Impact of gender on the safety and effectiveness of bivalirudin in patients with acute myocardial infarction undergoing primary angioplasty L Grinfeld, J Belardi, AJ Lansky, B Witzenbichler, G Guagliumi, K Zmudka, M Moeckel, A Ochala, W Ruzyllo, H Parise, R Mehran, GW Stone

Objectives To evaluate the impact of gender on the safety and effectiveness of bivaliridun monotherapy compared to UFH + the routine use of GP IIb/IIIa inhibitors in patients with AMI undergoing primary angioplasty: Similar or reduced rates of NACE at 30 days Similar or reduced rates of major bleeding Grinfeld et al ACC 2008

Demographics Male (N=2760) Female (N=842) p value Age (years) 58.8 [51.4, 67.8] 66.0 [57.1, 75.3] < 0.0001 BMI 27.1 [24.7, 30.0] 26.7 [24.0, 30.8] 0.2 Diabetes 15.8% 18.7% 0.05 Hypertension 50.8% 62.3% < 0 0001 Hyperlipidemia 42.1% 46.1% 0.04 Current smoking 47.8% 40.8% 0.0004 Prior MI 12.0% 7.4% 0.0002 Prior PCI 11.6% 7.9% 0.002 Prior CABG 3.3% 1.8% 0.03 Grinfeld et al ACC 2008

Events by gender Male (N=2760) Female (N=842) p value 1° Endpoint (MACE or major bleeding) 9.2% 15.6% < 0.0001 MACE (death, MI, ischemic TVR or stroke) 4.9% 7.4% 0.006 Death 2.2% 3.8% 0.01 Reinfarction 1.8% 2.1% 0.6 Stroke 0.6% 0.8% 0.5 Ischemic TVR 2.0% 3.4% 0.02 Major bleeding (Non-CABG related) 5.7% 10.1% < 0.001 Minor bleeding 7.8% 14.3% Grinfeld et al ACC 2008

Events by gender (male) RR=0.77 [0.59, 0.97] P=0.03 RR=0.59 [0.43, 0.82] P=0.001 P= ns Grinfeld et al ACC 2008

Events by gender (female) RR=0.76 [0.54, 1.08] P=0.01 RR=0.59 [0.38, 0.92] P=0.02 P= ns Grinfeld et al ACC 2008

Conclusions Women and men with AMI undergoing PCI have different risk profiles. Women have a higher incidence of death, ischemic TVR, major and minor bleeding. Despite these differences, bivalirudin monotherapy significantly reduces major bleeding and net adverse clinical events compared to UFH plus the routine use of GP IIb/IIIa inhibitors both in women and men. Grinfeld et al ACC 2008