Abstract 5957: Randomized Comparison of Bivalirudin Versus Tirofiban Plus Unfractionated Heparin Administration in Diabetic Patients Undergoing Elective Coronary Stenting
Bivalirudin has demonstrated a similar efficacy but less rate of bleedings compared with heparin plus routine glycoprotein IIb/IIIa inhibitors (GPI) in patients undergoing elective and urgent percutaneous coronary intervention (PCI). In diabetic patients undergoing PCI administration of GPI is suggested in urgent and elective procedures. The present trial investigated short-term outcome and bleeding events in diabetic patients undergoing elective PCI randomized to 2 antithrombotic strategies: bivalirudin versus unfractionated heparin (UFH) and routine tirofiban administration. 335 consecutive patients with diabetes, referred to our institution for elective coronary procedures, were randomly assigned to receive intravenous bivalirudin (0.75mg/Kg bolus plus 1.75mg/Kg per hour for the duration of PCI) or UFH (bolus of 70 IU/kg associated with additional doses if activated clotting time <300 seconds) plus routine tirofiban (bolus dose of 12 μg per kilogram of body weight, followed by an infusion of 0.15 μg per kilogram per minute for 12 hours). Both groups received daily aspirin long-life (100 mg/day) and clopidogrel (75 mg/day) for at least 30 days after PCI in case of bare metal stent or at least 6 months with a drug-eluting stent implantation. The primary end point was the 30-day composite incidence of death, myocardial infarction, urgent repeat revascularization and in-hospital bleeding. Thirty-day outcome is reported in the table⇓. The primary composite end point was significantly lower in patients in the bivalirudin group compared with patients in the UFH plus tirofiban group, due to the lower rate of bleeding complications. In diabetic patients undergoing elective PCI the antithrombotic strategy of bivalirudin compared with UFH plus routine tirofiban is safe and feasible, and is associated with a significant reduction of in-hospital bleedings.