Effectiveness and safety of bivalirudin during percutaneous coronary intervention in a single medical center

Am J Cardiol. 2005 Mar 15;95(6):716-21. doi: 10.1016/j.amjcard.2004.11.021.

Abstract

A recent large-scale, randomized trial demonstrated the noninferiority of a strategy of bivalirudin with provisional glycoprotein (GP) IIb/IIIa inhibition compared with routine GP IIb/IIIa inhibition. There is a paucity of outcome data with bivalirudin use in the setting of real-world experience. We evaluated 6,996 patients who underwent percutaneous coronary intervention between January 2001 and December 2004 to compare early and late outcomes with a bivalirudin-based antithrombotic regimen with those with a heparin-based regimen. Propensity adjustment was performed to correct for baseline differences in patient characteristics. Bivalirudin-based therapy was used in 1,070 patients, heparin only in 801 patients, and heparin plus GP IIb/IIIa inhibitors in 5,125 patients. Compared with patients who received heparin or those who received heparin plus GP IIb/IIIa inhibitors, patients who received bivalirudin had lower incidences of bleeding (blood transfusion rate 1.7% vs 4.0%, p <0.001) and periprocedural myonecrosis (creatine kinase-MB >5 times the upper limit of normal 2.7% vs 4.3%, p = 0.016). Differences in bleeding end points remained significant after adjusting for the propensity to receive bivalirudin, but there was no difference in ischemic events. There was no difference in unadjusted long-term survival rate (log-rank test p = 0.46, total number of deaths 412, mean follow-up 17 months) or in propensity-adjusted long-term survival rate (hazard ratio 1.37, 95% confidence interval 0.90 to 2.08, p = 0.14). Compared with heparin with or without GP IIb/IIIa inhibition, the use of bivalirudin in a large consecutive patient registry at a tertiary care center was associated with fewer bleeding events and no evident increase in the incidence of ischemic complications.

Publication types

  • Comparative Study

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary*
  • Cohort Studies
  • Coronary Restenosis / mortality
  • Coronary Restenosis / therapy
  • Coronary Stenosis / therapy*
  • Creatine Kinase / blood
  • Creatine Kinase, MB Form
  • Drug Therapy, Combination
  • Female
  • Fibrinolytic Agents / administration & dosage*
  • Fibrinolytic Agents / adverse effects
  • Follow-Up Studies
  • Hemorrhage / chemically induced
  • Heparin / administration & dosage
  • Heparin / adverse effects
  • Hirudins / administration & dosage*
  • Hirudins / adverse effects
  • Hirudins / analogs & derivatives*
  • Humans
  • Isoenzymes / blood
  • Male
  • Middle Aged
  • Myocardial Infarction / mortality
  • Myocardial Infarction / therapy
  • Ohio
  • Peptide Fragments / administration & dosage*
  • Peptide Fragments / adverse effects
  • Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors
  • Prospective Studies
  • Recombinant Proteins / administration & dosage*
  • Recombinant Proteins / adverse effects
  • Survival Analysis
  • Treatment Outcome

Substances

  • Fibrinolytic Agents
  • Hirudins
  • Isoenzymes
  • Peptide Fragments
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Recombinant Proteins
  • Heparin
  • Creatine Kinase
  • Creatine Kinase, MB Form
  • bivalirudin