Published at www.nejm.org March 30, 2009 (10.1056/NEJMoa0901316) |
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Published at www.nejm.org March 30, 2009 (10.1056/NEJMoa0901316) |
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Background 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.
Methods 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 µg per kilogram of body weight, administered 10 minutes apart, and a standard infusion
Results 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.
Conclusions 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. (ClinicalTrials.gov number, NCT00089895
[ClinicalTrials.gov]
.)
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 (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.
Source Information
From the TIMI (Thrombolysis in Myocardial Infarction) Study Group, Brigham and Women's Hospital, Boston (R.P.G., E.B.); Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (J.A.W., L.G.B., K.L.L., R.A.H., R.M.C., L.K.N.); Universitatsklinikum Freiburg, Freiburg, Germany (C.B.); University of Alberta, Edmonton, AB, Canada (P.W.A.); Centre Hospitalier Universitaire Pitié–Salpêtrière, Paris (G.M.); Lady Davis Carmel Medical Center, Haifa, Israel (B.S.L.); Isala Klinieken, Zwolle, the Netherlands (A.H.); Schering-Plough, Kenilworth, NJ (J.T.S., E.V.); Essex-Pharma, Munich, Germany (S.H.); and Universitair Ziekenhuis Gasthuisberg, Leuven, Belgium (F.V.W.).
This article (10.1056/NEJMoa0901316) was published at NEJM.org on March 30, 2009. It will appear in the May 21 issue of the Journal.
Address reprint requests to Dr. Giugliano at the TIMI Study Group, 350 Longwood Ave., First Fl., Boston, MA 02115, or at rgiugliano{at}partners.org.
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