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Comparison of Eptifibatide Plus Heparin vs. Bivalirudin in PCI: Impact on Hemorrhagic Complications

This study examines the risk of major and minor hemorrhagic complications in patients with normal renal function undergoing percutaneous coronary intervention (PCI) using eptifibatide plus heparin versus bivalirudin. The findings suggest that eptifibatide plus heparin increases the risk of hemorrhagic complications compared to bivalirudin.

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Comparison of Eptifibatide Plus Heparin vs. Bivalirudin in PCI: Impact on Hemorrhagic Complications

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  1. Eptifibatide plus HeparinIncreases the Risk of Major and Minor Hemorrhagic Complications Compared to Bivalirudinin Patients with Normal Renal Function Undergoing Percutaneous Coronary InterventionMichael C. McDaniel1, Reza Fazel1, Michele D. Voeltz1, Frederick Feit2, A. Michael Lincoff3, Steven V. Manoukian11Emory University School of Medicine, Atlanta, GA2New York University School of Medicine, New York, NY3The Cleveland Clinic, Cleveland, OH

  2. Relevant Conflict of Interest Statement I have no financial interests/arrangement to disclose.

  3. Hemorrhagic Complications with Normal Renal Function in PCI:Background • Excess dosing of eptifibatide and heparin • occurs more frequently with impaired renal function • increases the risk of hemorrhagic complications • Bivalirudin reduces hemorrhagic complications • compared to eptifibatide plus heparin • whether this benefit is attenuated with normal renal function, where excess dosing is less likely, is unknown • We assessed the risk of bleeding complications in patients with normal renal function undergoing PCI.

  4. Background: The CRUSADE ACS Registry Excess Dosing of Anticoagulants and Major Bleeding Alexander KP et al. JAMA 2005;294:3108-3116.

  5. Background: The REPLACE-2 TrialPredictors of One-Year Mortality in PCI Feit F, Voeltz MD, Attubato MA, et al. Unpublished.

  6. Background: The REPLACE-2 TrialMajor Bleeding is Increased with Eptifibatide or Abciximab vs. Bivalirudin in PCI p=0.0021 p=0.0251 4.1% 4.0% 2.5% 2.2% Voeltz MD, Lincoff AM, Feit F, Manoukian SV. Circulation 2005;112(17):II-737.

  7. Hemorrhagic Complications with Normal Renal Function in PCI:Hypothesis In patients with normal renal function undergoing PCI, in whom excess dosing is less likely, bivalirudin plus provisional eptifibatide is associated with lower rates of hemorrhagic complications compared to eptifibatide plus heparin.

  8. Hemorrhagic Complications with Normal Renal Function in PCI:Methods: REPLACE-2 Bivalirudin + Provisional GPIIb/IIIa inhibitor N=2994 Endpoints: 30-day Death MI Revasc Hemorrhage 6, 12m follow up N=6002 Urgent or Elective PCI patients Eptifibatide or Abciximab + Heparin N=3008 N=812 Bivalirudin + provisional Eptifibatide N=3317 Eptifibatide Cohort N=1648 Eptifibatide Cohort With CrCl >90 mL/min Endpoints: 30-day Death MI Revasc Hemorrhage 6, 12m follow up N=836 Eptifibatide + Heparin Lincoff AM et al. JAMA 2003;289:853-863.

  9. Hemorrhagic Complications with Normal Renal Function in PCI:Bleeding Definitions: REPLACE-2 • Major Bleeding • Intracranial, intraocular, or retroperitoneal • Overt bleed with fall in Hgb >3g/dL • Any decrease in Hgb >4g/dL • Transfusion 2 units PRBC or whole blood • Minor Bleeding • Overt bleeding that did not meet major bleeding criteria

  10. Hemorrhagic Complications with Normal Renal Function in PCI:Results: Baseline Characteristicsof the Eptifibatide Cohort with CrCl >90 mL/min

  11. Hemorrhagic Complications with Normal Renal Function in PCI:Results: Ischemic Event Rates in the Eptifibatide Cohort with CrCl >90 mL/min P=NS for all 6.6% 6.1% 5.7% 4.6% 1.7% 0.9%

  12. Hemorrhagic Complications with Normal Renal Function in PCI:Results: Mortality in the Eptifibatide Cohort with CrCl >90 mL/min P=NS for all 0.7% 0.6% 0.4% 0% 0% 0.2%

  13. Hemorrhagic Complications with Normal Renal Function in PCI:Results: Minor Bleedingin the Eptifibatide Cohort with CrCl >90 mL/min p<0.0001 23.7% 11.0%

  14. Hemorrhagic Complications with Normal Renal Function in PCI:Results: Major Bleedingin the Eptifibatide Cohort with CrCl >90 mL/min p=0.0056 2.9% 1.0%

  15. Hemorrhagic Complications with Normal Renal Function in PCI:Results: Major Bleeding with Age <75in the Eptifibatide Cohort with CrCl >90 p=0.0025 2.9% 0.9%

  16. Hemorrhagic Complications with Normal Renal Function in PCI:Results: Major Bleeding by CrClin the Overall Eptifibatide Cohort 33% Reduction 46% Reduction 5.2% 4.1% 66% Reduction 3.5% 2.9% 2.2% 1.0% Overall Cohort P=0.0021 CrCl >90 P=0.0055 CrCl <90 P=0.099

  17. Hemorrhagic Complications with Normal Renal Function in PCI:Conclusions • Hemorrhagic complications are more frequent with eptifibatide plus heparin compared to bivalirudin plus provisional eptifibatide in patients with normal renal function undergoing PCI. • These findings imply that the increase in hemorrhagic risk with eptifibatide plus heparin cannot be attributed to excess dosing.

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