Association of Prerandomization Anticoagulant Switching With Bleeding in the Setting of Percutaneous Coronary Intervention (A REPLACE-2 Analysis)

• Published in: The American journal of cardiology 2007-06, Vol.99 (12), p.1687-1690
• Main Authors: Gibson, C. Michael, MD, Ten, Yuli, MBBS, Murphy, Sabina A., MPH, Ciaglo, Lauren N., BA, Southard, Matthew C., BS, Lincoff, A. Michael, MD, Waksman, Ron, MD
• Format: Article
• Language: English
• Subjects: Angioplasty; Angioplasty, Balloon, Coronary - adverse effects; Antibodies, Monoclonal - adverse effects; Anticoagulants - adverse effects; Biological and medical sciences; Carbohydrates; Cardiology; Cardiology. Vascular system; Cardiovascular; Clinical outcomes; Clinical trials; Correlation analysis; Diseases of the cardiovascular system; Drug therapy; Health hazards; Hemorrhage - chemically induced; Heparin, Low-Molecular-Weight - adverse effects; Hirudins - adverse effects; Humans; Immunoglobulin Fab Fragments - adverse effects; Medical sciences; Peptide Fragments - adverse effects; Peptides - adverse effects; Platelet Aggregation Inhibitors - adverse effects; Platelet Glycoprotein GPIIb-IIIa Complex - antagonists & inhibitors; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Recombinant Proteins - adverse effects
• ISSN: 0002-9149; 1879-1913
• DOI: 10.1016/j.amjcard.2007.01.053

The REPLACE-2 trial of patients who underwent urgent or elective percutaneous coronary intervention (PCI) demonstrated a significantly lower bleeding risk with bivalirudin plus provisional glycoprotein IIb/IIIa inhibitor compared with unfractionated heparin with planned glycoprotein IIb/IIIa inhibitor. The goal of this analysis was to evaluate whether a hazard existed when unfractionated heparin or low-molecular-weight heparin was administered before study medication in the REPLACE-2 trial. The REPLACE-2 trial randomized 6,010 patients undergoing PCI to receive bivalirudin plus provisional glycoprotein IIb/IIIa inhibitor or unfractionated heparin plus planned glycoprotein IIb/IIIa inhibitor. The present study compared bleeding among patients treated with or without antithrombin therapy in the 48 hours before study treatment. Among patients treated with bivalirudin, there was no difference in protocol-defined major or minor bleeding, bleeding according to Thrombolysis In Myocardial Infarction criteria, or noncoronary artery bypass graft blood transfusions between the patients treated with versus without antithrombin therapy (p = NS). However, in patients treated with unfractionated heparin plus planned glycoprotein IIb/IIIa inhibitor, there was a significant increase in the composite of protocol-defined major or minor bleeding and in noncoronary artery bypass graft blood transfusions (p