Title: 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
1Impact of gender on the safety and effectiveness
of bivalirudin in patients with acute myocardial
infarction undergoing primary angioplastyL
Grinfeld, J Belardi, AJ Lansky, B Witzenbichler,
G Guagliumi, K Zmudka, M Moeckel, A Ochala, W
Ruzyllo, H Parise, R Mehran, GW Stone
2Objectives
- 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
3Demographics
Male (N2760) Female (N842) p value
Age (years) 58.8 51.4, 67.8 66.0 57.1, 75.3 lt 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 lt 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
4Events by gender
Male (N2760) Female (N842) p value
1 Endpoint (MACE or major bleeding) 9.2 15.6 lt 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 lt 0.001
Minor bleeding 7.8 14.3 lt 0.0001
Grinfeld et al ACC 2008
5Events by gender (male)
RR0.77 0.59, 0.97 P0.03
RR0.59 0.43, 0.82 P0.001
P ns
Grinfeld et al ACC 2008
6Events by gender (female)
RR0.76 0.54, 1.08 P0.01
RR0.59 0.38, 0.92 P0.02
P ns
Grinfeld et al ACC 2008
7Conclusions
- 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