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Peptide

Bivalirudin

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.

Research notice. This page is for education and research. Peptides may not be FDA-approved for human use and may only be legally available for research. Talk to a qualified clinician before considering any peptide.

Best evidence
Grade A
Conditions studied
1
Outcomes
8
Graded outcomes
2321

Evidence by condition

  • Strong
  • Moderate
  • Limited
  • Very limited

1 condition, plus general outcomes

Percutaneous Coronary Intervention

Percutaneous Coronary Intervention: outcomes studied for Bivalirudin
GradeOutcomeEffectSizeStudiesPeopleStudies list
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.

Improves (the measure goes down)Moderate effect79 studies

Studies that measured net adverse clinical events

and 69 more in the citations list

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.

Improves (the measure goes down)Large effect75 studies

Studies that measured major bleeding reduction

and 65 more in the citations list

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.

Worsens (the measure goes down)Small effect79 studies

Studies that measured acute stent thrombosis

and 69 more in the citations list

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.

Improves (the measure goes down)Moderate effect76 studies

Studies that measured mortality

and 66 more in the citations list

General

General: outcomes studied for Bivalirudin
GradeOutcomeEffectSizeStudiesPeopleStudies list
Cardiac Protection

7 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Small effect23 studies

Studies that measured cardiac protection

and 13 more in the citations list

Pulmonary Function

3 preclinical studies support this finding. Primarily preclinical evidence.

Improves (the measure goes up)Small effect19 studies

Studies that measured pulmonary function

and 9 more in the citations list

Safety/Tolerability

3 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Small effect19 studies

Studies that measured safety/tolerability

and 9 more in the citations list

Kidney Function

2 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Small effect18 studies

Studies that measured kidney function

and 8 more in the citations list

Key findings

  • Net Adverse Clinical EventsPercutaneous Coronary InterventionImproves (the measure goes down)
  • Major Bleeding ReductionPercutaneous Coronary InterventionImproves (the measure goes down)
  • Acute Stent ThrombosisPercutaneous Coronary InterventionWorsens (the measure goes down)

