Economic Implications of the Use of Direct Thrombin Inhibitors in Percutaneous Coronary Intervention

More than 1.2 million percutaneous coronary intervention (PCI) procedures are performed each year in the United States, with average hospital costs of more than $10 000 per procedure. Balloon inflation and stent placement rupture atherosclerotic plaque and damage the vascular endothelium, both of which stimulate platelet activation and thrombus formation within the target vessel. Antiplatelet and antithrombin agents prevent thrombus formation in patients who undergo PCI and reduce the incidence of ischemic complications but require complex drug administration regimens and increase the cost of care. The results of the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE-2) clinical trial demonstrated that the direct thrombin inhibitor bivalirudin plus provisional glycoprotein (GP) IIb/IIIa inhibitor for selected patients could be used in place of a conventional strategy of heparin and routine use of a GP IIb/IIIa inhibitor, with no loss of efficacy and a significant reduction in the number of patients with bleeding complications. A subsequent economic analysis using data from 4651 patients who participated in REPLACE-2 and who were enrolled at study centers in the United States found that patients who were assigned to the bivalirudin and provisional GP IIb/IIIa inhibitor strategy had anticoagulation costs during PCI that were approximately $400 per patient lower than with heparin plus routine GP IIb/IIIa inhibition. Bivalirudin also produced corresponding decreases in total in-hospital costs and total treatment costs during the first 30 days after enrollment in the study. Despite improvements in antithrombin and antiplatelet therapies used in PCI, ischemic and bleeding complications are still common. In the REPLACE-2 study, bivalirudin was also associated with a decrease in the costs required to manage bleeding complications in PCI, whereas costs associated with ischemic complications were largely unchanged. In an economic analysis of the use of bivalirudin in 2 other clinical trials, bivalirudin was associated with decreases in the costs of treatment for ischemic and bleeding complications. The results of the REPLACE-2 trial thus suggest that conventional treatment with heparin and a GP IIb/IIIa inhibitor may be replaced by a strategy of bivalirudin and provisional GP IIb/IIIa inhibitor treatment for selected patients with similar effects on ischemic events, significantly reduced incidence of major bleeding complications, and lower overall cost. (Adv Stud Pharm. 2005;2(3):80-89)