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 inh...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. Although GP Ⅱb/Ⅲa inhibition has been shown to reduce ischemic complications in a broad range of patients undergoingPCI, 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. 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-upaccounting(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. Among the bivalirudin group, 7.7%required provisionalGP ⅡIb/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$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). 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.展开更多
文摘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. Although GP Ⅱb/Ⅲa inhibition has been shown to reduce ischemic complications in a broad range of patients undergoingPCI, 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. 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-upaccounting(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. Among the bivalirudin group, 7.7%required provisionalGP ⅡIb/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$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). 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.
