1. 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

2. 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

3. Demographics Male (N=2760) Female (N=842) p value Age (years)
58.8 [51.4, 67.8]
66.0 [57.1, 75.3]
<
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%
<
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

4. Events by gender Male (N=2760) Female (N=842) p value
1° Endpoint (MACE or major bleeding)
9.2%
15.6%
<
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

5. 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

6. 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

7. 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