PMID- 19494400 OWN - NLM STAT- MEDLINE DCOM- 20090930 LR - 20181201 IS - 1557-2501 (Electronic) IS - 1042-3931 (Linking) VI - 21 IP - 6 DP - 2009 Jun TI - Frequency and outcomes of provisional glycoprotein IIb/IIIa blockade in patients receiving bivalirudin during percutaneous coronary intervention. PG - 258-63 AB - OBJECTIVES: 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. FAU - Feldman, Dmitriy N AU - Feldman DN AD - 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 FAU - Wong, S Chiu AU - Wong SC FAU - Bergman, Geoffrey AU - Bergman G FAU - Minutello, Robert M AU - Minutello RM LA - eng PT - Journal Article PL - United States TA - J Invasive Cardiol JT - The Journal of invasive cardiology JID - 8917477 RN - 0 (Antibodies, Monoclonal) RN - 0 (Anticoagulants) RN - 0 (Hirudins) RN - 0 (Immunoglobulin Fab Fragments) RN - 0 (Peptide Fragments) RN - 0 (Peptides) RN - 0 (Platelet Aggregation Inhibitors) RN - 0 (Platelet Glycoprotein GPIIb-IIIa Complex) RN - 0 (Recombinant Proteins) RN - A74586SNO7 (Clopidogrel) RN - NA8320J834 (Eptifibatide) RN - OM90ZUW7M1 (Ticlopidine) RN - R16CO5Y76E (Aspirin) RN - TN9BEX005G (bivalirudin) RN - X85G7936GV (Abciximab) SB - IM CIN - J Invasive Cardiol. 2009 Jun;21(6):264-5. PMID: 19494401 MH - Abciximab MH - Aged MH - Aged, 80 and over MH - Angioplasty, Balloon, Coronary/adverse effects/*methods MH - Antibodies, Monoclonal/therapeutic use MH - Anticoagulants/*therapeutic use MH - Aspirin/therapeutic use MH - Clopidogrel MH - Drug Therapy, Combination MH - Embolism/*prevention & control MH - Eptifibatide MH - Female MH - Follow-Up Studies MH - Hirudins MH - Humans MH - Immunoglobulin Fab Fragments/therapeutic use MH - Male MH - Middle Aged MH - Peptide Fragments/*therapeutic use MH - Peptides/therapeutic use MH - Platelet Aggregation Inhibitors/therapeutic use MH - Platelet Glycoprotein GPIIb-IIIa Complex/*antagonists & inhibitors MH - Recombinant Proteins/therapeutic use MH - Registries MH - Regression Analysis MH - Retrospective Studies MH - Thrombosis/*prevention & control MH - Ticlopidine/analogs & derivatives/therapeutic use MH - Treatment Outcome EDAT- 2009/06/06 09:00 MHDA- 2009/10/01 06:00 CRDT- 2009/06/05 09:00 PHST- 2009/06/05 09:00 [entrez] PHST- 2009/06/06 09:00 [pubmed] PHST- 2009/10/01 06:00 [medline] PST - ppublish SO - J Invasive Cardiol. 2009 Jun;21(6):258-63.