Bivalirudin in patients undergoing primary percutaneous coronary intervention for acute ST-elevation myocardial infarction: outcomes in a large real-world population

EuroIntervention. 2013 May 20;9(1):118-24. doi: 10.4244/EIJV9I1A17.


Aims: 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.

Methods and 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.

Publication types

  • Observational Study

MeSH terms

  • Aged
  • Antithrombins / administration & dosage
  • Antithrombins / adverse effects
  • Antithrombins / therapeutic use*
  • Coronary Thrombosis / etiology
  • Coronary Thrombosis / prevention & control
  • Drug Administration Schedule
  • Female
  • Hemorrhage / chemically induced
  • Hirudins / administration & dosage
  • Hirudins / adverse effects
  • Humans
  • Logistic Models
  • Male
  • Middle Aged
  • Myocardial Infarction / mortality
  • Myocardial Infarction / therapy*
  • Odds Ratio
  • Peptide Fragments / administration & dosage
  • Peptide Fragments / adverse effects
  • Peptide Fragments / therapeutic use*
  • Percutaneous Coronary Intervention* / adverse effects
  • Percutaneous Coronary Intervention* / mortality
  • Prospective Studies
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / adverse effects
  • Recombinant Proteins / therapeutic use
  • Risk Factors
  • Time Factors
  • Treatment Outcome


  • Antithrombins
  • Hirudins
  • Peptide Fragments
  • Recombinant Proteins
  • bivalirudin