title: Effectiveness and safety of bivalirudin during percutaneous coronary intervention in a single medical center.
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.
authors.affiliation: Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA.
authors.forename: Hitinder S
authors.initials: HS
authors.lastname: Gurm
authors.forename: Vivek
authors.initials: V
authors.lastname: Rajagopal
authors.forename: Robert
authors.initials: R
authors.lastname: Fathi
authors.forename: Deepak
authors.initials: D
authors.lastname: Vivekanathan
authors.forename: Jay S
authors.initials: JS
authors.lastname: Yadav
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Ellis
authors.forename: A Michael
authors.initials: AM
authors.lastname: Lincoff
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Topol
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D015331:Cohort Studies; D023903:Coronary Restenosis / Q000401:mortality / Q000628:therapy; D023921:Coronary Stenosis / Q000628:therapy*; D003402:Creatine Kinase / Q000097:blood; D052279:Creatine Kinase, MB Form; D004359:Drug Therapy, Combination; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000008:administration & dosage / Q000009:adverse effects; D006629:Hirudins / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D007527:Isoenzymes / Q000097:blood; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000628:therapy; D009820:Ohio; D010446:Peptide Fragments / Q000008:administration & dosage* / Q000009:adverse effects; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage* / Q000009:adverse effects; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D006629:Hirudins; D007527:Isoenzymes; D010446:Peptide Fragments; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; D003402:Creatine Kinase; D052279:Creatine Kinase, MB Form; C074619:bivalirudin