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

https://doi.org/10.1016/j.amjcard.2007.06.026Get rights and content

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.

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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.

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