title: Arteriotomy closure device safety after percutaneous coronary intervention in the direct thrombin inhibitor era: a comparative study.
abstract: OBJECTIVE
  To investigate the safety and risk of vascular complications of arteriotomy closure devices (ACD) with the direct thrombin inhibitor bivalirudin in patients undergoing percutaneous coronary intervention (PCI).
  
  
  BACKGROUND
  ACDs and manual compression have been shown to have a similar risk of complications in the setting of PCI with heparin ± glycoprotein (GP) IIb/IIIa inhibitor usage. In many centers bivalirudin is becoming the most frequent type of anticoagulation used during PCI. We sought to determine the risk of vascular complications using Angio-Seal, Perclose, and manual compression for groin hemostasis using predominantly bivalirudin.
  
  
  METHODS
  Our institution's interventional database retrospectively identified 14,354 consecutive patients undergoing PCI from 2000 to 2008. Patients were grouped by the adjunctive anticoagulation used (bivalirudin vs. heparin + GP IIb/IIIa inhibitors) as well as ACD employed. The incidence of complications was evaluated using multivariable analysis to account for baseline differences between groups.
  
  
  RESULTS
  Patients undergoing PCI with adjunctive bivalirudin had significantly fewer complications overall, regardless of closure method (2.9% vs. 8.7%, P < 0.001). The Perclose group had significantly fewer complications than the Angio-Seal and manual compression groups (3.9% vs. 5.6% vs. 9.0%, P < 0.001) respectively; the Angio-Seal group had significantly fewer complications than manual compression. Multivariable analysis also identified age ≥ 65, female gender, BMI ≤ 26, and operator as independent predictors of complications.
  
  
  CONCLUSIONS
  The use of adjunctive bivalirudin during PCI was associated with fewer vascular complications. In addition, the Perclose and Angio-Seal devices had significantly fewer complications than manual compression and women ≥ 65 are at highest risk.
authors: Cleveland Clinic, Cleveland, Ohio 44195, USA.
authors: Gus
authors: G
authors: Theodos
authors: Chad
authors: C
authors: Raymond
authors: Matthew C
authors: MC
authors: Becker
authors: Julie
authors: J
authors: Thornton
authors: Stephen G
authors: SG
authors: Ellis
authors: Deepak L
authors: DL
authors: Bhatt
authors: Russell E
authors: RE
authors: Raymond
mesh_terms: D000367:Age Factors; D000368:Aged; D000991:Antithrombins / Q000009:adverse effects*; D015992:Body Mass Index; D016009:Chi-Square Distribution; D004867:Equipment Design; D005260:Female; D006119:Groin / Q000098:blood supply*; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation*; D006493:Heparin / Q000009:adverse effects; D006629:Hirudins / Q000009:adverse effects*; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D010446:Peptide Fragments / Q000009:adverse effects*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects*; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects; D011677:Punctures; D011994:Recombinant Proteins / Q000009:adverse effects; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D012737:Sex Factors; D016896:Treatment Outcome
chemical_list: D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin