Early versus Delayed, Provisional Eptifibatide in Acute Coronary Syndromes

TIMI (Thrombolysis in Myocardial Infarction) Study Group, Brigham and Women's Hospital, Boston, MA 02115, USA.
New England Journal of Medicine (Impact Factor: 55.87). 04/2009; 360(21):2176-90. DOI: 10.1056/NEJMoa0901316
Source: PubMed


Glycoprotein IIb/IIIa inhibitors are indicated in patients with acute coronary syndromes who are undergoing an invasive procedure. The optimal timing of the initiation of such therapy is unknown.
We compared a strategy of early, routine administration of eptifibatide with delayed, provisional administration in 9492 patients who had acute coronary syndromes without ST-segment elevation and who were assigned to an invasive strategy. Patients were randomly assigned to receive either early eptifibatide (two boluses, each containing 180 microg per kilogram of body weight, administered 10 minutes apart, and a standard infusion > or = 12 hours before angiography) or a matching placebo infusion with provisional use of eptifibatide after angiography (delayed eptifibatide). The primary efficacy end point was a composite of death, myocardial infarction, recurrent ischemia requiring urgent revascularization, or the occurrence of a thrombotic complication during percutaneous coronary intervention that required bolus therapy opposite to the initial study-group assignment ("thrombotic bailout") at 96 hours. The key secondary end point was a composite of death or myocardial infarction within the first 30 days. Key safety end points were bleeding and the need for transfusion within the first 120 hours after randomization.
The primary end point occurred in 9.3% of patients in the early-eptifibatide group and in 10.0% in the delayed-eptifibatide group (odds ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P=0.23). At 30 days, the rate of death or myocardial infarction was 11.2% in the early-eptifibatide group, as compared with 12.3% in the delayed-eptifibatide group (odds ratio, 0.89; 95% CI, 0.79 to 1.01; P=0.08). Patients in the early-eptifibatide group had significantly higher rates of bleeding and red-cell transfusion. There was no significant difference between the two groups in rates of severe bleeding or nonhemorrhagic serious adverse events.
In patients who had acute coronary syndromes without ST-segment elevation, the use of eptifibatide 12 hours or more before angiography was not superior to the provisional use of eptifibatide after angiography. The early use of eptifibatide was associated with an increased risk of non-life-threatening bleeding and need for transfusion. ( number, NCT00089895.)

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Available from: Robert Giugliano, Oct 03, 2015
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    • "In addition, the optimal timing for the initiation of treatment with GPI in patients with ACS is still unclear. In the recently published EARLY ACS trial the early use was not superior to the provisional use of eptifibatide after coronary angiography in patients with NSTE-ACS [27]. "
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    • "Also, it resulted in higher rates of non-life-threatening bleeding and transfusions. Although the results of EARLY-ACS do not support a strategy of routine early eptifibatide use in high-risk NSTE ACS patients managed with an invasive strategy it is possible that a subgroup of patients who have a low risk of bleeding may be considered for early eptifibatide use [4]. "
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