Predictors and Impact of Major Hemorrhage on Mortality Following Percutaneous Coronary Intervention from the REPLACE-2 Trial

• Published in: The American journal of cardiology Vol. 100; no. 9; pp. 1364 - 1369
• Main Authors: Feit, Frederick, MD, Voeltz, Michele D., MD, Attubato, Michael J., MD, Lincoff, A. Michael, MD, Chew, Derek P., MBBS, Bittl, John A., MD, Topol, Eric J., MD, Manoukian, Steven V., MD
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.11.2007; Elsevier; Elsevier Limited
• Subjects: Aged; Angioplasty; Angioplasty, Balloon, Coronary - adverse effects; Angioplasty, Balloon, Coronary - mortality; Antithrombins - therapeutic use; Biological and medical sciences; Cardiology; Cardiology. Vascular system; Cardiovascular; Coronary Disease - mortality; Coronary Disease - therapy; Coronary heart disease; Diseases of the cardiovascular system; Female; Fibrinolytic Agents - therapeutic use; Glycoproteins; Heart; Hemorrhage; Hemorrhage - epidemiology; Hirudins; Humans; Intensive care; Logistic Models; Male; Medical sciences; Middle Aged; Mortality; Multivariate Analysis; Peptide Fragments - therapeutic use; Prospective Studies; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Recombinant Proteins - therapeutic use; Prognosis; Angioplasty; Predictor; Mortality; Coronary artery; Prediction; Instrumentation therapy; Cardiovascular disease; Coronary heart disease; Epidemiology; Hemorrhage; Phlebology; Stent; Clinical trial; Circulatory system; Cardiology; Predictive factor
• ISSN: 0002-9149; 1879-1913
• DOI: 10.1016/j.amjcard.2007.06.026

Patients undergoing percutaneous coronary intervention (PCI) have a significant risk of hemorrhagic complications. Predictors of major hemorrhage and its relation to mortality in PCI are not well defined. Baseline and periprocedural predictors of major hemorrhage and its impact on mortality in patients undergoing elective or urgent PCI randomly assigned to heparin plus planned glycoprotein IIb/IIIa inhibitor (GPI) versus bivalirudin plus provisional GPIs in the REPLACE-2 Trial were determined. Of 6,001 patients, 3.2% experienced a major hemorrhage. Independent baseline predictors of major hemorrhage included advanced age, female gender, impaired creatinine clearance, and anemia. Independent periprocedural predictors of major hemorrhage included treatment with heparin plus GPI, increased procedural duration, provisional use of GPI, increased time to sheath removal, length of intensive care unit stay, and use of an intra-aortic balloon pump (all p <0.05). Mortality rates were higher in patients with than without major hemorrhage at 30 days (5.1% vs 0.2%), 6 months (6.7% vs 1.0%), and 1 year (8.7% vs 1.9%; p <0.001 for all). Furthermore, major hemorrhage was an independent predictor of 1-year mortality (odds ratio 2.66, 95% confidence interval 1.44 to 4.92, p = 0.002). In conclusion, in patients undergoing elective or urgent PCI, major hemorrhage was an independent predictor of 1-year mortality. A number of baseline and periprocedural factors independently predicted major hemorrhage, including treatment with heparin plus GPI.