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EARLY ACS
Early glycoprotein IIb/IIIa inhibition in non-ST-segment elevation Acute Coronary Syndrome
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Author(s) |
(a) Giugliano RP, Newby LK, Harrington RA, Gibson CM, Van de Werf F, Armstrong P, Montalescot G, Gilbert J, Strony JT, Califf RM, Braunwald E
(b) Giugliano RP, White JA, Bode C, Armstrong PW, Montalescot G, Lewis BS, van ‘t Hof A, Berdan LG, Lee KL, Strony JT, Hildemann S, Veltri E, Van de Werf F, Braunwald E, Harrington RA, Califf RM, Newby LK
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Title(s) |
(a) The Early Glycoprotein IIb/IIIa Inhibition in Non-ST-Segment Elevation Acute Coronary Syndrome (EARLY ACS) trial: a randomized placebo-controlled trial evaluating the clinical benefits of early front-loaded eptifibatide in the treatment of patients with non-ST-segment elevation acute coronary syndrome – Study design and rationale
(b) Early versus delayed, provisional eptifibatide in acute coronary syndromes
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Reference(s) |
(a) Am Heart J 2005;149:994–1002
(b) N Engl J Med 2009;360:2176–90
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Disease |
Acute coronary syndromes |
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Purpose |
To evaluate the efficacy and safety of early eptifibatide in patients with high-risk non-ST-segment elevation acute coronary syndrome |
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Study design |
Randomised, double-blind, placebo-controlled |
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Follow-up |
30 days |
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Patients |
9492 patients (4746 early eptifibatide, 4746 delayed eptifibatide), mean age 67 years, with high-risk unstable angina pectoris or non-ST-segment elevation MI, scheduled to undergo early invasive procedure |
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Treatment regimen |
Eptifibatide, 180 µg/kg iv bolus, then 2.0 µg/kg/min iv infusion, then second bolus 10 min later (early eptifibatide), or placebo, with delayed provisional eptifibatide |
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Concomitant therapy |
ASA, 162–325 mg orally or 150–500 mg iv, followed by ≥ 75 mg/day. Clopidogrel, 300–600 mg loading dose, followed by 75 mg/day. Unfractionated heparin or enoxaparin at the discretion of the physician |
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Results |
9406 patients (4772 early eptifibatide, 4684 delayed eptifibatide) were included in the intention-to-treat analysis. The primary composite endpoint of all-cause mortality, MI, recurrent ischaemia requiring urgent revascularisation or thrombotic bailout occurred in 9.3% of patients in the early eptifibatide group vs 10.0% in the delayed provisional administration group (odds ratio 0.92, 95% CI 0.80–1.06; p = 0.23). There was no significant difference between groups in the rate of severe bleeding (0.8% vs 0.9%; p = 0.97) |
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