Does Bivalirudin work?
Yes, in large controlled trials. The main trial had 3,602 people.
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
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
Evidence checklist
- Randomised controlled trial HORIZONS-AMI randomised trial
- Human study over 100 people HORIZONS-AMI, 3,602 patients
- More than one research group Several trials across centres; approved since 2000
- Clinical outcomes, not surrogate markers Major bleeding and cardiac death endpoints
- Human safety data beyond case reports Bleeding data; more early stent thrombosis
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More on Bivalirudin
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
Reference information only, not medical advice. Drawn from the Bivalirudin article, fact-checked against the cited sources. No dosing anywhere on this site.