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Gregg W. Stone MD for the ACUITY Investigators

A Prospective, Randomized Trial of Bivalirudin in Acute Coronary Syndromes Final One-Year Results from the ACUITY Trial. Gregg W. Stone MD for the ACUITY Investigators. Medical management. UFH/Enox + GP IIb/IIIa (n=4,603). PCI. Bivalirudin + GP IIb/IIIa (n=4,604).

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Gregg W. Stone MD for the ACUITY Investigators

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  1. A Prospective, Randomized Trial of Bivalirudin in Acute Coronary SyndromesFinal One-Year Results from the ACUITY Trial Gregg W. Stone MD for the ACUITY Investigators

  2. Medical management UFH/Enox + GP IIb/IIIa (n=4,603) PCI Bivalirudin + GP IIb/IIIa (n=4,604) Angiography within 72h R* Bivalirudin Alone (n=4,612) CABG Study Design – First Randomization Moderate and high risk unstable angina or NSTEMI undergoing an invasive strategy (N = 13,819) 33% Moderate and high risk ACS (n=13,819) 56% Aspirin in all Clopidogrel dosing and timing per local practice 11% *Stratified by pre-angiography thienopyridine use or administration

  3. UFH/Enox + GP IIb/IIIa (N=4,603) GPI upstream (N=2294) GPI CCL for PCI (N=2309) Bivalirudin + GP IIb/IIIa (N=4,604) GPI upstream (N=2311) R* GPI CCL for PCI (N=2293) Bivalirudin Alone (N=4,612) Study Design – Second Randomization Moderate and high risk unstable angina or NSTEMI undergoing an invasive strategy (N = 13,819) Moderate and high risk ACS (n=13,819 Aspirin in all Clopidogrel dosing and timing per local practice *Stratified by pre-angiography thienopyridine use or administration

  4. 30 day P (log rank) 1 year P (log rank) Estimate Estimate p=0.55 UFH/Enoxaparin + IIb/IIIa 7.4% — 16.3% — 0.36 0.38 Bivalirudin + IIb/IIIa 7.8% 16.5% 0.34 0.31 Bivalirudin alone 7.9% 16.4% Ischemic Composite Endpoint(Death, MI, unplanned revascularization for ischemia) UFH/Enoxaparin + GPI vs. Bivalirudin + GPI vs. Bivalirudin Alone 25 20 15 Ischemic Composite (%) 10 H+GPI vs. Bivalirudin+GPI HR [95% CI] = 1.05 (0.94-1.16) 5 H+GPI vs. Bivalirudin alone HR [95% CI] = 1.05 (0.95-1.17) 0 0 30 60 90 120 150 180 210 240 270 300 330 360 390 Days from Randomization

  5. 30 day P (log rank) 1 year P (log rank) Estimate Estimate p=0.24 UFH/Enoxaparin + IIb/IIIa 4.4% — 6.2% — 0.69 0.63 Bivalirudin + IIb/IIIa 4.6% 6.4% 0.36 0.10 Bivalirudin alone 4.8% 7.1% Myocardial Infarction UFH/Enoxaparin + GPI vs. Bivalirudin + GPI vs. Bivalirudin Alone 15 10 MI (%) 5 0 0 30 60 90 120 150 180 210 240 270 300 330 360 390 Days from Randomization

  6. 30 day P (log rank) 1 year P (log rank) Estimate Estimate p=0.39 UFH/Enoxaparin + IIb/IIIa 2.3% — 8.6% — 0.20 0.17 Bivalirudin + IIb/IIIa 2.8% 9.5% 0.72 0.52 Bivalirudin alone 2.4% 8.9% Unplanned Revascularization UFH/Enoxaparin + GPI vs. Bivalirudin + GPI vs. Bivalirudin Alone 15 10 Unplanned Revasc. (%) 5 0 0 30 60 90 120 150 180 210 240 270 300 330 360 390 Days from Randomization

  7. Stent Thrombosis (Protocol Defn.) Drug-eluting Stent (DES) vs. Bare Metal Stent(BMS) 5 1 year P (log rank) Estimate BMS (N=2528) 2.3% 4 0.38 All (N=7158) 2.2% DES (N=4630) 2.2% 3 Stent Thrombosis (%) 2 1 0 0 30 60 90 120 150 180 210 240 270 300 330 360 390 Days from Randomization

  8. p=0.90 UFH/Enoxaparin + IIb/IIIa Bivalirudin + IIb/IIIa Bivalirudin alone P (log rank) 1 year P (log rank) Estimate Estimate 1.4% — 4.4% — 0.53 0.93 1.6% 4.2% 0.39 0.66 1.6% 3.8% Mortality: 524 total deaths at 1-year UFH/Enoxaparin + GPI vs. Bivalirudin + GPI vs. Bivalirudin Alone 5 H+GPI vs. Bivalirudin+GPI HR [95% CI] = 0.99 (0.80-1.21) 4 H+GPI vs. Bivalirudin alone HR [95% CI] = 0.95 (0.78-1.18) 3 Mortality (%) 2 1 0 0 30 60 90 120 150 180 210 240 270 300 330 360 390 Days from Randomization

  9. 4.8% 5.0% 1.04 (0.80-1.34) 2.4% 3.6% 0.84 (0.55-1.28) 3.5% 4.2% 0.90 (0.68-1.18) 4.0% 4.4% 1.05 (0.74-1.48) 3.2% 4.0% 0.95 (0.70-1.29) 6.8% 6.7% 1.03 (0.64-1.66) 4.0% 4.3% 0.95 (0.66-1.37) Death at 1-Year UFH/Enoxaparin + GPIIb/IIIa vs. Bivalirudin alone 1 yr KM estimate UFH/Enox + IIb/IIIa Hazard ratio ±95% CI Bival alone HR (95% CI) Pint Biomarkers (CK/Trop) Elevated (n=5072) Normal (n=3402) 0.40 Pre Thienopyridine Yes (n=5751) No (n=3305) 0.52 Actual Treatment PCI (n=5179) CABG (n=1040) Medical (n=2994) 0.96 Bivalirudin alone better UFH/Enox + IIb/IIIa better

  10. Major Bleed only (without MI) (N=551) 12.5% MI only (without Major Bleed) (N=611) 8.6% No MI or Major Bleed (N=12,557) Both MI and Major Bleed (N=94) 28.9% 3.4% p=0.04 Impact of MI and Major Bleeding (non-CABG) in the First 30 Days on Risk of Death Over 1 Year 1 yearEstimate 30 25 20 Mortality (%) 15 10 5 0 0 30 60 90 120 150 180 210 240 270 300 330 360 390 Days from Randomization

  11. Influence of Major Bleeding and MI in the First 30 Days on Risk of Death Over 1 Year Cox model adjusted for baseline predictors, with non-CABG major bleeding and MI as time-updated covariates HR ± 95% CI HR (95% CI) P-value

  12. Conclusions • In patients with moderate and high risk ACS undergoing an early invasive strategy with the use of GP IIb/IIIa inhibitors • Bivalirudin is an acceptable substitute for either unfractionated heparin or enoxaparin • Compared to either UFH/enoxaparin with GP IIb/IIIa inhibitors or bivalirudin with GP IIb/IIIa inhibitors • A bivalirudin alone strategy results in marked reduction of bleeding at 30 days, and similar rates of mortality and composite ischemia at 1-year • The results of this study further establish the important relationship between iatrogenic bleeding complications and the long-term prognosis in patients with ACS

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