Abstract 4312: Routine Use of Bivalirudin Reduces Bleeding and Increases Ischemic Complications During Percutaneous Coronary Intervention
Introduction: Unfractionated heparin (UFH) is widely accepted as the cornerstone of antithrombotic therapy during percutaneous coronary intervention (PCI). However, variable bioavailability, platelet activation, risk of heparin-induced thrombocytopenia and provisional use of glycoprotein IIb/IIIa inhibitors (GPI) pose limitations to its utility. Direct thrombin inhibitors, notably bivalirudin, have been described as a viable alternative to UFH. Randomized controlled trials have shown that bivalirudin is associated with non-inferior rates of clinical composite endpoints, reduced major bleeding and in some cases a lower 30-day death rate compared to UFH plus GPI.
Hypothesis: We assessed the hypothesis that the routine use of bivalirudin is associated with lower bleeding complications without increasing major ischemic endpoints or death.
Methods: From Jan 1, 2006 to Jan 31, 2007, 5,214 consecutive patients received UFH plus GPI or selective bivalirudin; from Feb 1, 2007 to Feb 29, 2008, 4,737 patients received routine bivalirudin during PCI at the Mount Sinai Hospital in New York. Patients were prospectively followed one year for the development of bleeding, ischemic complications and death.
Results: The routine use of bivalirudin reduced vascular and bleeding complications (6.1% vs. 4.3%, p<0.001) while it increased periprocedural ischemic complications (3.6% vs. 4.9%, p<0.001). The 1-year mortality rate was similar in both groups (3.0% vs. 3.4%, p=0.28). The 30-day combined ischemic endpoint (MACE) was significantly higher in the routine group (3.2% vs. 4.2%, p=0.008). However, 30-day MACE combined with major bleeding was similar in both groups (8.9% vs. 8.1%, p=0.16) owing to the lower rate of bleeding in the routine group.
Conclusions: In conclusion, bivalirudin, as compared with UFH plus GPI, reduced major bleeding and vascular complications and increased ischemic complications at 30 days with a similar 1-year mortality.