What is the recommended dosing regimen for Bivalirudin (anticoagulant) in patients undergoing percutaneous coronary intervention (PCI)?

Bivalirudin Dosing Regimen for PCI

The recommended dosing regimen for bivalirudin in patients undergoing percutaneous coronary intervention (PCI) is an intravenous bolus dose of 0.75 mg/kg, followed immediately by a maintenance infusion of 1.75 mg/kg/hour for the duration of the procedure, with consideration for extending the infusion post-procedure for up to 4 hours in STEMI patients. 1, 2

Standard Dosing Protocol

• Administer an initial IV bolus of 0.75 mg/kg 1
• Follow immediately with a maintenance infusion of 1.75 mg/kg/hour for the duration of the PCI procedure 1, 2
• Five minutes after the bolus dose, assess activated clotting time (ACT) to determine if an additional bolus of 0.3 mg/kg is needed 1
• For patients with ST-segment elevation MI (STEMI), consider extending the infusion at 1.75 mg/kg/hour for up to 4 hours post-procedure 1, 3
• After cessation of the 1.75 mg/kg/hour infusion, a reduced infusion dose of 0.25 mg/kg/hour may be continued for 4-12 hours as clinically necessary in STEMI patients 3, 2

Dose Adjustments for Special Populations

• For patients with creatinine clearance less than 30 mL/min, maintain the standard bolus dose but reduce the infusion rate to 1 mg/kg/hour 1, 2
• For patients on hemodialysis, maintain the standard bolus dose but reduce the infusion rate to 0.25 mg/kg/hour 1
• If the patient has previously received unfractionated heparin, wait 30 minutes before administering the bivalirudin bolus to avoid anticoagulant "stacking" 2

Clinical Evidence Supporting This Regimen

• Bivalirudin with a full-dose post-PCI infusion (1.75 mg/kg/hour) for 2-4 hours has been shown to be superior to unfractionated heparin (UFH) in reducing the 30-day composite of all-cause death or BARC types 3-5 bleeding (3.06% versus 4.39%, p=0.007) 3
• All-cause death was also reduced with bivalirudin compared to UFH (2.96% versus 3.92%, p=0.04) 3
• The risk of 30-day stent thrombosis was lower with bivalirudin plus post-PCI infusion compared to UFH (0.37% versus 1.1%, p=0.0015) 3
• Without a post-PCI infusion, bivalirudin has been associated with an increased risk of acute stent thrombosis compared to heparin with glycoprotein IIb/IIIa inhibitors (1.3% versus 0.3%, p<0.001) 3, 2

Recommendations from Clinical Guidelines

• The American College of Cardiology/American Heart Association guidelines recommend bivalirudin as a Class I recommendation (Level of Evidence B) for use in PCI 2
• The European Society of Cardiology guidelines list bivalirudin as a Class IIb recommendation (Level of Evidence A) as an alternative to UFH 3
• Bivalirudin is recommended over UFH with glycoprotein IIb/IIIa inhibitors in patients at high risk of bleeding (Class IIa, Level of Evidence B) 2

Important Considerations and Caveats

• Bivalirudin has a short half-life of approximately 25 minutes in patients with normal renal function, requiring careful timing of administration 4, 2
• To mitigate the risk of acute stent thrombosis, ensure adequate loading with antiplatelet agents when using bivalirudin 2
• Avoid crossover between UFH and low molecular weight heparin when using bivalirudin, as this is not recommended 3, 5
• Bivalirudin is contraindicated in patients with significant active bleeding or hypersensitivity to the drug or its components 1

By following this evidence-based dosing regimen, clinicians can optimize the anticoagulant effect of bivalirudin while minimizing bleeding complications in patients undergoing PCI.