title: Clinical safety of bivalirudin in patients undergoing carotid stenting.
abstract: BACKGROUND
  Prior to June 2011, carotid artery stenting (CAS) had been limited to patients deemed high risk for surgical revascularization due to medical or anatomic reasons. Intraprocedural anticoagulation for CAS has traditionally been carried out with unfractionated heparin (UFH). The direct thrombin inhibitor bivalirudin has emerged as a possible alternative choice for anticoagulation in this patient population. In patients undergoing coronary interventions, bivalirudin has been shown in large prospective analysis to reduce major adverse events and hemorrhagic complications (TIMI major bleeding rates, 0.6%-3.1%; TIMI minor bleeding rates, 1.3%-3.7%). As of now, the safety and efficacy of bivalirudin for use during carotid stenting has not been rigorously evaluated. To date, the published evidence in favor of bivalirudin for CAS exists in small retrospective analyses and two prospective studies.
  
  
  METHODS
  We present a retrospective analysis of 331 patients with a total of 365 carotid artery lesions undergoing CAS between February 2007 and September 2010. The procedures were performed by five experienced operators from four separate sites within the same metropolitan area. Patients were included who received bivalirudin as the anticoagulation strategy and underwent CAS. The primary endpoints of the study were 30-day incidence of death, stroke, TIMI major bleeding (defined as ≥5 g/dL Hgb drop or intracranial hemorrhage), TIMI minor bleeding (defined as ≥3 g/dL Hgb drop), and blood transfusion. All data were collected by retrospective chart review.
  
  
  RESULTS
  A total of 365 CAS procedures were performed. There were no deaths, strokes, or TIMI major bleeds. There was a 2.19% incidence of TIMI minor bleeding (8/365) and a 1.64% rate of blood transfusion (6/365).
  
  
  CONCLUSIONS
  In our patient population, the major endpoints of stroke, death, MI, major and minor bleeding rates were well within those previously reported overall for carotid artery revascularization. Hence, we conclude that bivalirudin may be safe for use in CAS procedures with a safety profile similar to that validated in percutaneous coronary interventions.
authors.affiliation: Integris Baptist Medical Center, University of Oklahoma, Oklahoma City, Oklahoma 73112, USA.
authors.forename: Bryan D
authors.initials: BD
authors.lastname: Cogar
authors.forename: Siddharth A
authors.initials: SA
authors.lastname: Wayangankar
authors.forename: Mazen
authors.initials: M
authors.lastname: Abu-Fadel
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Hennebry
authors.forename: Mohammad K
authors.initials: MK
authors.lastname: Ghani
authors.forename: Robert M
authors.initials: RM
authors.lastname: Kipperman
authors.forename: George S
authors.initials: GS
authors.lastname: Chrysant
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000379:methods*; D000991:Antithrombins / Q000627:therapeutic use*; D002339:Carotid Arteries / Q000000981:diagnostic imaging; D016893:Carotid Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D006629:Hirudins; D006801:Humans; D008297:Male; D010446:Peptide Fragments / Q000627:therapeutic use*; D011859:Radiography; D011994:Recombinant Proteins / Q000627:therapeutic use; D012008:Recurrence; D012189:Retrospective Studies; D015607:Stents
chemical_list: D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; C074619:bivalirudin