Original title: Hemorrhagic and ischemic outcomes after bivalirudin versus unfractionated heparin during carotid artery stenting: A propensity score analysis from the NCDR. Reference: Wayangankar SA et al. Circ Cardiovasc Interv. 2013;Epub ahead of print.
Bivalirudin is a direct thrombin inhibitor that has shown similar efficacy with a better safety profile in the context of coronary angioplasty. However, its role in carotid angioplasty is not well defined. The aim of this study was to compare the safety and efficacy of bivalirudin versus heparin sodium in carotid angioplasty with the hypothesis that this could decrease nosocomial bleeding complications with a similar rate of ischemic events. Patients in the bivalirudin group received a bolus of 0.75 mg/kg followed by a continuous infusion of 1.75 mg/kg/hour during the procedure while patients in the heparin group received doses according to the protocol of each center. Aspirin and clopidogrel were at the discretion of the surgeon.
10,560 patients from the CARE registry who underwent carotid angioplasty between 2005 and 2012 using bivalirudin or heparin sodium were included. The characteristics of the two groups were balanced using a propensity score, leaving 3,555 patients in each group for the final analysis. The bivalirudin group of patients had less bleeding or hematoma related to access requiring transfusion compared with the patients who received heparin, (0.9% versus 1.5% respectively, OR 0.57, CI 0.36 to 0.89, P = .01). Intra-cerebral hemorrhage rate was similar in both groups, (0.1% versus 0.2%, P = 0.41), as well as the composite of death, myocardial infarction or stroke, (2.1% versus 2.7%, P = .11).
Conclusion:
In the context of carotid angioplasty, bivalirudin was associated with a lower rate of bleeding complications compared with heparin sodium. The in-hospital ischemic events after 30 days were similar. A randomized study is needed to confirm these results.
Commentary:
Given the small margin we have in carotid angioplasty, each decrease in the rate of complications, however small, is helpful. The intra-cerebral bleeding rate was low in both groups, which is very important, first because of the morbidity and mortality of this complication and second because bivalirudin has no antidote and is not a problem in the context of intra-cerebral bleeding.
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