Bivalirudin is a direct thrombin inhibitor that will be available in the UK in November 2004 as adjunctive anticoagulant therapy during percutaneous coronary intervention (PCI). Its mechanism of action offers potential advantages over heparin in terms of both efficacy and bleeding. Bivalirudin is convenient – ACT monitoring is unnecessary, infusion is only for the duration of the procedure, and half-life is short so that early sheath removal and ambulation are possible. Finally, bivalirudin may offer major cost savings over glycoprotein (GP) IIb/IIIa inhibitors. The REPLACE-2 trial demonstrated equivalent efficacy and reduced bleeding with bivalirudin alone versus heparin-plus-GP IIb/IIIa inhibition in 6,010 patients undergoing elective or urgent PCI (30-day MACE 7.6% vs. 7.1%, major bleeding 2.4% vs. 4.1%). Further trials are underway to evaluate the efficacy of bivalirudin during PCI for high-risk acute coronary syndromes (ACS) and acute myocardial infarction (AMI).
This paper considers when bivalirudin should be used in contemporary PCI. The ISAR-REACT study provides firm evidence that heparin alone is safe and effective for elective PCI in low-to-moderate risk patients (30 day MACE 4% heparin-alone vs. 4% abciximab). Patients with AMI or unstable ACS were not included in the REPLACE-2 trial and should continue to receive GP IIb/IIIa inhibitors until further data are available. Bivalirudin could be considered in patients at intermediate risk in whom GP IIb/IIIa inhibitors are currently widely used, including during complex elective PCI, elective PCI in diabetics, and in patients with stabilised or low-risk ACS. Bivalirudin will also have a specific role in patients at increased risk of bleeding and with heparin-induced thrombocytopaenia. Further data are required before more widespread adoption of bivalirudin can be recommended.
For UK healthcare professionals only