title: Bivalirudin in patients undergoing primary percutaneous coronary intervention for acute ST-elevation myocardial infarction: outcomes in a large real-world population.
abstract: OBJECTIVE
  Within a clinical trial population, direct thrombin inhibition using bivalirudin in patients undergoing primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) is associated with a reduction in mortality and major bleeding compared to heparin/glycoprotein IIb/IIIa receptor inhibition (GPI), but a higher incidence of acute stent thrombosis (ST), particularly in the absence of pre-procedural heparin. The safety and efficacy of bivalirudin in an all-comer, real-world primary PCI setting is unknown.
  
  
  RESULTS
  968 consecutive STEMI patients (mean age 63 years, 72% male, 42% anterior STEMI, 3.7% cardiogenic shock) undergoing primary PCI with bivalirudin as the recommended anticoagulation, and with heparin/GPI (abciximab) as an alternative, were prospectively followed. Bivalirudin was administered as a bolus, high-dose procedural infusion and, unlike the HORIZONS-AMI trial, as a low-dose infusion for four hours post-PCI. Additional heparin was not routinely given. Mortality, major adverse cardiovascular events (MACE), major bleeding and ST were assessed at 30 days. Initial antithrombotic therapy was bivalirudin in 885 patients (91%), of whom 123 (13.9%) received additional antithrombin therapy, and 114 (11.8%) "bail-out" GPI. Outcomes for bivalirudin-treated patients were; mortality 5.2%, MACE 7.5%, major bleeding 3.8%. The incidence of acute ST was 1.0%, including in the absence of additional heparin (1.2%). Most cases of acute ST (7/9) occurred in the first four hours post-PCI. There was no significant difference in outcomes between patients treated with bivalirudin versus heparin/GPI.
  
  
  CONCLUSIONS
  Routine use of bivalirudin in a real-world primary PCI population was associated with good 30-day outcomes. Acute stent thrombosis was infrequent, even without additional heparin. A continued low-dose infusion of bivalirudin did not appear to offer protection against very early stent thrombosis.
authors: Department of Cardiology, Leeds General Infirmary, Leeds, United Kingdom.
authors: Rhidian
authors: R
authors: Shelton
authors: Christos
authors: C
authors: Eftychiou
authors: Kathryn
authors: K
authors: Somers
authors: Alan
authors: A
authors: Liu
authors: Natalie
authors: N
authors: Burton-Wood
authors: Michelle
authors: M
authors: Anderson
authors: Loukia
authors: L
authors: Makri
authors: Jonathan
authors: J
authors: Blaxill
authors: James
authors: J
authors: McLenachan
authors: Stephen
authors: S
authors: Wheatcroft
authors: John
authors: J
authors: Greenwood
authors: Daniel
authors: D
authors: Blackman
mesh_terms: D000368:Aged; D000991:Antithrombins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003328:Coronary Thrombosis / Q000209:etiology / Q000517:prevention & control; D004334:Drug Administration Schedule; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006629:Hirudins / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000628:therapy*; D016017:Odds Ratio; D010446:Peptide Fragments / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000401:mortality; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; C074619:bivalirudin