Comparison of heparin and bivalirudin in patients undergoing percutaneous coronary intervention without use of glycoprotein IIb/IIIa inhibitors

OBJECTIVES: The primary objective of this study is the compare the association between bleeding and the use unfractionated heparin (UFH) versus bivalirudin during percutaneous coronary intervention (PCI). BACKGROUND: In patients undergoing PCI, the risk of bleeding with use of bivalirudin compared with UFH in the absence of glycoprotein IIb/IIIa inhibitors is not well defined. METHODS: Patients undergoing PCI with either UFH or bivalirudin monotherapy at a single institution between 2007 and 2014 were included (n = 6,143). Propensity score matching was used to adjust for baseline characteristics yielding 2,984 well matched patients (1,492 in each group). The primary endpoint was major non-coronary artery bypass graft (non-CABG) related bleeding as defined by a Bleeding Academic Consortium type 3 or 5. Secondary outcomes included combined major and minor bleeding, in-hospital death, periprocedural myocardial infarction, and recurrent ischemia requiring urgent revascularization (repeat PCI). RESULTS: In the propensity matched cohort, there was no difference in major bleeding between UFH and bivalirudin monotherapy (1.8% versus 2.4%, P = 0.305). Combined major and minor bleeding was also similar between the two groups (4.3% versus 4.3%, P = 1.0). Likewise, no differences were observed between the bivalirudin and UFH groups in terms of in-hospital death (0.4% versus 0.5%, P = 0.592), periprocedural myocardial infarction (1.5% versus 2.0%, P = 0.332) and repeat PCI (0.7% versus 0.8%, P = 0.669). CONCLUSION: Among patients undergoing PCI, there was no significant difference in rate of bleeding between bivalirudin and heparin monotherapy in a real-world setting.