Bivalirudin
Direct thrombin inhibitor
Also Angiomax, Angiox, Hirulog, Bivalirudin trifluoroacetate
- Evidence
- AStrong human evidence
- FDA status
- FDA approvedas of 2026-10-26
- Route
- Intravenous
- Studies cited
- 1 human0 animal or cell
It is a hospital drug that stops blood clots during heart procedures such as stenting. A trial of 3,602 heart attack patients found less bleeding than with heparin, but more clots in the stent early on.
Sold for
Bivalirudin is a hospital anticoagulant, and the argument around it has been whether it beats heparin during stenting by causing less bleeding without more clots.
Studies say
In a 3,602-patient randomized trial of heart attack patients undergoing stenting, bivalirudin reduced major bleeding and 30-day cardiac death compared with heparin plus a platelet blocker, at the cost of more stent thrombosis in the first 24 hours (grade A).
Why grade A. Approval and guideline use rest on several randomized trials in coronary intervention; the largest cited here is HORIZONS-AMI, which randomized 3,602 heart attack patients and found less major bleeding and lower cardiac mortality than heparin plus a glycoprotein IIb/IIIa inhibitor. Multiple large randomized trials with clinical endpoints is grade A. 3
FDA. Bivalirudin is FDA-approved and sold as Angiomax and generics, given intravenously as an anticoagulant during percutaneous coronary intervention (angioplasty and stenting), including in patients with heparin-induced thrombocytopenia. It was first approved in December 2000. 14
Written from 4 cited sources. Fact-checked 2026-10-27: 14 claims checked, 2 corrected, 1 sources unreachable. Last refreshed 2026-10-27. Not physician reviewed.
What this means for you
- What people take it for
- Preventing clots during stenting and angioplasty
- Can a US doctor prescribe it?
- Yes, FDA approved for use during stenting and angioplasty.
- Properly tested in people?
- Yes, in large controlled trials. The main trial had 3,602 people.
Evidence checklist
- Randomised controlled trial HORIZONS-AMI randomised trialyes
- Human study over 100 people HORIZONS-AMI, 3,602 patientsyes
- More than one research group Several trials across centres; approved since 2000yes
- Clinical outcomes, not surrogate markers Major bleeding and cardiac death endpointsyes
- Human safety data beyond case reports Bleeding data; more early stent thrombosisyes
Drawn from the cited studies below. A dash means the sources give no information.
What it is
Bivalirudin is a synthetic 20-amino-acid peptide modelled on hirudin, the anticoagulant in the saliva of the medicinal leech. Its two ends bind two different sites on thrombin, the enzyme that converts fibrinogen into the fibrin mesh of a clot. It was developed by Biogen and The Medicines Company and sold as Angiomax. 12
It is given as an intravenous bolus followed by infusion during coronary procedures. Unlike heparin, it does not need the cofactor antithrombin and does not cause heparin-induced thrombocytopenia, so it is an option for patients who have had that reaction. 1
How it works
Thrombin has an active site, where it cuts fibrinogen, and a separate exosite that recognises substrates. Bivalirudin's N-terminal segment plugs the active site and its C-terminal segment binds the exosite, blocking both. It inhibits thrombin whether the enzyme is free in the blood or already bound in a clot, which heparin cannot do. Thrombin slowly cleaves bivalirudin itself, so the block is reversible and the drug has a half-life of about 22 minutes in people with normal kidneys. 12
What human research shows
HORIZONS-AMI, published in the New England Journal of Medicine in 2008, randomized 3,602 patients with ST-elevation myocardial infarction undergoing primary angioplasty to bivalirudin alone or to heparin plus a glycoprotein IIb/IIIa inhibitor. At 30 days, net adverse clinical events (major bleeding or major cardiovascular events) occurred in 9.2% of the bivalirudin group versus 12.1% of the heparin group, driven by less major bleeding (4.9% versus 8.3%). Cardiac death at 30 days was lower with bivalirudin (1.8% versus 2.9%). 3
The trade-off was acute stent thrombosis: clots formed in the new stent within 24 hours in 1.3% of bivalirudin patients versus 0.3% of heparin patients. Later trials with different comparators (heparin alone, with modern oral antiplatelet drugs) found smaller or no bleeding advantage, which is why guidelines now present bivalirudin as one option and no longer as the default. 3
| Study | Model | Finding |
|---|---|---|
| HORIZONS-AMI, NEJM 2008 | Humans, n=3,602 with ST-elevation heart attack undergoing primary angioplasty, randomized open-label | Net adverse clinical events 9.2% versus 12.1%, major bleeding 4.9% versus 8.3%, 30-day cardiac death 1.8% versus 2.9%; acute stent thrombosis 1.3% versus 0.3%. 3 |
| Pharmacology review, Drugs 2005 | Review of mechanism and clinical trials | Bivalirudin reversibly inhibits both free and clot-bound thrombin and provides predictable anticoagulation without antithrombin or platelet factor 4 interaction. 2 |
Safety
Bleeding is the main risk of any anticoagulant, and in HORIZONS-AMI bivalirudin caused less of it than the heparin regimen. Other reported effects are back pain, nausea, headache and low blood pressure. Because the drug is cleared partly by the kidneys, the infusion rate is reduced in renal impairment and the anticoagulant effect lasts longer in those patients. 13
There is no antidote; the drug's short half-life is the safeguard. Acute stent thrombosis in the hours after a procedure, before oral antiplatelet drugs take full effect, is the specific hazard shown in trials. 3
Questions for your clinician
- Why was this anticoagulant chosen over heparin for my procedure?
- How does kidney function change the way it is given?
- What is the risk of clot formation in the first hours afterward?
Questions people ask
Is bivalirudin FDA-approved?
Yes. Angiomax was approved in 2000 as an anticoagulant for patients undergoing percutaneous coronary intervention, including those with heparin-induced thrombocytopenia. Generic versions are available. 14
How does bivalirudin differ from heparin?
Heparin works indirectly by activating antithrombin and cannot reach thrombin already trapped in a clot. Bivalirudin binds thrombin directly at two sites, including clot-bound thrombin, has a more predictable dose response and does not cause heparin-induced thrombocytopenia. 12
Is it related to leech anticoagulant?
Yes. It was designed from hirudin, the natural thrombin inhibitor in medicinal leech saliva, but is a shorter synthetic peptide that thrombin can slowly degrade, giving it a short, reversible action. 2
What happened in HORIZONS-AMI?
Among 3,602 heart attack patients having emergency stenting, bivalirudin caused less major bleeding and fewer cardiac deaths at 30 days than heparin plus a platelet blocker, but more stent clots in the first 24 hours. 3
Citations
- Drugs.com monograph: bivalirudin drugs.com
- Moen 2005, Drugs: bivalirudin, a review of its use in patients undergoing percutaneous coronary intervention link.springer.com
- Stone 2008, NEJM: bivalirudin during primary PCI in acute myocardial infarction (HORIZONS-AMI) doi.org
- FDA Drugs@FDA: Angiomax (bivalirudin) NDA 020873 accessdata.fda.gov