Tolerability and feasibility of eptifibatide in acute coronary syndrome in patients at high risk for cardiovascular disease: A retrospective analysis.

BACKGROUND

Despite the beneficial effects of glycoprotein (GP) IIb/IIIa antagonists in patients with unstable angina and non-ST-segment elevation myocardial infarction (UA/NSTEMI), GP IIb/IIIa antagonists are rarely administered in general internal medicine wards in Israel, where most patients with UA/ NSTEMI are admitted, due to lack of adequate monitoring and safety concerns.

OBJECTIVE

The aims of this study were to compare the prevalence of bleeding complications in patients with UA/NSTEMI receiving combination treatment with eptifibatide (a GP IIb/IIIa antagonist), the low-molecular-weight heparin enoxaparin, and acetylsalicylic acid (ASA) versus that in patients receiving enoxaparin and ASA in internal medicine wards in Israel, and to identify risk factors for bleeding complications.

METHODS

This retrospective analysis included information from the database at Rambam Medical Center, Haifa, Israel. The database provided information from 4 of the 5 wards (the ward from which data were unavailable did not routinely use eptifibatide). Data were included from patients aged ≥l.8 years who were admitted to the center with a diagnosis of UA/NSTEMI, were at high risk for death and/or nonfatal ischemic events based on American College of Cardiology/American Heart Association guidelines, were to undergo coronary intervention, and who had a Thrombosis in Myocardial Infarction risk score ≥3 (moderate to high risk). Patients in the eptifibatide group received eptifibatide IV (180-μg/kg bolus followed by a continuous infusion of 2 μg/kg · min up to 72 hours), enoxaparin SC (2 mg/kg · d), and ASA (100 mg/d). Patients in the control group received enoxaparin SC (2 mg/kg - d up to 96 hours) and ASA (100 mg/d). The prevalence of bleeding events was assessed using data up to 24 hours after the end of study drug administration. Major bleeding was defined as life-threatening bleeding at any site, intracranial hemorrhage, or bleeding accompanied by a decrease in plasma hemoglobin concentration of 5 g/dL or more. Otherwise, bleeding was considered minor. The risk for bleeding events was assessed using multivariate regression analysis.

RESULTS

Data from 105 patients (64 men, 41 women) were included in the analysis. In the eptifibatide and control groups, the mean (SD) ages were 68.7 (11.1) and 74.8 (11.0) years, respectively. These characteristics were statistically similar between the 2 groups. The rates of major bleeding were similar between the eptifibatide and control groups (2 [3.8%] vs 0 patients). The rate of minor bleeding was significantly higher in the eptifibatide group compared with that in controls (11 [21.2%] vs 4 [7.5%] patients; P = 0.03). The incidence of thrombocytopenia was statistically similar between the eptifibatide and control groups (0 vs 2 [3.8%] patients). The risk for bleeding was found to be associated with eptifibatide use (odds ratio, 4.8; 95% CI, 1.29-17.80), whereas an association with treatment was not found in the control group.

CONCLUSION

The results of this retrospective analysis suggest that the risk for bleeding complications is higher with combination treatment with eptifibatide, enoxaparin, and ASA compared with that with enoxaparin and ASA in high-risk patients with UA/NSTEMI admitted to internal medicine wards in Israel.