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High-Dose, Double-Bolus Eptifibatide (Integrilin™) in Non- Urgent Coronary Stent Intervention 6 Month Results of the ESPRIT Trial
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6 Month Follow-up n Background: double-bolus, high-dose eptifibatide (Integrilin™) given as an adjunct to non-urgent coronary stent PCI in ESPRIT reduced the 1° endpoint (48° incidence of death, MI, urgent TVR, or bailout GP IIb/IIIa therapy) from 10.5% to 6.6% (37% RRR, p=0.0015) and the key 2° endpoint (30 day composite of death, MI, or urgent TVR) from 10.4% to 6.8% (35% RRR, p=0.0034). n Purpose: to determine 6 month outcomes of patients enrolled in the ESPRIT trial. n Follow-up: available in 98.5% of enrolled patients n Background: double-bolus, high-dose eptifibatide (Integrilin™) given as an adjunct to non-urgent coronary stent PCI in ESPRIT reduced the 1° endpoint (48° incidence of death, MI, urgent TVR, or bailout GP IIb/IIIa therapy) from 10.5% to 6.6% (37% RRR, p=0.0015) and the key 2° endpoint (30 day composite of death, MI, or urgent TVR) from 10.4% to 6.8% (35% RRR, p=0.0034). n Purpose: to determine 6 month outcomes of patients enrolled in the ESPRIT trial. n Follow-up: available in 98.5% of enrolled patients
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eptifibatide 180+180 µg/kg bolus (boluses 10 min apart) 2.0 µg/kg-min infusion x18-24° + heparin 60 U/kg bolus (ACT 200-300 sec) eptifibatide 180+180 µg/kg bolus (boluses 10 min apart) 2.0 µg/kg-min infusion x18-24° + heparin 60 U/kg bolus (ACT 200-300 sec) placebo+ placebo+ vs.vs. Study Design ASA, thienopyridine pre-rx; randomization in cath lab 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): death, MI 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): death, MI
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Key 6-Month Endpoint Cumulative Death, MI to 6 Months P=0.0015 35% log-rank statistic cumulative event rate (%)
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6-Month Efficacy Analysis Cumulative Events to 6 Months 9% P=NS 9% P=NS 33% P=0.0047 33% P=0.0047 35% P=0.0015 35% P=0.0015 22% P=0.0083 22% P=0.0083 43% P=NS 43% P=NS log-rank statistics cumulative event rate (%)
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Death, MI cumulative event rate (%) days p=0.0015 35% RRR p=0.0015 35% RRR 11.5% 7.5%
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Death, MI cumulative event rate (%) days p=0.0015 35% RRR p=0.0015 35% RRR 11.5% 7.45% placebo = 1.3% placebo = 1.3% eptifibatide = 1.1% eptifibatide = 1.1% 6.35% 10.2%
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age <658.77.514%0.43 6515.27.551%0.0002 6515.27.551%0.0002 <75 kg15.18.146%0.0065 75 to 90 kg12.17.736%0.045 >90 kg8.46.720%0.38 diabetes10.26.338%0.16 no diabetes11.87.735%0.0043 male10.37.428%0.048 female14.67.549%0.0065 stable angina7.36.95%0.84 ACS >2d11.76.148%0.0095 ACS <2d18.69.549%0.023 ST MI <7d20.511.544%0.23 6 Month Death or MI plac%ept%RRRp 0 0 1 1 2 2
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Death p=0.19 43% RRR p=0.19 43% RRR cumulative event rate (%) days 1.4% 0.8%
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Death p=0.19 43% RRR p=0.19 43% RRR 1.4% 0.8% cumulative event rate (%) days 0.4% 0.6% eptifibatide = 0.4% eptifibatide = 0.4% placebo = 0.8% placebo = 0.8%
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Death, MI, all TVR 18.3% 14.2% p=0.0083 22% RRR p=0.0083 22% RRR cumulative event rate (%) days
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Death, MI, all TVR p=0.0083 22% RRR p=0.0083 22% RRR 7.5% 11.0% eptifibatide = 6.7% eptifibatide = 6.7% placebo = 7.3% placebo = 7.3% cumulative event rate (%) days 18.3% 14.2%
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Target Vessel Revascularization 9.4% 8.6% p=0.51 8% RRR p=0.51 8% RRR placebo eptifibatide cumulative event rate (%) days
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Conclusions n Significant 35% reduction in the key 2° endpoint of death and MI at 6 months n Significant 22% reduction in the composite of death, MI and TVR at 6 months n Early (48 hr, 30 day) benefits sustained over time l continued separation of curves of composite endpoints, endpoint components over time n 43% (insignificant) reduction in mortality at 6 months n Significant 35% reduction in the key 2° endpoint of death and MI at 6 months n Significant 22% reduction in the composite of death, MI and TVR at 6 months n Early (48 hr, 30 day) benefits sustained over time l continued separation of curves of composite endpoints, endpoint components over time n 43% (insignificant) reduction in mortality at 6 months
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