For the HORIZONS AMI Investigators Impact of Baseline Renal Function on the Safety and Effectiveness of Bivalirudin in Patients with Acute MI Undergoing Primary Angioplasty: The HORIZONS AMI trial Roxana Mehran, Bernhard Witzenbichler, Giulio Guagliumi, Victor Guetta, Harry Suryapranata, Kurt Huber, Jochen Wöehrle, Chris Metzger, George Dangas, Helen Parise, Gregg W. Stone For the HORIZONS AMI Investigators

Background and Objectives In HORIZONS, bivalirudin monotherapy compared to heparin + GPI resulted in reduced rates of major bleeding and NACE, with comparable composite MACE in pts undergoing primary PCI. Whether the beneficial effects of Biv are independent of renal function, an important prognostic determinate after primary PCI, has not been reported. We evaluated 30-day outcomes overall and by randomized antithrombin treatment according to baseline renal function. Mehran et al ACC 2008

Baseline Characteristics CrCl ≥60 mL/min (N=2783) CrCl <60 mL/min (N=554) P-value Age (years) 57.9 [50.8, 65.5] 75.4 [70.4, 80.3] <0.0001 Male 81.1% 55.2% Diabetes 16.0% 19.3% 0.05 Hypertension 49.9% 69.1% Hyperlipidemia 42.2% 46.2% 0.08 Current smoking 50.4% 24.4% Prior MI 9.7% 15.3% Prior PCI 9.8% 13.9% 0.004 Prior CABG 2.3% 5.6% Mehran et al ACC 2008

30-Day Outcomes by Renal Function P<0.0001 for all *Not related to CABG **MACE = All cause death, reinfarction, ischemic TVR or stroke Mehran et al ACC 2008

30-Day Outcomes among Renally Impaired Patients (CrCl <60 mL/min) by Treatment *Not related to CABG **MACE = All cause death, reinfarction, ischemic TVR or stroke Mehran et al ACC 2008

30-Day Outcomes among Pts with Normal Renal Function (CrCl ≥60 mL/min) by Treatment *Not related to CABG **MACE = All cause death, reinfarction, ischemic TVR or stroke Mehran et al ACC 2008

Conclusions Patients with AMI and impaired renal function (CrCl <60 mL/min) undergoing primary PCI have significantly worse 30- day ischemic and bleeding outcomes compared to patients with normal renal function. There was no significant difference in 30-day outcomes among patients with impaired renal function treated with bivalirudin monotherapy or heparin + GPI in HORIZONS-AMI study. Among patients with normal renal function, bivalirudin monotherapy significantly reduces major bleeding and net adverse clinical events. Mehran et al ACC 2008