title: Frequency and outcomes of provisional glycoprotein IIb/IIIa blockade in patients receiving bivalirudin during percutaneous coronary intervention.
abstract: OBJECTIVE
  This study sought to evaluate the frequency and efficacy of combination of bivalirudin and provisional glycoprotein (GP) IIb/IIIa blockade compared with bivalirudin monotherapy in current clinical practice of percutaneous coronary intervention (PCI) with drug-eluting stents (DES).
  
  
  BACKGROUND
  Previous randomized trials have demonstrated that a strategy of bivalirudin with provisional (bailout) GP IIb/IIIa inhibition was non-inferior to unfractionated heparin (UFH) plus planned GP IIb/IIIa blockade for the prevention of acute and long-term adverse clinical events. However, the frequency and efficacy of provisional GP IIb/IIIa inhibition in addition to the full-dose bivalirudin in current practice is not well established.
  
  
  METHODS
  Using the 2004/2005 Cornell Angioplasty Registry, we studied 1,340 consecutive patients undergoing urgent or elective PCI with periprocedural use of bivalirudin. We excluded patients presenting with an acute ST-elevation myocardial infarction (MI) within < or = 24 hours, hemodynamic instability/shock, thrombolytic therapy within < or = 7 days, or renal insufficiency. Mean clinical follow up was 24.2 +/- 7.7 months.
  
  
  RESULTS
  Of the study cohort, 1,184 patients (88.4%) received bivalirudin alone and 156 (11.6%) received bivalirudin plus bailout GP IIb/IIIa blockade. DES were used in 86% of PCIs. The incidence of in-hospital mortality (0% vs. 0.3% p = 1.000), MI (7.1% vs. 6.6%; p = 0.864), and the combined endpoint of death, stroke, emergent coronary artery bypass graft surgery (CABG)/PCI, or MI (7.1% vs. 6.9%; p = 0.868) were similar in the bivalirudin-plus-bailout GP IIb/IIIa inhibitor versus the bivalirudin-alone arm. There was a higher incidence of bleeding complications (16.0% vs. 9.6%; p = 0.018) in the bivalirudin-plus-bailout GP IIb/IIIa versus the bivalirudin-alone group. At follow up, there were 4 (2.6%) deaths in the bivalirudin-plus-GP IIb/IIIa inhibitor group versus 83 (7.0%) deaths in the bivalirudin-alone arm (HR 0.36, 95% confidence interval [CI] 0.13-0.98; p = 0.044). After multivariate Cox regression analysis, bailout GP IIb/IIIa use in addition to bivalirudin was associated with similar long-term survival when compared to bivalirudin monotherapy (HR 0.41, 95% CI 0.15-1.12; p = 0.081).
  
  
  CONCLUSIONS
  Provisional GP IIb/IIIa use in bivalirudin-treated patients is higher in contemporary non-emergent PCI practice than that seen in randomized trials and is associated with similar in-hospital ischemic events, but more frequent bleeding events. These data suggest that a strategy of bivalirudin monotherapy is preferable in order to reduce bleeding complications, and GP IIb/IIIa blockade should be reserved for patients with periprocedural complications in bivalirudin-treated patients undergoing PCI.
authors.affiliation: New York Presbyterian Hospital, Weill Cornell Medical College, Greenberg Division of Cardiology, 520 East 70th Street, Starr-434 Pavilion, New York, NY 10021, USA. dnf9001@med.cornell.edu
authors.forename: Dmitriy N
authors.initials: DN
authors.lastname: Feldman
authors.forename: S Chiu
authors.initials: SC
authors.lastname: Wong
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Bergman
authors.forename: Robert M
authors.initials: RM
authors.lastname: Minutello
mesh_terms: D000077284:Abciximab; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods*; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D000925:Anticoagulants / Q000627:therapeutic use*; D001241:Aspirin / Q000627:therapeutic use; D000077144:Clopidogrel; D004359:Drug Therapy, Combination; D004617:Embolism / Q000517:prevention & control*; D000077542:Eptifibatide; D005260:Female; D005500:Follow-Up Studies; D006629:Hirudins; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000627:therapeutic use*; D010455:Peptides / Q000627:therapeutic use; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D011994:Recombinant Proteins / Q000627:therapeutic use; D012042:Registries; D012044:Regression Analysis; D012189:Retrospective Studies; D013927:Thrombosis / Q000517:prevention & control*; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D000925:Anticoagulants; D006629:Hirudins; D007140:Immunoglobulin Fab Fragments; D010446:Peptide Fragments; D010455:Peptides; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D000077144:Clopidogrel; D000077542:Eptifibatide; D013988:Ticlopidine; D001241:Aspirin; C074619:bivalirudin; D000077284:Abciximab