Bivalirudin Dosing in Severe Renal Impairment (CrCl 28 mL/min)
For a patient with creatinine clearance of 28 mL/min undergoing PCI, administer bivalirudin as a 0.75 mg/kg IV bolus followed by a reduced maintenance infusion of 1 mg/kg/hour (not the standard 1.75 mg/kg/hour). 1
Dosing Algorithm by Renal Function
Bolus Dose
- No reduction needed regardless of renal impairment severity 1
- Administer 0.75 mg/kg IV bolus 2, 1
- Assess ACT at 5 minutes; give additional 0.3 mg/kg bolus if needed 1
Maintenance Infusion Adjustment
The FDA-approved dosing for renal impairment is stratified as follows:
- CrCl ≥30 mL/min: Standard 1.75 mg/kg/hour 2, 1
- CrCl <30 mL/min (your patient at 28 mL/min): Reduce to 1 mg/kg/hour 2, 1
- Hemodialysis-dependent: Further reduce to 0.25 mg/kg/hour 2, 1
Pharmacokinetic Rationale
Bivalirudin clearance decreases by approximately 20-24% in patients with moderate-to-severe renal impairment (CrCl <30 mL/min), necessitating dose reduction to prevent excessive anticoagulation. 3, 4
- Renal clearance accounts for ~20% of total bivalirudin elimination, with the remainder undergoing intracellular proteolysis 3
- Plasma clearance drops from 4.58 mL/min/kg (normal function) to 2.50 mL/min/kg (moderate impairment, CrCl 30-59) and 1.46 mL/min/kg (severe impairment, CrCl <30) 4
- Despite reduced clearance, the pharmacodynamic effect (ACT prolongation) remains predictable and dose-dependent 3, 4
Monitoring Requirements
Target ACT of 350-400 seconds during PCI, with close monitoring in renal impairment due to increased bleeding risk. 4, 5
- Patients with CrCl <60 mL/min have significantly higher complication rates (18.6% vs 2.78% for normal function) 5
- aPTT should be monitored if continuing infusion post-procedure, targeting 60-80 seconds 6
- Bivalirudin's anticoagulant effect subsides approximately 1 hour after discontinuation 1
Clinical Context for Renal Impairment
Bivalirudin demonstrates superior bleeding safety compared to unfractionated heparin in renally impaired patients, making it a preferred anticoagulant choice despite the need for dose adjustment. 4, 5
- In patients with any degree of renal impairment, bivalirudin causes significantly less major bleeding than heparin (6% vs 12.7% in moderate impairment) 4
- Risk of complications increases progressively: 2.7% (CrCl >60), 14.2% (CrCl 30-60), and 37.5% (CrCl <30) 5
- Female gender and advanced age compound bleeding risk in renally impaired patients 4, 5
STEMI-Specific Consideration
- If your patient has STEMI, consider extending the 1 mg/kg/hour infusion for up to 4 hours post-procedure 1
- This extended infusion recommendation applies even with the reduced dose for renal impairment 1
Critical Pitfalls to Avoid
Do not use the standard 1.75 mg/kg/hour maintenance dose in patients with CrCl <30 mL/min—this will result in drug accumulation and excessive anticoagulation. 1, 6
- Individual dosing requirements vary widely even within the same renal function category, requiring careful aPTT/ACT titration 6
- Bivalirudin increases INR even in patients not receiving warfarin (median increase from 1.5 to 1.9), which may confound coagulation monitoring 6
- Avoid concurrent use with alteplase, amiodarone, amphotericin B, chlorpromazine, diazepam, dobutamine, prochlorperazine, reteplase, streptokinase, or vancomycin in the same IV line 1