9.5% 0.79 (0.64-0.97) 9.2% 10.9% 11.8% 0.87 (0.75-1.00) 0.09 12.9% 0.03 0.71 0.90 (0.78-1.04) 0.12 16.8% 9.5% 0.16 16.1% 9.8% 14.7% 11.5% 11.6% 13.5% 10.9% 0.96 (0.77-1.19) 0.82 (0.68-0.98) 0.86 (0.70-1.04) 0.88 (0.75-1.02) Net Clinical Outcome Composite UFH/Enoxaparin + IIb/IIIa vs. Bivalirudin Alone UFH/Enox + IIb/IIIa Risk ratio ±95% CI Bival Alone RR (95% CI) P Pint Age <65 (n=5051) Age ≥65 (n=4164) 0.89 Men (n=6444) Women (n=2771) 0.91 Diabetes (n=2585) No diabetes (n=6630) 0.28 CrCl ≥60 (n=6993)CrCl <60 (n=1644) 0.43 US (n=5224)OUS (n=3991) 0.47 Bivalirudin alone better UFH/Enox + IIb/IIIa better

  14. 12.2% 13.7% <0.001 13.0% 0.61 9.2% 0.96 (0.80-1.14) 0.23 12.2% 0.92 (0.80-1.06) 0.76 (0.65-0.89) 13.3% 0.01 10.6% 7.1% 11.3% 11.1% 1.02 (0.86-1.21) 0.81 (0.69-0.95) 8.6% 9.4% 0.75 (0.61-0.93) 0.01 0.83 6.4% 10.2% 0.63 (0.43-0.91) 0.01 0.34 9.4% 10.2% 0.92 (0.77-1.10) 13.9% 15.2% 0.92 (0.76-1.11) 0.36 Net Clinical Outcome Composite UFH/Enoxaparin + IIb/IIIa vs. Bivalirudin Alone UFH/Enox + IIb/IIIa Risk ratio ±95% CI Bival Alone RR (95% CI) P Pint Biomarkers (CK/Trop) Elevated (n=5368) Normal (n=3841) 0.35 ST Deviation Yes (n=3197) No (n=6008) 0.42 TIMI Risk Score Low (0-2) (n=1291) Intermed (3-4) (n=4407) High (5-7) (n=2449) 0.18 Pre Thienopyridine Yes (n=5192) No (n=4023) 0.02 Bivalirudin alone better UFH/Enox + IIb/IIIa better

  15. 8.3% 11.6% 9.8% 13.3% 0.85 (0.67-1.06) 0.87 (0.75-1.00) 0.15 0.09 0.84 0.86 9.2% 10.6% 9.4% 18.2% 0.97 (0.75-1.26) 0.98 (0.78-1.23) 12.5% 5.1% 14.4% 6.5% 0.78 (0.58-1.04) 0.87 (0.73-1.05) 0.09 0.14 Net Clinical Outcome Composite UFH/Enoxaparin + IIb/IIIa vs. Bivalirudin Alone UFH/Enox + IIb/IIIa Risk ratio ±95% CI Bival Alone RR (95% CI) P Pint Actual treatment PCI (n=5170) CABG (n=1048) Medical (n=2989) 0.59 Rand. to angio/interv. Early (<3.0 h) Intermediate (3.0-19.7 h) Late (≥19.7 h) tertiles 0.62 A-thrombin crossover No prior AT (n=3290) Consistent Rx (n=5519) Crossover (n=3211) 9.1% 10.0% 0.91 (0.73-1.12) 0.36 0.46 0.56 6.7% 7.1% 0.94 (0.80-1.10) 10.6% 12.6% 0.84 (0.65-1.10) 0.21 Bivalirudin alone better UFH/Enox + IIb/IIIa better

  16. P (log rank) Estimate UFH/Enoxaparin + IIb/IIIa (N=4603) 11.7% 0.89 Bivalirudin + IIb/IIIa (N=4604) 11.8% 0.014 Bivalirudin alone (N=4612) 10.1% Net Clinical Outcome Composite Endpoint UFH/Enoxaparin + GPI vs. Bivalirudin + GPI vs. Bivalirudin Alone 15 10 Cumulative Events (%) 5 0 0 5 10 15 20 25 30 35 Days from Randomization

  17. Ischemic Composite Endpoint UFH/Enoxaparin + GPI vs. Bivalirudin + GPI vs. Bivalirudin Alone 15 P (log rank) Estimate UFH/Enoxaparin + IIb/IIIa (N=4603) 7.3% 0.37 Bivalirudin + IIb/IIIa (N=4604) 7.7% 10 0.30 Bivalirudin alone (N=4612) 7.8% Cumulative Events (%) 5 0 0 5 10 15 20 25 30 35 Days from Randomization

  18. 15 UFH/Enoxaparin + IIb/IIIa (N=4603) 5.7% 10 5 0 0 5 10 15 20 25 30 35 Major Bleeding Endpoint UFH/Enoxaparin + GPI vs. Bivalirudin + GPI vs. Bivalirudin Alone P (log rank) Estimate 0.41 Bivalirudin + IIb/IIIa (N=4604) 5.3% <0.0001 Bivalirudin alone (N=4612) 3.0% Cumulative Events (%) Days from Randomization

  19. Event Rates and Power Calculations NI = non-inferiority; Sup = superiority

  20. Summary Conclusions: Primary Results NI = non-inferiority; Sup = superiority

  21. Summary Conclusions: Primary Results NI = non-inferiority; Sup = superiority

  22. Summary Conclusions: Primary Results NI = non-inferiority; Sup = superiority

  23. Conclusions: Primary Results NI = non-inferiority; Sup = superiority

  24. Clinical Implications • In patients with moderate-high risk ACS undergoing an early invasive strategy with use of GP IIb/IIIa inhibitors • Bivalirudin is an acceptable substitute for either unfractionated heparin or enoxaparin • However, compared to either UFH/enoxaparin with GP IIb/IIIa inhibition or bivalirudin with GP IIb/IIIa inhibition • A bivalirudin alone strategy results in significantly greater net clinical benefit and enhanced survival free from adverse events at 30 days

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