Coronary artery diseasePredictors and Impact of Major Hemorrhage on Mortality Following Percutaneous Coronary Intervention from the REPLACE-2 Trial
Section snippets
Study protocol
The methods of REPLACE-2 have been reported.3 In this double-blind active-controlled trial, patients undergoing elective or urgent PCI were randomly assigned to 1 of 2 antithrombotic strategies: heparin (65-U/kg bolus, maximum 7,000 U) plus abciximab (0.25-mg/kg bolus, 0.125-μg/kg/min [maximum 10 μg/min] infusion for 12 hours) or eptifibatide (2 boluses of 180 μg/kg 10 minutes apart, 2.0-μg/kg/min infusion for 18 hours; heparin plus GPI group) versus bivalirudin (0.75-mg/kg bolus,
Baseline and periprocedural predictors of major hemorrhage
Of 6,001 patients from REPLACE-2, a total of 195 (3.2%) experienced a major hemorrhage. Univariable analysis indicated that a number of baseline and periprocedural factors were associated with major hemorrhage (Table 1). Multivariable analysis identified baseline predictors of major hemorrhage that included age ≥75 years, female gender, previous angina, anemia, and impaired creatinine clearance. A second multivariable analysis using periprocedural and baseline data showed that randomization to
Discussion
This comprehensive analysis of major hemorrhagic complications associated with elective or urgent PCI in the REPLACE-2 Trial indicated that (1) several baseline and periprocedural factors were independent predictors of major hemorrhage; (2) major hemorrhage was a powerful independent predictor of 1-year mortality; and (3) randomization to the heparin plus GPI group was an independent predictor of major hemorrhage.
This was the first prospective randomized trial to compare 2 active antithrombotic
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REPLACE-2 was supported by a grant from The Medicines Company, Parsippany, New Jersey.