Objectives: To explore the relative and absolute risks associated with various definitions for myocardial infarction, bleeding and revascularisation within the context of percutaneous coronary intervention(PCI). Metho...Objectives: To explore the relative and absolute risks associated with various definitions for myocardial infarction, bleeding and revascularisation within the context of percutaneous coronary intervention(PCI). Methods: The REPLACE-2(randomised evaluation of PCI linking Angiomax to reduced clinical events) database of patients undergoing PCI was used. Various definitions of myocardial infarction, bleeding and revascularisation were modelled by logistic regression assessing their relationship with 12-month mortality. Estimates from these models were used to calculate the “attributable fraction”for late mortality associated with each definition. Results: The most liberal definition of myocardial infarction was associated with an attributable risk of 13.7%(95%CI 3.4%to 23.0%). The most stringent definition was associated with an attributable risk of 4.6%(95%CI 0.6%to 8.6%). Restrictive definitions of bleeding such as TIMI(thrombolysis in myocardial infarction) major bleeding are associated with a high odds ratio of risk(6.1, 95%CI 2.1 to 17.7, p=0.001) but low attributable fraction(3.5%, 95%CI 0.9%to 6.8%). Conclusions: Stringent end point definitions may under-represent the clinical significance of adverse outcomes after PCI. Considering both the proportional and absolute risk associated with definitions may be a more useful method for evaluating clinical trial end points. This analysis supports the current definitions of ischaemic events but suggests that more liberal definitions of bleeding events may also be relevant to late mortality.展开更多
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Objectives: To explore the relative and absolute risks associated with various definitions for myocardial infarction, bleeding and revascularisation within the context of percutaneous coronary intervention(PCI). Methods: The REPLACE-2(randomised evaluation of PCI linking Angiomax to reduced clinical events) database of patients undergoing PCI was used. Various definitions of myocardial infarction, bleeding and revascularisation were modelled by logistic regression assessing their relationship with 12-month mortality. Estimates from these models were used to calculate the “attributable fraction”for late mortality associated with each definition. Results: The most liberal definition of myocardial infarction was associated with an attributable risk of 13.7%(95%CI 3.4%to 23.0%). The most stringent definition was associated with an attributable risk of 4.6%(95%CI 0.6%to 8.6%). Restrictive definitions of bleeding such as TIMI(thrombolysis in myocardial infarction) major bleeding are associated with a high odds ratio of risk(6.1, 95%CI 2.1 to 17.7, p=0.001) but low attributable fraction(3.5%, 95%CI 0.9%to 6.8%). Conclusions: Stringent end point definitions may under-represent the clinical significance of adverse outcomes after PCI. Considering both the proportional and absolute risk associated with definitions may be a more useful method for evaluating clinical trial end points. This analysis supports the current definitions of ischaemic events but suggests that more liberal definitions of bleeding events may also be relevant to late mortality.
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.
