Cardiovascular & blood

Bivalirudin

A direct thrombin inhibitor peptide used as the anticoagulant during coronary stenting, including in heparin allergy.

Strong evidenceApproved drugAdd to compare
01

What it is

Bivalirudin is a synthetic 20-amino-acid analogue of hirudin, the anticoagulant in leech saliva. It blocks thrombin directly rather than through antithrombin, which means it also works on clot-bound thrombin and does not cause the antibody problems seen with heparin. It is a hospital medicine given by infusion during percutaneous coronary intervention.

02

How it works

  1. 1

    Binds the active site and exosite I of thrombin, blocking fibrin formation.

  2. 2

    Inhibits both free and clot-bound thrombin, unlike heparin.

  3. 3

    Its effect is reversible because thrombin slowly cleaves the peptide, so clotting recovers within about an hour of stopping.

  4. 4

    Does not require antithrombin, so it works when antithrombin is low.

  5. 5

    No risk of heparin-induced thrombocytopenia or the associated antibodies.

03

What it's studied for

Anticoagulation during percutaneous coronary intervention
Patients with heparin-induced thrombocytopenia
Acute coronary syndrome managed invasively
Comparisons against heparin plus glycoprotein IIb/IIIa inhibitors
04

Reported and studied effects

  • Similar or lower rates of major bleeding than heparin plus a glycoprotein IIb/IIIa inhibitor in PCI trials
  • Comparable ischaemic outcomes at 30 days
  • Rapid loss of anticoagulant effect after stopping the infusion
  • A higher rate of stent thrombosis in one large trial when bailout glycoprotein inhibitors were withheld

Research protocol notes

Research context only

Research context only - a hospital anticoagulant. In the PCI trials the regimen was a 0.75 mg per kilogram intravenous bolus followed by an infusion of 1.75 mg per kilogram per hour for the duration of the procedure; trials measured major bleeding and major adverse cardiac events at 30 days and one year.

These figures are described so you can understand what researchers did. They are not a dose, a schedule, or a suggestion — and they are not a substitute for a doctor.

05

Possible side effects and contraindications

Safety profile

Possible side effects

  • Bleeding, including major and access-site bleeding
  • Hypotension
  • Back pain
  • Nausea
  • Rare allergic reactions
  • Stent thrombosis if anticoagulation is inadequate

Contraindications and cautions

  • Active major bleeding
  • Prior hypersensitivity
  • Severe uncontrolled hypertension
  • Not for intramuscular injection
  • Kidney impairment requires dose adjustment

A side-effect list is never complete, and these are not the only situations that warrant caution. Anything unexpected, or anything you are unsure about, should be discussed with a doctor before use.

06

Evidence assessment

Strong evidenceReplicated, large human trials
Replicated, large human trials

Several large randomised trials in PCI, including REPLACE-2, HORIZONS-AMI and VALIDATE-SWEDEHEART, with bleeding and ischaemic endpoints.

07

References

  1. 01Stone et al., Bivalirudin during primary PCI in acute myocardial infarction (HORIZONS-AMI), NEJM 2008
  2. 02European Medicines Agency - Angiox product information

References link to published literature, regulator pages or literature indexes. Where a link points to a search, it collects the peer-reviewed work on that molecule rather than a single study.