Bivalirudin Compares Favorably To Unfractionated Heparin During Carotid Artery Stenting

April 26, 2013—Findings from a study of hemorrhagic and ischemic outcomes after use of bivalirudin versus unfractionated heparin (UFH) during carotid artery stenting (CAS) were published by Siddharth A. Wayangankar, MD, et al in Circulation: Cardiovascular Interventions (2013;6:131–138). The study was a propensity-score analysis from the National Cardiovascular Data Registry (NCDR).

According to the investigators' conclusion in Circulation: Cardiovascular Interventions, bivalirudin was associated with lower rates of hemorrhagic outcomes compared to UFH during the index hospitalization for CAS, and in-hospital and 30-day ischemic events were similar between the two groups.

The background of the study noted that 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 CAS is not well defined. The objective of this study was to compare the safety and effectiveness of bivalirudin and UFH for CAS. The investigators 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.

The investigators compared the incidence of in-hospital hemorrhagic and in-hospital/30-day ischemic outcomes among patients in the NCDR's CARE registry who underwent CAS between May 2005 and March 2012 using bivalirudin or UFH. Propensity score matching was used to obtain a balanced cohort of 3,555 patients in each treatment group.

The investigators found that patients treated with bivalirudin had a significantly lower incidence of bleeding or hematoma requiring red blood cell transfusions (0.9% vs 1.5%; odds ratio, 0.57 [0.36–0.89]; P = .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 of death/myocardial infarction/stroke did not differ significantly between groups.

The investigators advised that randomized comparisons of these agents are needed to confirm these findings.