1. The ESPRIT Trial 6 Month and 1 Year Results
James E. Tcheng, MD, FACC, FSCAI
Duke Clinical Research Institute
Duke University Medical Center
Durham, NC

2. Eptifibatide Integrilin® (COR Therapeutics)
Mpr - Har - Gly - Asp - Trp - Pro - Cys - C - NH2
constrained KGD cyclic heptapeptide
Mpr = mercaptopropionyl, Har = homoarginyl
derived from venom of Sistrurus m barbouri
IV agent, blocks GP IIb/IIIa integrin
half-life of 2–2.5 hours

3. Study Design eptifibatide 180+180 µg/kg bolus placebo
ASA, thienopyridine <24°; randomization in cath lab
eptifibatide µg/kg bolus
(boluses 10 min apart) 2.0 µg/kg-min infusion x18-24° +
heparin 60 U/kg bolus (ACT sec)
placebo +
heparin 60 U/kg bolus (ACT sec)
vs.
elective (non-urgent) stent PCI
48 hour, 30 day, 6 month, 1 year follow-up
primary endpoint: 48° death, MI, urgent TVR, thrombotic bailout
key secondary endpoint (30d): death, MI, urgent TVR
key secondary endpoint (6m, 1y): death, MI

4. Eptifibatide with ADP / PPACK Inhibition of Platelet Aggregation
Study Drug Infusion
IMPACT II
% baseline aggregation
135 / 0.75
PURSUIT
180 / 2.0
20%
180 / 2.0 / 180
ESPRIT
time

5. Key 6-Month Endpoint Cumulative Death, MI to 6 Months
cumulative event rate (%)
P=0.0015
37%
log-rank statistic

6. cumulative event rate (%)
6 Month Death, MI, all TVR
cumulative event rate (%)
18.5%
p=0.0072
26% RRR
14.3%
days

7. cumulative event rate (%)
1 Year Death, MI
cumulative event rate (%)
37% RRR
p=0.0010
12.4%
8.0%
months

8. cumulative event rate (%)
1 Year Death, MI
cumulative event rate (%)
37% RRR
p=0.0010
 = 0.9%
 = 0.6%
30d-1yr
=2.2%
=1.7%
12.4%
11.5%
7.4%
10.2%
6.3%
 = 1.3%
 = 1.1%
8.0%
months

9. cumulative event rate (%)
1 Year Death, MI, all TVR
cumulative event rate (%)
22.1%
17.5%
24% RRR
p=0.0068
months

10. cumulative event rate (%)
1 Year TVR by Diabetes
18.1%
cumulative event rate (%)
=2.0%
10% RR
p=NS
16.1%
11.6%
=1.2%
11% RR
p=NS
10.4%
months

11. ESPRIT Long-Term Follow-up
Significant  in primary (48 hr) and key (30 day) composite endpoints
consistent RRR across all components, subgroups
Significant  in composite 6 mo and 1 yr endpoints
Early (48 hr, 30 day) benefits sustained over time
continued separation of curves of composite endpoints between 30 days and 1 year
separation of curves driven by reductions in death and TVR (MI curves remain parallel)
Early mortality benefit maintained to 1 year
Effects consistent between diabetics, non-diabetics