Carotid stenting and bivalirudin with and without vascular closure: 3‐year analysis of procedural outcomes

Abstract

This was a negative study, with no significant difference on prolonged hypotensive events in patients with vascular closure device and bivalirudin, compared with those with manual compression and bivalirudin. Vascular closure devices were safe and effective with a low incidence of complications. In carotid artery stenting, bivalirudin is safe with low incidence of major bleeding and acceptable 30-day adverse event rates (stroke and death).

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

“…Other cohort studies have also observed significant decreases in periprocedural bleeding and 30-day stroke rates among patients treated with bivalirudin when compared with UFH. 10,17,22 Although our findings are consistent with the aforementioned studies, our study was much larger, more representative (n=171 centers), incorporated various medical disciplines, used standard outcome definitions, involved prospective ascertainment of outcomes by independent observers, and involved more rigorous statistical techniques to adjust for potential selection bias and confounding. Collectively, the evidence base to date suggests that for CAS, bivalirudin is associated with fewer postprocedural hemorrhagic complications than UFH without an attendant increase in the risk of ischemic events.…”

“…[6][7][8][9] Although the relative safety of bivalirudin has been extensively studied in percutaneous coronary intervention, limited data are available comparing bivalirudin with UFH in CAS. 10,11 Although a small, single-center randomized study 11 demonstrated lower bleeding rates with bivalirudin compared with UFH among patients undergoing CAS, large-scale, real-world data regarding its comparative safety and effectiveness are currently lacking.…”

2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS Guideline on the Management of Patients With Extracranial Carotid and Vertebral Artery Disease

“…Bivalirudin may have advantages over heparin, including obviating the need for monitoring of activated clotting time. 607,608 CAS is associated with a number of periprocedural events, including hypotension and vasovagal and vasodepressor reactions. For this reason, continuous electrocardiogram and blood pressure monitoring has become routine.…”

Safety and Tolerability of High-Intensity Anticoagulation with Bivalirudin During Neuroendovascular Procedures

“…Bush et al [22] reported neither any major neurological sequelae nor hemorrhagic complications necessitating transfusion or operative intervention with adjuvant use of bivalirudin in over 150 patients who underwent carotid stent placement. Similarly, Schneider et al [23] reported their 3 year experience of using bivalirudin during carotid stent placement in 514 patients. In their series, major stroke and death occurred in 6 (1.1%) of patients within 30 days of procedure.…”