title: Efficacy and safety of bivalirudin in patients receiving clopidogrel therapy after diagnostic angiography for percutaneous coronary intervention in acute coronary syndromes.
abstract: OBJECTIVE
  This study sought to investigate if the efficacy of bivalirudin monotherapy is similar to heparin plus GP IIb/IIIa inhibition in patients with acute coronary syndromes (ACS) treated with clopidogrel following diagnostic angiography.
  
  
  BACKGROUND
  Prior trials have demonstrated that peri-procedural bivalirudin therapy confers similar efficacy as heparin plus GP IIb/IIIa inhibitors, while lowering the risk of bleeding complications in ACS patients undergoing percutaneous coronary interventions (PCI). However, the incidence of adverse ischemic events post-PCI appeared to be higher in patients receiving bivalirudin without adequate pretreatment with clopidogrel.
  
  
  METHODS
  Using the 2004/2005 Cornell Angioplasty Registry, we evaluated 980 consecutive patients undergoing urgent PCI for UA/NSTEMI who were treated with either bivalirudin or UFH plus GP IIb/IIIa inhibitor. We excluded patients who were on chronic clopidogrel therapy or received clopidogrel pretreatment prior to angiography. All patients received a clopidogrel load (≥300-mg dose) immediately before or after the PCI. Long-term all-cause mortality was obtained for 100% of patients, with a mean follow-up of 24.6 ± 7.7 months.
  
  
  RESULTS
  Of the 980 study patients, 461 (47.0%) were treated with bivalirudin and 519 (53.0%) patients received UFH plus GP IIb/IIIa inhibitor. DES were used in 88% of PCI; 45% of patients presented with NSTEMI. The incidence of in-hospital death (0.4% vs. 0.2%, P = 0.604), post-procedural MI (6.9% vs. 5.4%, P = 0.351), and MACE including death, stroke, emergent CABG/PCI, and MI (7.6% vs. 5.8%, P = 0.304) were similar in patients treated with bivalirudin versus UFH plus GP IIb/IIIa inhibitors, respectively. The incidence of in-hospital stent thrombosis was similar (0.7% vs. 0%, P = 0.104), while major (0.9% vs. 2.9%, P = 0.034) and minor bleeding (10.4% vs. 18.9%, P < 0.001) was reduced in the bivalirudin-treated group. By two-years of follow-up, after propensity-score adjusted multivariate Cox regression analysis, there was no significant difference in long-term mortality between the two groups (HR 1.18; 95%CI 0.64-2.19, P = 0.598).
  
  
  CONCLUSIONS
  In patients presenting with ACS and receiving clopidogrel treatment after angiography (before or within 30 min of PCI), peri-procedural bivalirudin monotherapy suppresses acute and long-term adverse events to a similar extent as does UFH plus GP IIb/IIIa inhibitors, while significantly lowering the risk of bleeding complications.
authors.affiliation: Greenberg Division of Cardiology, New York Presbyterian Hospital, Weill Cornell Medical College, New York, New York 10021, USA. dnf9001@med.cornell.edu
authors.forename: Dmitriy N
authors.initials: DN
authors.lastname: Feldman
authors.forename: Robert M
authors.initials: RM
authors.lastname: Minutello
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Bergman
authors.forename: Issam
authors.initials: I
authors.lastname: Moussa
authors.forename: S Chiu
authors.initials: SC
authors.lastname: Wong
mesh_terms: D054058:Acute Coronary Syndrome / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000401:mortality; D000991:Antithrombins / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D000077144:Clopidogrel; D017023:Coronary Angiography; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006331:Heart Diseases / Q000209:etiology / Q000517:prevention & control; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control; D006493:Heparin / Q000008:administration & dosage; D006629:Hirudins / Q000008:administration & dosage* / Q000009:adverse effects; D017052:Hospital Mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009519:New York City; D016017:Odds Ratio; D010446:Peptide Fragments / Q000008:administration & dosage* / Q000009:adverse effects; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D057216:Propensity Score; D016016:Proportional Hazards Models; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D020521:Stroke / Q000209:etiology / Q000517:prevention & control; D013988:Ticlopidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; D000077144:Clopidogrel; D013988:Ticlopidine; C074619:bivalirudin