Educational Program to Reduce Major Bleeding
Educational Program to Reduce Major Bleeding
Abciximab is a potent antiplate let agent that has been shown to significantly reduce ischemic complications in patients undergoing percutaneous coronary intervention (PCI). Abciximab reduces these complications by blocking the binding of fibrinogen to platelet glycoprotein IIb/IIIa receptors, the final common pathway of platelet aggregation. Because of this potent antiaggregation effect, abciximab has the potential to cause bleeding complications.
In the first large-scale clinical trial using abciximab in the setting of PCI, EPIC (Evaluation of 7E3 for the Prevention of Ischemic Complications), there was a significant reduction among abciximab recipients in the frequency of death, myocardial infarction (MI), and the need for revascularization compared with patients who received traditional therapy with aspirin plus heparin. Significantly more bleeding complications were seen with abciximab (14%) than with placebo (6.6%) (p = 0.001). Several factors, besides the use of abciximab, were thought to contribute to the bleeding in these patients. These factors included the lack of use of a weight-based heparin regimen during the procedure (nonweight-adjusted, 10,000-12,000 units as initial dose), heparin use for at least 12 hours after the procedure, and long indwelling sheath times (about 18 hours).
Evaluation of these safety factors was initially studied in a pilot trial called PROLOG (Precursor to EPILOG study). This small trial evaluated 103 patients receiving abciximab during PCI with a lower, weight-adjusted dosage of heparin, no heparin after the procedure, and shorter indwelling sheath times compared with the standard used in the EPIC trial. The PROLOG trial found that the elimination of postprocedural heparin reduced the frequency of bleeding. The impact of these changes was validated in the much larger clinical trial, EPILOG (Evaluation in PTCA to Improve Long-Term Outcomes with Abciximab). These changes successfully reduced the frequency of major bleeding to be comparable with the combination of aspirin and heparin (abciximab, 2% versus placebo, 3.1%) while preserving the clinical benefits of abciximab.
The results of the EPILOG trial were confirmed in a subsequent clinical trial using abciximab for patients undergoing PCI who were receiving coronary stents. The EPISTENT trial (Evaluation of Platelet IIb/IIIa Inhibition in Stenting) utilized the same safety procedures as the EPILOG trial to control bleeding. The results of the EPISTENT trial showed that major bleeding was not significantly higher than in the aspirin plus heparin control group (abciximab and stent, 1.5% versus placebo and stent, 2.2%).
An initial drug-use review of PCI patients receiving abciximab at our institution revealed an unacceptably high rate (14.3%) of major bleeding, which was very similar to the rate seen in the EPIC trial. We therefore evaluated the possibility that a clinical pharmacy-based educational program would decrease PCI-associated bleeding.
Abciximab is a potent antiplate let agent that has been shown to significantly reduce ischemic complications in patients undergoing percutaneous coronary intervention (PCI). Abciximab reduces these complications by blocking the binding of fibrinogen to platelet glycoprotein IIb/IIIa receptors, the final common pathway of platelet aggregation. Because of this potent antiaggregation effect, abciximab has the potential to cause bleeding complications.
In the first large-scale clinical trial using abciximab in the setting of PCI, EPIC (Evaluation of 7E3 for the Prevention of Ischemic Complications), there was a significant reduction among abciximab recipients in the frequency of death, myocardial infarction (MI), and the need for revascularization compared with patients who received traditional therapy with aspirin plus heparin. Significantly more bleeding complications were seen with abciximab (14%) than with placebo (6.6%) (p = 0.001). Several factors, besides the use of abciximab, were thought to contribute to the bleeding in these patients. These factors included the lack of use of a weight-based heparin regimen during the procedure (nonweight-adjusted, 10,000-12,000 units as initial dose), heparin use for at least 12 hours after the procedure, and long indwelling sheath times (about 18 hours).
Evaluation of these safety factors was initially studied in a pilot trial called PROLOG (Precursor to EPILOG study). This small trial evaluated 103 patients receiving abciximab during PCI with a lower, weight-adjusted dosage of heparin, no heparin after the procedure, and shorter indwelling sheath times compared with the standard used in the EPIC trial. The PROLOG trial found that the elimination of postprocedural heparin reduced the frequency of bleeding. The impact of these changes was validated in the much larger clinical trial, EPILOG (Evaluation in PTCA to Improve Long-Term Outcomes with Abciximab). These changes successfully reduced the frequency of major bleeding to be comparable with the combination of aspirin and heparin (abciximab, 2% versus placebo, 3.1%) while preserving the clinical benefits of abciximab.
The results of the EPILOG trial were confirmed in a subsequent clinical trial using abciximab for patients undergoing PCI who were receiving coronary stents. The EPISTENT trial (Evaluation of Platelet IIb/IIIa Inhibition in Stenting) utilized the same safety procedures as the EPILOG trial to control bleeding. The results of the EPISTENT trial showed that major bleeding was not significantly higher than in the aspirin plus heparin control group (abciximab and stent, 1.5% versus placebo and stent, 2.2%).
An initial drug-use review of PCI patients receiving abciximab at our institution revealed an unacceptably high rate (14.3%) of major bleeding, which was very similar to the rate seen in the EPIC trial. We therefore evaluated the possibility that a clinical pharmacy-based educational program would decrease PCI-associated bleeding.
Source...