30 Day Results

The incidence of net adverse clinical events (9.2% vs. 12.1%) and major bleeding (4.9% vs. 8.3%) was significantly reduced by bivalirudin monotherapy versus unfractionated heparin (UFH) plus a GP IIb/IIIa inhibitor with similar rates of major adverse cardiovascular events (5.4 vs. 5.5%) at 30 days. A significant reduction in the rate of cardiac mortality in patients treated with bivalirudin monotherapy versus UFH plus a GP IIb/IIIa inhibitor was observed (1.8% vs. 2.9%) at 30 days.
Pharmacokinetics
Following an IV bolus of bivalirudin of 1 mg/kg and a 4-hour 2.5 mg/kg/h IV infusion a mean steady state concentration of 12.3 ± 1.7 µg/mL is achieved
Bivalirudin is cleared from plasma by a combination of renal mechanisms and proteolytic cleavage
Half-life:-Normal renal function (≥ 90 mL/min) = 25 minutes
-Mild renal dysfunction (60–89 mL/min) = 22 minutes
-Moderate renal dysfunction (30-59 mL/min) = 34 minutes
-Severe renal dysfunction (≤ 29 mL/min) = 57 minutes
-Dialysis-dependent  = 3.5 hours

Clearance is reduced approximately 20% in patients with moderate and severe renal impairment and by 80% in dialysis-dependent patients
Bivalirudin is hemodialyzable and approximately 25% is cleared by hemodialysis.PharmacodynamicsCoagulation times return to baseline approximately 1 hour following cessation of bivalirudin administration. Dosing and administration
Bivalirudin is intended for IV use only and is supplied as a sterile, lyophilized product in single-use, glass vials. After reconstitution, each vial delivers 250 mg of bivalirudin. US dosing:
PCI Bolus: 0.75 mg/kg
PCI Infusion: 1.75 mg/kg/hEU dosing:
UA/NSTEMI-Bolus: 0.1 mg/kg
-Infusion: 0.25 mg/kg/h for up to 72 hours for medical management
-If patient proceeds to PCI, an additional bolus of 0.5 mg/kg of bivalirudin should be administered before the procedure and the infusion increased to 1.75 mg/kg/h for the duration of the procedure. PCI-Bolus: 0.75 mg/kg
-Infusion: 1.75 mg/kg/h

Coronary Artery Bypass Graft (CABG)-Patients proceeding to CABG surgery off-pump:
The IV infusion of bivalirudin should be continued until the time of surgery. Just prior to surgery, a 0.5 mg/kg bolus dose should be administered followed by a 1.75 mg/kg/h infusion for the duration of the surgery.