Bivalirudin

Peptide

Bivalirudin is a synthetic 20-amino acid peptide derived from hirudin (leech anticoagulant) that directly inhibits thrombin. FDA-approved 2000 for PCI anticoagulation, including patients with HIT/HITTS. A-GRADE evidence: HORIZONS-AMI showed reduced major bleeding (4.9% vs 8.3% vs heparin+GPI). Over 25,000 patients studied across REPLACE-2, ACUITY, and HORIZONS-AMI trials. B-GRADE for mortality reduction (driven by bleeding reduction). SAFETY CONCERN: Increased acute stent thrombosis within 24h (1.3% vs 0.3% in HORIZONS-AMI) - mitigated by post-PCI infusion. ESC downgraded to Class IIb in 2018. PRESCRIPTION ONLY - catheterization lab setting.

Quick Answer

What it is

Bivalirudin is a synthetic 20-amino acid peptide derived from hirudin (leech anticoagulant) that directly inhibits thrombin. FDA-approved 2000 for PCI anticoagulation, including patients with HIT/HITTS.

Key findings

  • Grade A: Major Bleeding Reduction (Percutaneous Coronary Intervention)
  • Grade A: Net Adverse Clinical Events (Percutaneous Coronary Intervention)
  • Grade B: Cardiac Protection

Safety

No specific caution or interaction language was detected in the current summary/outcome notes.

⚠️ Research Notice

This peptide information is for educational and research purposes only. Peptides may not be FDA-approved for human use and may only be legally available for research purposes. Consult qualified healthcare professionals before considering any peptide compounds.

ℹ️ Quick Facts: Bivalirudin

Quick Facts: Bivalirudin

  • Best Evidence:Grade A
  • Conditions Studied:1
  • Research Outcomes:8
  • Grade A Findings:2
  • Grade B Findings:3
  • Key Effect:Percutaneous Coronary Intervention
A2
B3
C2
D1
1 conditions · 8 outcomes

Detailed Outcomes

A
Major Bleeding Reduction
HORIZONS-AMI: Major bleeding 4.9% vs 8.3% with heparin+GPI (P<0.001). ACUITY: 47% relative reduction in major bleeding. REPLACE-2: Significantly lower bleeding with bivalirudin monotherapy. Consistent across 25,000+ patients in pooled analyses.
large↓Improves
A
Net Adverse Clinical Events
HORIZONS-AMI: NACE 9.2% vs 12.1% with heparin+GPI at 30 days. ACUITY: Similar ischemic outcomes with reduced bleeding. 1-year follow-up confirmed sustained benefit. Net clinical benefit driven primarily by bleeding reduction.
moderate↓Improves
B
Mortality
HORIZONS-AMI: 1-year all-cause mortality 3.5% vs 4.8% (P=0.037). Cardiac mortality 2.1% vs 3.1% (P=0.047). VALIDATE-SWEDEHEART: No mortality difference vs heparin alone at 180 days. Mortality benefit may relate to bleeding reduction.
moderate↓Improves
B
Acute Stent Thrombosis
SAFETY CONCERN: HORIZONS-AMI: Higher acute stent thrombosis within 24h (1.3% vs 0.3%, P<0.001). HEAT-PPCI: Stent thrombosis 3.4% vs 0.9% with heparin. Mitigated by post-PCI bivalirudin infusion (BRIGHT trial). ESC guidelines downgraded to Class IIb in 2018.
small↓Worsens
B
Cardiac Protection
7 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.
small↑Improves
C
Pulmonary Function
3 preclinical studies support this finding. Primarily preclinical evidence.
small↑Improves
C
Safety/Tolerability
3 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.
small↑Improves
D
Kidney Function
2 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.
small↑Improves

Research Citations (46)

Bivalirudin anticoagulation for cardiopulmonary bypass during cardiac surgery.
(2025)
PMID: 38084653
The efficacy and safety of bivalirudin and heparin in patients with acute coronary syndrome: a systematic review and meta-analysis.
(2025)
PMID: 39930484
Effectiveness and safety of bivalirudin anticoagulation therapy in adult patients receiving extracorporeal membrane oxygenation: A systematic review and meta-analysis.
(2025)
PMID: 40826747
Bivalirudin versus unfractionated heparin in patients with myocardial infarction undergoing percutaneous coronary intervention: A systematic review and meta-analysis of randomized controlled trials.
(2024)
PMID: 37872022
Meta-Analysis Comparing Bivalirudin Versus. Unfractionated Heparin in Adult Patients With Extracorporeal Membrane Oxygenation.
(2024)
PMID: 36449392
Bivalirudin versus heparin in contemporary percutaneous coronary interventions for patients with acute coronary syndrome: a systematic review and meta-analysis.
(2024)
PMID: 37964648
Intraoperative Bivalirudin Use in Patient Undergoing Femoral Endarterectomy with Heparin-Induced Thrombocytopenia: Case Report and Review of the Literature.
(2024)
PMID: 38016142
Heparin Versus Bivalirudin for Anticoagulation in Adult Extracorporeal Membrane Oxygenation: A Systematic Review and Meta-Analysis.
(2023)
PMID: 36355803
Bivalirudin anticoagulation in neonates and infants undergoing cardiac surgery.
(2022)
PMID: 35817672
Is bivalirudin an alternative anticoagulant for extracorporeal membrane oxygenation (ECMO) patients? A systematic review and meta-analysis.
(2022)
PMID: 35007937

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