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European Heart Journal Advance Access published online on November 25, 2009
European Heart Journal, doi:10.1093/eurheartj/ehp437
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2009. For permissions please email: journals.permissions@oxfordjournals.org

Safety and effectiveness of bivalirudin in routine care of patients undergoing percutaneous coronary intervention

Jeremy A. Rassen1,2,*, Murray A. Mittleman2,3, Robert J. Glynn1,4, M. Alan Brookhart1 and Sebastian Schneeweiss1,2

1 Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120, USA
2 Department of Epidemiology, Harvard School of Public Health, Boston, MA, USA
3 Beth Israel Deaconess Medical Center, Boston, MA, USA
4 Department of Biostatistics, Harvard School of Public Health, Boston, MA, USA

Received 27 April 2009; revised 2 September 2009; accepted 25 September 2009 * Corresponding author. Tel: +1 917 399 6555, Fax: +1 617 232 8602, Email: jrassen{at}post.harvard.edu

Aims: To evaluate the effectiveness and safety of bivalirudin as used in routine care. Bivalirudin has been studied as an alternative to heparin plus glycoprotein IIb/IIIa inhibitor (GPI) during percutaneous coronary intervention (PCI). Trials have indicated that bivalirudin is non-inferior to heparin with respect to death and repeat revascularization and may decrease the risk of major bleeds. The use of bivalirudin in routine care has not been evaluated.

Methods and results: Using a representative database, we identified 127 185 individuals who underwent inpatient PCI between June 2003 and December 2006 and were administered either bivalirudin plus provisional GPI or the comparator, heparin plus GPI. We estimated relative risks of blood transfusion, repeated PCI, and in-hospital death. The adjusted hazard ratio (HR) for blood transfusion was 0.67 (0.61–0.73); instrumental variable analysis showed an HR of 0.72 (0.12–4.47). We observed a risk of in-hospital death of 0.80% in the bivalirudin group and 2.1% in the heparin group; the adjusted HR was 0.51 (0.44–0.60).

Conclusion: In our non-randomized study of routine care, we observed a reduction in blood transfusions and in short-term mortality for patients treated with bivalirudin compared with heparin plus GPI. The mortality benefit was more pronounced in our study than in randomized trials.

Key Words: Anti-thrombotic treatments • Pharmacoepidemiology • Instrumental variable analysis • Confounding factor (epidemiology) • Percutaneous coronary intervention


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