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Bivalirudin for patients with acute coronary syndromes
Gregg W Stone1, Brent T McLaurin, David A Cox
1Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY 10022, USA. gs2184@columbia.edu
Insights
Bivalirudin, a direct thrombin inhibitor, demonstrated comparable efficacy to heparin in acute coronary syndromes. Bivalirudin alone significantly reduced major bleeding events compared to heparin plus glycoprotein IIb/IIIa inhibitors.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Current guidelines advocate early invasive treatment for acute coronary syndromes (ACS) using antithrombotic therapy.
- Standard therapy includes heparin and glycoprotein IIb/IIIa inhibitors.
Purpose of the Study:
- To evaluate the efficacy and safety of bivalirudin, a direct thrombin inhibitor, in patients with moderate- to high-risk ACS undergoing invasive procedures.
- To compare bivalirudin-based regimens with standard heparin therapy.
Main Methods:
- A large-scale randomized trial involving 13,819 ACS patients.
- Three antithrombotic regimens were compared: heparin/enoxaparin + glycoprotein IIb/IIIa inhibitor, bivalirudin + glycoprotein IIb/IIIa inhibitor, and bivalirudin alone.
- Primary end points included a composite ischemia event, major bleeding, and net clinical outcome.
Main Results:
- Bivalirudin plus glycoprotein IIb/IIIa inhibitors showed noninferiority to heparin plus glycoprotein IIb/IIIa inhibitors for ischemia, bleeding, and net clinical outcome.
- Bivalirudin alone demonstrated noninferiority for ischemia but significantly reduced major bleeding (3.0% vs. 5.7%) and improved net clinical outcome compared to heparin plus glycoprotein IIb/IIIa inhibitors.
Conclusions:
- In moderate- to high-risk ACS patients undergoing invasive procedures, bivalirudin offers similar ischemic protection to heparin.
- Bivalirudin monotherapy is associated with significantly lower bleeding rates and improved net clinical outcomes.
Background:
Current guidelines for patients with moderate- or high-risk acute coronary syndromes recommend an early invasive approach with concomitant antithrombotic therapy, including aspirin, clopidogrel, unfractionated or low-molecular-weight heparin, and glycoprotein IIb/IIIa inhibitors. We evaluated the role of thrombin-specific anticoagulation with bivalirudin in such patients.
Methods:
We assigned 13,819 patients with acute coronary syndromes to one of three antithrombotic regimens: unfractionated heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor, bivalirudin plus a glycoprotein IIb/IIIa inhibitor, or bivalirudin alone. The primary end points were a composite ischemia end point (death, myocardial infarction, or unplanned revascularization for ischemia), major bleeding, and the net clinical outcome, defined as the combination of composite ischemia or major bleeding.
Results:
Bivalirudin plus a glycoprotein IIb/IIIa inhibitor, as compared with heparin plus a glycoprotein IIb/IIIa inhibitor, was associated with noninferior 30-day rates of the composite ischemia end point (7.7% and 7.3%, respectively), major bleeding (5.3% and 5.7%), and the net clinical outcome end point (11.8% and 11.7%). Bivalirudin alone, as compared with heparin plus a glycoprotein IIb/IIIa inhibitor, was associated with a noninferior rate of the composite ischemia end point (7.8% and 7.3%, respectively; P=0.32; relative risk, 1.08; 95% confidence interval [CI], 0.93 to 1.24) and significantly reduced rates of major bleeding (3.0% vs. 5.7%; P<0.001; relative risk, 0.53; 95% CI, 0.43 to 0.65) and the net clinical outcome end point (10.1% vs. 11.7%; P=0.02; relative risk, 0.86; 95% CI, 0.77 to 0.97).
Conclusions:
In patients with moderate- or high-risk acute coronary syndromes who were undergoing invasive treatment with glycoprotein IIb/IIIa inhibitors, bivalirudin was associated with rates of ischemia and bleeding that were similar to those with heparin. Bivalirudin alone was associated with similar rates of ischemia and significantly lower rates of bleeding. (ClinicalTrials.gov number, NCT00093158 [ClinicalTrials.gov].).
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