A large-scale study at 233 hospitals in nine countries indicates bivalirudin is as effective, with less bleeding, as heparin plus antiplatelet drugs during percutaneous coronary intervention (PCI). More than 6,000 patients undergoing urgent or elective stent, angioplasty or atherectomy procedures were evaluated in the study.
“Bivalirudin, with a glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibitor administered in approximately 7% of patients, provided protection from peri-procedural ischaemic events that was not inferior to that of the current standard of low-dose heparin plus planned Gp IIb/IIIa blockade, with less associated major haemorrhage,” report researchers led by Dr. Michael Lincoff of the Cleveland Clinic Foundation in Ohio, United States. “Bivalirudin with a provisional Gp IIb/IIa inhibitor was superior to heparin alone by an imputed comparison.” According to the investigators, these findings validate bivalirudin with selective Gp IIb/IIIa blockade “as an effective and safe anticoagulation strategy during PCI, with advantages with regard to bleeding risk, cost and ease of administration.”
Prior to this study, the direct thrombin inhibitor bivalirudin was not widely tested during contemporary percutaneous coronary intervention (PCI). ” Pre-specified statistical criteria for non-inferiority to heparin plus Gp IIb/IIIa were satisfied for both end points,” the researchers write. They point out that in-hospital major bleeding was significantly reduced with bivalirudin, at 2.4%, compared with heparin plus Gp IIb/IIIa at 4.1% (p<0.001).
JAMA, 2003;289:853-863
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