Safety and efficacy of bivalirudin with glycoprotein IIb/IIIa for high-risk percutaneous coronary intervention.

AIMS: The aim of the study was to assess the safety and efficacy of bivalirudin + glycoprotein (Gp) IIb/IIIa inhibitor as compared to unfractionated heparin (UFH) + Gp IIb/IIIa inhibitor in high risk patients undergoing elective percutaneous coronary intervention (PCI). The primary end point was time to sheath removal and ambulation where as peri-procedure myocardial damage, access site bleeding and major adverse cardiac events (MACE) rates were secondary end points.

METHODS: One hundred and one high risk patients undergoing elective PCI were randomly assigned to either bivalirudin + GpIIb/IIIa inhibitor or UFH + Gp IIb/IIIa inhibitor. PCI was performed by standard technique and activated clotting time was monitored immediately on arrival to recovery area and every 60 min thereafter. Sheath were pulled out once ACT was below 150 seconds and patients were mobilized 6hrs after sheath were removed. Peri-procedure myocardial damage was assessed by serial Trop I levels.

RESULTS: Patient assigned to bivalirudin + tirofiban has significantly reduced time to sheath removal and ambulation as compared to those who received UFH + tirofiban (p < 0.0001) although peak Act did not differ in the groups. Peak Trop I levels were significantly lower in bivalirudin + tirofiban group (p = 0.023) and peri-procedure Trop I elevation occurred in significantly lower number of patients treated with bivalirudin + tirofiban (p = 0.029).

CONCLUSIONS: The combination of bivalirudin + tirofiban was safe and effective as compared to UFH + tirofiban in high risk patients undergoing elective PCI.