Purpose of Technology: Anticoagulation is recommended for patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). Two commonly employed options include heparin and bivalirudin. Heparin is an indirect thrombin inhibitor; it binds and activates antithrombin and enhances its specificity for both thrombin and other coagulation factors. Unfractionated heparin, administered intravenously, demonstrates a highly variable dose-response relationship and requires hematologic monitoring during its use. Bivalirudin is a direct thrombin inhibitor that predictably inhibits the activity of both circulating and clot-bound thrombin, thereby reducing the risk for ischemic complications associated with PCIs.
Controversy: Bivalirudin carries a much higher upfront cost compared with heparin, and while it has been associated with lower rates of bleeding complications in ACS patients undergoing PCI, most studies comparing bivalirudin with heparin also include the use of glycoprotein IIb/IIIa inhibitors (GPIs), which carry their own risk for bleeding. The evidence is unclear as to whether bivalirudin is associated with a comparatively elevated risk for acute stent thrombosis.
How does bivalirudin compare with heparin monotherapy with regard to death, myocardial infarction, revascularization, and stroke, or a composite of these, and acute stent thrombosis, in ACS patients who undergo PCI?
How does bivalirudin compare with heparin monotherapy with regard to safety in ACS patients who undergo PCI?
Have definitive patient selection criteria been established for bivalirudin treatment during PCI?
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