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  1. Alistair Lindsay, Editor

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What should the role of bivalirudin be in the management of ACS?▸

The REPLACE-2 (Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events) trial showed that bivalirudin monotherapy, when compared with unfractionated heparin and glycoprotein (GP) IIb/IIIa inhibitors, led to similar rates of ischaemia and death in patients with stable or unstable angina undergoing percutaneous coronary intervention (PCI), but that rates of major and minor bleeding were significantly reduced. The ACUITY (Acute Catheterization and Urgent Intervention Strategy) trial was a prospective, randomised, multi-centre trial that compared a regimen of heparin and a glycoprotein IIb/IIIa inhibitor against bivalirudin plus a glycoprotein IIb/IIIa inhibitor or against bivalirudin alone in patients with moderate or high-risk acute coronary syndromes (ACS) undergoing an early invasive strategy. There were 13 819 patients with ACS randomised to one of these three antithrombotic regimens. The primary end points were a composite ischaemia end point (death, myocardial infarction or unplanned revascularisation for ischaemia), major bleeding, and the net clinical outcome (combination of composite ischaemia or major bleeding). Bivalirudin and a GP IIb/IIIa inhibitor, compared with heparin and a GP IIb/IIIa inhibitor, was associated with non-inferior 30-day rates of the composite ischaemia end point (7.7% and 7.3%, respectively), major bleeding (5.3% and 5.7%, respectively) and the net clinical outcome end point (11.8% and 11.7%, respectively). Bivalirudin alone, compared with heparin plus a GP IIb/IIIa inhibitor, was associated with a non-inferior rate of the composite ischemia end point (7.8% and 7.3%, respectively) and significantly reduced rates of major bleeding (3.0% v 5.7%, respectively; p<0.001) and the net clinical outcome end point (10.1% v 11.7%, respectively). Therefore, in this trial, when used alone, bivalirudin showed a slight non-significant increase in ischaemic events compared with heparin and GP IIb/IIIa used in conjunction, but the frequency of major bleeding events was significantly reduced, overall translating into a net clinical benefit for bivalirudin. What is its …

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