August 10, 2004JAMA
Long-term Efficacy of Bivalirudin and Provisional Glycoprotein IIb/IIIa Blockade vs Heparin and Planned Glycoprotein IIb/IIIa Blockade During Percutaneous Coronary Revascularization<SUBTITLE>REPLACE-2 Randomized Trial</SUBTITLE>
Why the study?
Does bivalirudin with provisional Gp IIb/IIIa inhibition reduce death, myocardial infarction, or repeat revascularization compared to heparin with planned Gp IIb/IIIa inhibition in patients undergoing urgent or elective PCI?
Population
6010 patients undergoing urgent or elective PCI
Comparison
Intravenous bivalirudin with provisional Gp… vs Heparin with planned Gp IIb/IIIa inhibition…
Design
RCT, randomly assigned, double-blind
Follow-up
1 year
Authors
Discussion
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Member takes
Implication
Bivalirudin with provisional GP IIb/IIIa yields comparable 1-year mortality after PCI; extends 30-day noninferiority to longer-term outcomes.
Structured PICO
Does bivalirudin with provisional Gp IIb/IIIa inhibition reduce death, myocardial infarction, or repeat revascularization compared to heparin with planned Gp IIb/IIIa inhibition in patients undergoing urgent or elective PCI?
P
Population
6010 patients undergoing urgent or elective PCI
I
Intervention
Intravenous bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg per hour for the duration of PCI) with provisional Gp IIb/IIIa inhibition; both groups received daily aspirin and a thienopyridine for at least 30 days after PCI
C
Comparator
Heparin (65 U/kg bolus) with planned Gp IIb/IIIa inhibition (abciximab or eptifibatide); both groups received daily aspirin and a thienopyridine for at least 30 days after PCI
O
Outcome
Incidence of death, myocardial infarction, or repeat revascularization by 6 months and death by 12 months after enrollmentcomposite
Bivalirudin with provisional Gp IIb/IIIa blockade provides comparable long-term clinical outcomes up to 1 year compared to heparin plus planned Gp IIb/IIIa inhibition during contemporary PCI.
Cite This Study
A. Michael Lincoff (2004) studied this question.