Hemorrhagic and Ischemic Outcomes After Bivalirudin Versus Unfractionated Heparin During Carotid Artery Stenting

Abstract

The objective of our study was to examine the incidence of in-hospital hemorrhagic and in-hospital and 30-day ischemic outcomes among patients in the CARE Registry who underwent CAS and were treated with either bivalirudin or UFH. We hypothesized that the use of bivalirudin for CAS would be associated 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. (Circ Cardiovasc Interv. 2013;6:131-138.)

Access Site Complications After Peripheral Vascular Interventions

“…The ENDOvascular interventions with angioMAX (ENDOMAX) trial may clarify the intrinsic risk of hemorrhagic complication difference between heparin and bivalirudin. 28 …”

Bivalirudin for Carotid Artery Stenting

“…The study by Wayangankar et al 21 has several strengths. These include its large size and use of standardized outcomes measures.…”

“…In this issue of Circulation: Cardiovascular Interventions, Wayangankar et al 21 report the outcomes of bivalirudin versus heparin as an anticoagulant during CAS among patients in the National Cardiovascular Data Registry-Carotid Artery Revascularization and Endarterectomy (NCDR-CARE) Registry. The study cohort included 10 560 patients, with 4135 patients (39%) treated with bivalirudin as the sole anticoagulant.…”

Management of anticoagulant-related intracranial hemorrhage: an evidence-based review

“…However, in the EINSTEIN-PE (Oral Rivaroxaban Alone for the Treatment of Symptomatic Pulmonary Embolism) trial – a study that compared the efficacy of rivaroxaban with that of enoxaparin followed by warfarin in patients with pulmonary embolism – the incidence of AICH was lower for rivaroxaban (0.1% vs. 0.5%; P  = 0.003) [32]. For cerebrovascular indication, national registry data showed similar peri-procedural incidence of ICH with bivalirudin and UFH after carotid stenting (0.1% vs. 0.2%; odds ratio = 0.62, 95% confidence interval = 0.20 to 1.91; P  = 0.41) [33]. …”