Studies cited

46 studies from PubMed

  1. Bivalirudin anticoagulation for cardiopulmonary bypass during cardiac surgery.Perfusion, 2025 · PMID 38084653
  2. The efficacy and safety of bivalirudin and heparin in patients with acute coronary syndrome: a systematic review and meta-analysis.Systematic reviews, 2025 · PMID 39930484
  3. Effectiveness and safety of bivalirudin anticoagulation therapy in adult patients receiving extracorporeal membrane oxygenation: A systematic review and meta-analysis.Medicine, 2025 · PMID 40826747
  4. Bivalirudin versus unfractionated heparin in patients with myocardial infarction undergoing percutaneous coronary intervention: A systematic review and meta-analysis of randomized controlled trials.Cardiovascular revascularization medicine : including molecular interventions, 2024 · PMID 37872022
  5. Meta-Analysis Comparing Bivalirudin Versus. Unfractionated Heparin in Adult Patients With Extracorporeal Membrane Oxygenation.Journal of pharmacy practice, 2024 · PMID 36449392
  6. Bivalirudin versus heparin in contemporary percutaneous coronary interventions for patients with acute coronary syndrome: a systematic review and meta-analysis.Cardiology journal, 2024 · PMID 37964648
  7. Intraoperative Bivalirudin Use in Patient Undergoing Femoral Endarterectomy with Heparin-Induced Thrombocytopenia: Case Report and Review of the Literature.Vascular and endovascular surgery, 2024 · PMID 38016142
  8. Heparin Versus Bivalirudin for Anticoagulation in Adult Extracorporeal Membrane Oxygenation: A Systematic Review and Meta-Analysis.ASAIO journal (American Society for Artificial Internal Organs : 1992), 2023 · PMID 36355803
  9. Bivalirudin anticoagulation in neonates and infants undergoing cardiac surgery.Journal of cardiothoracic and vascular anesthesia, 2022 · PMID 35817672
  10. Is bivalirudin an alternative anticoagulant for extracorporeal membrane oxygenation (ECMO) patients? A systematic review and meta-analysis.Thrombosis research, 2022 · PMID 35007937
  11. Bivalirudin versus heparin in adult and pediatric patients with extracorporeal membrane oxygenation therapy: A systematic review and meta-analysis.Pharmacological research, 2022 · PMID 35065202
  12. Dose estimation for bivalirudin during pediatric cardiopulmonary bypass.Paediatric anaesthesia, 2021 · PMID 33423355
  13. A Review of Bivalirudin for Pediatric and Adult Mechanical Circulatory Support.American journal of cardiovascular drugs : drugs, devices, and other interventions, 2021 · PMID 33174088
  14. Practicability of Bivalirudin plus Glycoprotein IIb/IIIa Inhibitors in Patients Undergoing Percutaneous Coronary Intervention: A Meta-Analysis.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis, 2021 · PMID 34775846
  15. The Use of Bivalirudin in Pediatric Cardiac Surgery and in the Interventional Cardiology Suite.Journal of cardiothoracic and vascular anesthesia, 2020 · PMID 32127273
  16. Bivalirudin Versus Heparin During Intervention in Acute Coronary Syndrome: A Systematic Review of Randomized Trials.Cardiovascular & hematological disorders drug targets, 2020 · PMID 31241442
  17. Meta-analysis of bivalirudin versus heparin in transradial coronary interventions.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2020 · PMID 32091668
  18. Clinical Outcomes of Bivalirudin Versus Heparin in Elderly Patients Undergoing Percutaneous Coronary Intervention: a Systematic Review and Meta-analysis of Randomized Controlled Trials.Cardiovascular drugs and therapy, 2020 · PMID 32100149
  19. Efficacy and safety of bivalirudin for percutaneous coronary intervention in acute coronary syndromes: a meta-analysis of randomized-controlled trials.Clinical research in cardiology : official journal of the German Cardiac Society, 2018 · PMID 29654437
  20. Bivalirudin versus Heparin Monotherapy in Myocardial InfarctionN Engl J Med, 2017 · PMID 28844201
  21. Bivalirudin versus Heparin plus Glycoprotein IIb/IIIa Inhibitors in Women Undergoing Percutaneous Coronary Intervention: A Meta-Analysis of Randomized Controlled Trials.PloS one, 2017 · PMID 28095453
  22. Bivalirudin versus heparin in women undergoing percutaneous coronary intervention: A systematic review and meta-analysis of randomized clinical trials.Cardiovascular revascularization medicine : including molecular interventions, 2017 · PMID 28291727
  23. Gender-based outcomes of bivalirudin versus heparin in patients undergoing percutaneous coronary interventions: Meta-analysis of randomized controlled trials.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2017 · PMID 28339139
  24. Bivalirudin versus heparin in patients undergoing percutaneous transcatheter aortic valve interventions: A systematic review and meta-analysis.Journal of interventional cardiology, 2017 · PMID 28833456
  25. Prediction of 1-year mortality and impact of bivalirudin therapy according to level of baseline risk: A patient-level pooled analysis from three randomized trialsAm Heart J, 2016 · PMID 26624854
  26. Bivalirudin as an adjunctive anticoagulant to heparin in the treatment of heparin resistance during cardiopulmonary bypass-assisted cardiac surgery.Perfusion, 2016 · PMID 25934498
  27. Bivalirudin versus unfractionated heparin for percutaneous coronary intervention with radial access: A meta-analysis of randomized trials.International journal of cardiology, 2016 · PMID 27153137
  28. Bivalirudin Versus Unfractionated Heparin in Acute Coronary Syndromes: An Updated Meta-analysis of Randomized Trials.Revista espanola de cardiologia (English ed.), 2016 · PMID 27198128
  29. Bivalirudin vs heparin with or without tirofiban during primary percutaneous coronary intervention in acute myocardial infarction: the BRIGHT randomized clinical trialJAMA, 2015 · PMID 25775052
  30. Bivalirudin versus heparin in patients with acute myocardial infarction: A meta-analysis of randomized trials.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2015 · PMID 25913723
  31. Bivalirudin versus heparin in patients treated with percutaneous coronary intervention: a meta-analysis of randomised trials.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2015 · PMID 25102830
  32. Bivalirudin Anticoagulant Therapy With or Without Platelet Glycoprotein IIb/IIIa Inhibitors During Transcatheter Coronary Interventional Procedures: A Meta-Analysis.Medicine, 2015 · PMID 26266343
  33. Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): an open-label, single centre, randomised controlled trialLancet, 2014 · PMID 25002178
  34. Bivalirudin versus heparin in patients planned for percutaneous coronary intervention: a meta-analysis of randomised controlled trials.Lancet (London, England), 2014 · PMID 25131979
  35. Bivalirudin versus heparin for percutaneous coronary intervention: an updated meta-analysis of randomized controlled trials.Cardiovascular revascularization medicine : including molecular interventions, 2014 · PMID 25440505
  36. Impact of bleeding on mortality after percutaneous coronary intervention results from a patient-level pooled analysis of the REPLACE-2, ACUITY, and HORIZONS-AMI trialsJACC Cardiovasc Interv, 2011 · PMID 21700252
  37. Bivalirudin utilization in cardiac surgery: shifting anticoagulation from indirect to direct thrombin inhibition.Canadian journal of anaesthesia = Journal canadien d'anesthesie, 2011 · PMID 21136312
  38. Bivalirudin: a review of the pharmacology and clinical application.Expert review of cardiovascular therapy, 2010 · PMID 21108549
  39. Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trialLancet, 2009 · PMID 19717185
  40. Safety and efficacy of bivalirudin with and without glycoprotein IIb/IIIa inhibitors in patients with acute coronary syndromes undergoing percutaneous coronary intervention 1-year results from the ACUITY trialCirculation, 2008 · PMID 18755342
  41. BivalirudinThromb Haemost, 2008 · PMID 18449412
  42. Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trialLancet, 2007 · PMID 17368152
  43. Bivalirudin provides increasing benefit with decreasing renal function: a meta-analysis of randomized trials.The American journal of cardiology, 2003 · PMID 14556866
  44. Bivalirudin: a review of its use in patients undergoing percutaneous coronary interventionDrugs, 2002 · PMID 16114983
  45. Bivalirudin: a review of its potential place in the management of acute coronary syndromes.Drugs, 2002 · PMID 11929334
  46. The use of bivalirudin in patients with renal impairment.The Journal of invasive cardiology, 2000 · PMID 11156732