Background: The direct thrombin inhibitor, bivalirudin, is associated with similar efficacy and superior safety in patients undergoing percutaneous coronary intervention. However, the role of direct thrombin inhibitors in carotid artery stenting is not well defined. The objective of this study was to compare the safety and effectiveness of bivalirudin and unfractionated heparin (UFH) for carotid artery stenting. We hypothesized that bivalirudin would be associated with less in-hospital postprocedure bleeding than UFH but similar rates of in-hospital and 30-day ischemic outcomes.
Methods and results: We compared the incidence of in-hospital hemorrhagic and in-hospital/30-day ischemic outcomes among patients in the CARE Registry who underwent carotid artery stenting between May 2005 and March 2012 using bivalirudin or UFH. Propensity score matching was used to obtain a balanced cohort of 3555 patients in each treatment group. Patients treated with bivalirudin had a significantly lower incidence of bleeding or hematoma requiring red blood cell transfusions (0.9% versus 1.5%; odds ratio, 0.57 [0.36-0.89]; P=0.01) when compared with UFH-treated patients. The incidence of in-hospital and 30-day ischemic outcomes, including death, myocardial infarction, stroke, transient ischemic attack, and the composite outcome, death/myocardial infarction/stroke, did not differ significantly between groups.
Conclusions: Bivalirudin was associated with lower rates of hemorrhagic outcomes compared with UFH during the index hospitalization for carotid artery stenting. In-hospital and 30-day ischemic events were similar between the 2 groups. Randomized comparisons of these agents are needed to confirm these findings.