COST-EFFECTIVENESS AND CARDIAC INTERVENTIONS
Economic evaluation of bivalirudin with provisional glycoprotein IIB/IIIA inhibition versus heparin with routine glycoprotein IIB/IIIA inhibition for percutaneous coronary intervention
Results from the REPLACE-2 trial
David J. Cohen, MD, MSc*, ,*,
A. Michael Lincoff, MD ,
Tara A. Lavelle, BS,
Huei-Ling Chen, PhD,
Ameet Bakhai, MD*,,
Ronna H. Berezin, MPH,
Daniel Jackman, MD ,
Ian J. Sarembock, MB, ChB|| and
Eric J. Topol, MD
* Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
Harvard Clinical Research Institute, Brookline, Massachusetts, USA
Mother Frances Hospital, Tyler, Texas, USA
|| Cardiovascular Division and Cardiovascular Research Center, University of Virginia Health System, Charlottesville, Virginia, USA
Cleveland Clinic Foundation, Cleveland, Ohio, USA
Manuscript received February 3, 2004;
accepted May 11, 2004.
* Reprint requests and correspondence: Dr. David J. Cohen, Cardiovascular Division, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, Massachusetts 02215 (Email: dcohen{at}caregroup.harvard.edu).
OBJECTIVES: The purpose of this study was to compare the cost of percutaneous coronary intervention (PCI) using bivalirudin with provisional platelet glycoprotein (GP) IIb/IIIa inhibition with that of heparin + routine GP IIb/IIIa inhibition.
BACKGROUND: Although GP IIb/IIIa inhibition has been shown to reduce ischemic complications in a broad range of patients undergoing PCI, many patients currently do not receive such therapy because of concerns about bleeding complications or cost. Recently, bivalirudin with provisional GP IIb/IIIa inhibition has been validated as an alternative to heparin + routine GP IIb/IIIa inhibition for patients undergoing PCI. However, the cost-effectiveness of this novel strategy is unknown.
METHODS: In the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial, 4,651 U.S. patients undergoing non-emergent PCI were randomized to receive bivalirudin with provisional GP IIb/IIIa (n = 2,319) versus heparin + routine GP IIb/IIIa (n = 2,332). Resource utilization data were collected prospectively through 30-day follow-up on all U.S. patients. Medical care costs were estimated using standard methods including bottom-up accounting (for procedural costs), the Medicare fee schedule (for physician services), hospital billing data (for 2,821 of 4,862 admissions), and regression-based approaches for the remaining hospitalizations.
RESULTS: Among the bivalirudin group, 7.7% required provisional GP IIb/IIIa. Thirty-day ischemic outcomes including death or myocardial infarction were similar for the bivalirudin and GP IIb/IIIa groups, but bivalirudin resulted in lower rates of major bleeding (2.8% vs. 4.5%, p = 0.002) and minor bleeding (15.1% vs. 28.1%, p < 0.001). Compared with routine GP IIb/IIIa, in-hospital and 30-day costs were reduced by $405 (95% confidence interval [CI] $37 to $773) and $374 (95% CI $61 to $688) per patient with bivalirudin (p < 0.001 for both). Regression modeling demonstrated that, in addition to the costs of the anticoagulants themselves, hospital savings were due primarily to reductions in major bleeding (cost savings = $107/patient), minor bleeding ($52/patient), and thrombocytopenia ($47/patient).
CONCLUSIONS: Compared with heparin + routine GP IIb/IIIa inhibition, bivalirudin + provisional GP IIb/IIIa inhibition resulted in similar acute ischemic events and cost savings of $375 to $400/patient depending on the analytic perspective.
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Abbreviations and Acronyms
| | CABG = coronary artery bypass graft surgery | | CI = confidence interval | | CK-MB = creatine kinase-MB fraction | | GP = glycoprotein | | MI = myocardial infarction | | PCI = percutaneous coronary intervention | | REPLACE = Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events |
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