title: Femoral vascular closure device use, bivalirudin anticoagulation, and bleeding after primary angioplasty for STEMI: results from the HORIZONS-AMI trial.
abstract: OBJECTIVE
  To assess the relationship of femoral vascular closure device (VCD) use to bleeding and ischemic events in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) via different anticoagulation strategies.
  
  
  BACKGROUND
  It is unknown whether femoral VCD reduce major bleeding after primary PCI for STEMI using bivalirudin anticoagulation.
  
  
  METHODS
  We compared VCD-treated patients with propensity-matched controls in the HORIZONS-AMI trial with respect to net adverse clinical events (NACE), defined as the composite of major bleeding unrelated to coronary artery bypass graft surgery (CABG) and major adverse cardiac events (comprised of death, reinfarction, ischemia-driven target vessel revascularization, and stroke), at 30 days and 1 year.
  
  
  RESULTS
  Among 3,602 patients enrolled in HORIZONS-AMI, 2,948 underwent primary PCI via femoral arterial access and 896 (30%) received VCDs, of whom 642 were included in our model along with 642 propensity-matched controls. At 30 days, VCD-treated patients had significantly less NACE (6.7% vs. 10.8%, HR: 0.61, 95% CI: 0.42-0.89, P = 0.009), driven by a lower rate of non-CABG related major bleeding (5.0% vs. 8.1%, HR: 0.61, 95% CI: 0.39-0.94, P = 0.02). Bleeding reduction was maintained at one year and consistent in magnitude regardless of randomization to bivalirudin or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (P for interaction = 0.84).
  
  
  CONCLUSIONS
  In patients undergoing transfemoral primary PCI for STEMI, VCD use was associated with significantly lower non-CABG major bleeding irrespective of anticoagulation strategy.
authors.affiliation: NorthShore University HealthSystem, Evanston, Illinois.
authors.forename: Timothy A
authors.initials: TA
authors.lastname: Sanborn
authors.forename: Matthew I
authors.initials: MI
authors.lastname: Tomey
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Philippe
authors.initials: P
authors.lastname: Généreux
authors.forename: Bernhard
authors.initials: B
authors.lastname: Witzenbichler
authors.forename: Sorin J
authors.initials: SJ
authors.lastname: Brener
authors.forename: Ajay J
authors.initials: AJ
authors.lastname: Kirtane
authors.forename: Thomas C
authors.initials: TC
authors.lastname: McAndrew
authors.forename: Ran
authors.initials: R
authors.lastname: Kornowski
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.forename: Eugenia
authors.initials: E
authors.lastname: Nikolsky
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000379:methods / Q000401:mortality; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D005260:Female; D005263:Femoral Artery; D006470:Hemorrhage / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D006493:Heparin / Q000627:therapeutic use; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D057216:Propensity Score; D011677:Punctures; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012008:Recurrence; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D065506:Vascular Closure Devices
chemical_list: D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin
keywords: ST-segment elevation myocardial infarction; bivalirudin; heparin; primary percutaneous coronary intervention; vascular closure device