Safety of Concomitant Therapy with Eptifibatide and Enoxaparin in Patients Undergoing Percutaneous Coronary Intervention: Results of the Coronary Revascularization using Integrilin and Single Bolus Enoxaparin Study. - Safety of Concomitant Therapy with Eptifibatide and Enoxaparin in Patients Undergoing Percutaneous Coronary Intervention: Results of the Coronary Revascularization using Integrilin and Single Bolus Enoxaparin Study.

Jan 19, 2003
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Date Presented:
01/01/2003
Date Published:
01/01/2003
Date Updated:
01/19/2003
Original Posted Date:
01/19/2003
References

Description:

The goal of this study was to assess whether use of enoxaparin during percutaneous coronary intervention (PCI) increased bleeding compared with unfractionated heparin, when used on top of background therapy with eptifibatide.

Study Design

Study Design:

Patients Enrolled: 261

Primary Endpoints:

bleeding index, defined as the fall in hemoglobin (g/dl) over the first 24 h, adjusted for whole blood or red blood cell transfusions (prehemoglobin - post hemoglobin + units transfused).

Drug/Procedures Used:

This was an open-label randomized clinical trial. A total of 261 patients undergoing elective or urgent PCI were randomized to either eptifibatide plus enoxaparin or eptifibatide plus unfractionated heparin. The primary end point was the bleeding index, defined as the fall in hemoglobin (g/dl) over the first 24 h, adjusted for whole blood or red blood cell transfusions (prehemoglobin - post hemoglobin + units transfused).

Principal Findings:

The primary end point of the study, the bleeding index (change in hemoglobin corrected for blood transfusions), was 0.8 in the patients randomized to enoxaparin and 1.1 in patients randomized to unfractionated heparin (p = 0.15). The rate of vascular access site complications was 9.3% in the enoxaparin arm versus 9.8% in the unfractionated heparin arm (p = NS). The rate of bleeding complications was not significantly different between the two arms of the study, including in those patients who received vascular closure devices. The rate of angiographic complications was 6.3% in the enoxaparin group and 6.2% in the unfractionated heparin group (p = NS). Similarly, there were no significant differences in the composite of death, myocardial infarction, or urgent target vessel revascularization at 48 h or 30 days.

Interpretation:

Among patients undergoing elective or urgent PCI the combination of enoxaparin plus eptifibatide is not associated with an excess of bleeding or vascular complications, including those receiving closure devices, compared to unfractionated heparin plus eptifibatide. Despite no monitoring of anticoaglulation activity with enoxaparin, there was no apparent increase in angiographic or clinical complications. Data from this trial suggests that use of enoxaparin or unfractionated heparin with concomitant GP IIb/IIIa inhibition with eptifibatide during elective or urgent PCI have similar bleeding rates, as measured by the bleeding index. The trial however did not show any other clinical benefit associated with enoxaparin compared to unfractionated heparin in this setting. Several large randomized clinical trials including SYNERGY should help define the role of enoxaparin in the PCI setting. The additional benefit of monitoring anti Xa levels during enoxaparin therapy requires further assessment.

References:

Bhatt DL, Lee BI, Casterella PJ, et al. Safety of Concomitant Therapy with Eptifibatide and Enoxaparin in Patients Undergoing Percutaneous Coronary Intervention: Results of the Coronary Revascularization using Integrilin and Single Bolus Enoxaparin Study. J Am Coll Cardiol 2003;41:20-25.

Keywords: Myocardial Infarction, Hemoglobins, Erythrocyte Transfusion, Enoxaparin, Heparin, Low-Molecular-Weight, Platelet Membrane Glycoprotein IIb, Percutaneous Coronary Intervention, Platelet Glycoprotein GPIIb-IIIa Complex


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