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 lab-made peptide of 20 amino acids. It copies hirudin, the anticoagulant in the saliva of the medicinal leech. Its two ends bind two different sites on thrombin. Thrombin is the enzyme that turns fibrinogen into the fibrin mesh of a clot. Biogen and The Medicines Company developed the drug. They sold it as Angiomax. 12
Doctors give it into a vein during heart procedures. First comes a bolus, then a drip. Unlike heparin, it does not need the cofactor antithrombin. It also 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. It also has a separate exosite that picks out its targets. Bivalirudin's N-terminal segment plugs the active site. Its C-terminal segment binds the exosite. Together they block both sites. The drug stops thrombin whether the enzyme is free in the blood or already bound in a clot. Heparin cannot do that. Thrombin slowly cuts bivalirudin itself, so the block is reversible. The half-life is about 22 minutes in people with normal kidneys. 12
What human research shows
HORIZONS-AMI was published in the New England Journal of Medicine in 2008. It randomized 3,602 patients with ST-elevation myocardial infarction. All were having primary angioplasty. They got bivalirudin alone, or heparin plus a glycoprotein IIb/IIIa inhibitor. At 30 days, net adverse clinical events occurred in 9.2% of the bivalirudin group. These were major bleeding or major cardiovascular events. In the heparin group the figure was 12.1%. Less major bleeding drove the gap (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. In heparin patients it was 0.3%. Later trials used other regimens. One example is heparin alone with modern antiplatelet pills. They found a smaller bleeding advantage, or none. So guidelines now present bivalirudin as one option. It is no longer 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 blood thinner. In HORIZONS-AMI, bivalirudin caused less of it than the heparin regimen. Other reported effects are back pain, nausea, headache and low blood pressure. The kidneys clear part of the drug. So doctors lower the infusion rate in kidney impairment. In those patients the blood-thinning effect lasts longer. 13
There is no antidote. The short half-life is the safeguard. Trials showed one specific hazard. That hazard is acute stent thrombosis in the hours after a procedure, before oral antiplatelet drugs take full effect. 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 won approval in 2000. It is a blood thinner for patients having a coronary stent or balloon procedure. That includes patients who had a bad reaction to heparin. Generic versions are available. 14
How does bivalirudin differ from heparin?
Heparin works indirectly by activating antithrombin. It cannot reach thrombin already trapped in a clot. Bivalirudin binds thrombin directly at two sites. That includes clot-bound thrombin. Its dose response is more predictable. It does not cause heparin-induced thrombocytopenia. 12
Is it related to leech anticoagulant?
Yes. Hirudin, the natural thrombin blocker in medicinal leech saliva, was the model. Bivalirudin is a shorter lab-made peptide. Thrombin can slowly break it down. So its action is short and reversible. 2
What happened in HORIZONS-AMI?
3,602 heart attack patients had emergency stenting. Bivalirudin caused less major bleeding than heparin plus a platelet blocker. It also led to fewer cardiac deaths at 30 days. But it caused 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