within 30 days, any stroke or structural CNS abnormality, uncontrolled hypertension, PT >1.2 times control, hematocrit <30%, platelet count <100,000/mm3, and pregnancy.
Patient age ranged from 24 to 89 (mean 60) years, and 75% were male. The patients were 92% Caucasian, 5% Black, and 3% Hispanic. Forty-one percent of the patients underwent PCI for ongoing ACS. Patients were randomly assigned to 1 of 3 treatment regimens, each incorporating a bolus dose initiated immediately prior to PCI followed by a continuous infusion lasting 20 to 24 hours: 1) 135-mcg/kg bolus followed by a continuous infusion of 0.5 mcg/kg/min of eptifibatide (135/0.5); 2) 135-mcg/kg bolus followed by a continuous infusion of 0.75-mcg/kg/min of eptifibatide (135/0.75); or 3) a matching placebo bolus followed by a matching placebo continuous infusion. Each patient received aspirin and an intravenous heparin bolus of 100 U/kg, with additional bolus infusions of up to 2000 additional units of heparin every 15 minutes to maintain an activated clotting time (ACT) of 300 to 350 seconds.
The primary endpoint was the composite of death, MI, or urgent revascularization, analyzed at 30 days after randomization in all patients who received at least 1 dose of study drug.
As shown in Table 4, each eptifibatide regimen reduced the rate of death, MI, or urgent intervention, although at 30 days, this finding was statistically significant only in the lower-dose eptifibatide group. As in the PURSUIT study, the effects of eptifibatide were seen early and persisted throughout the 30-day period.
Table 4 Clinical Events in the IMPACT II Study Placebo Eptifibatide (135/0.5) Eptifibatide (135/0.75)
n (%) n (%) n (%)
*
Kaplan-Meier estimate of event rate.
Patients 1285 1300 1286
Abrupt Closure 65(5.1%) 36(2.8%) 43 (3.3%)
P-value vs. placebo 0.003 0.030
Death, MI, or Urgent Intervention
24 hours 123 (9.6%) 86 (6.6%) 89 (6.9%)
P-value vs. placebo 0.006 0.014
48 hours 131 (10.2%) 99 (7.6%) 102 (7.9%)
P-value vs. placebo 0.021 0.045
30 days (primary endpoint) 149 (11.6%) 118 (9.1%) 128 (10.0%)
P-value vs. placebo 0.035 0.179
Death or MI
30 days 110 (8.6%) 89 (6.8%) 95 (7.4%)
P-value vs. placebo 0.102 0.272
6 months 151 (11.9%)* 136 (10.6%)* 130 (10.3%)*
P-value vs. placebo 0.297 0.182
ESPRIT (Enhanced Suppression of the Platelet IIb/IIIa Receptor with INTEGRILIN Therapy)
The ESPRIT study was a multicenter, double-blind, randomized, placebo-controlled study conducted in the United States and Canada that enrolled 2064 patients undergoing elective or urgent PCI with intended intracoronary stent placement. Exclusion criteria included MI within the previous 24 hours, ongoing chest pain, administration of any oral antiplatelet or oral anticoagulant other than aspirin within 30 days of PCI (although loading doses of thienopyridine on the day of PCI were encouraged), planned PCI of a saphenous vein graft or subsequent "staged" PCI, prior stent placement in the target lesion, PCI within the previous 90 days, a history of bleeding diathesis, major surgery within 6 weeks of treatment, gastrointestinal bleeding within 30 days, any stroke or structural CNS abnormality, uncontrolled hypertension, PT >1.2 times control, hematocrit <30%, platelet count <100,000/mm3, and pregnancy.
Patient age ranged from 24 to 93 (mean 62) years and 73% of pa |
