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


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).


CONCLUSIONS
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.
Rassen
Jeremy A
JA
Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02120, USA. jrassen@post.harvard.edu
Mittleman
Murray A
MA
Glynn
Robert J
RJ
Alan Brookhart
M
M
Schneeweiss
Sebastian
S
D054058:Acute Coronary Syndrome / Q000401:mortality / Q000628:therapy*; D017130:Angioplasty / Q000379:methods*; D000991:Antithrombins / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D005260:Female; D006629:Hirudins / Q000009:adverse effects; D017052:Hospital Mortality; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000628:therapy*; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D014481:United States
D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; C074619:bivalirudin