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Published on: June 12, 2021
Bivalirudin during primary PCI in acute myocardial infarction
Gregg W Stone1, Bernhard Witzenbichler, Giulio Guagliumi
1Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY 10022, USA. gs2184@columbia.edu
Insights
Bivalirudin monotherapy in ST-segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention significantly reduced net adverse clinical events and major bleeding compared to heparin with glycoprotein IIb/IIIa inhibitors. This approach also lowered 30-day cardiac and all-cause mortality.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Bivalirudin, a direct thrombin inhibitor, shows promise in reducing bleeding complications during percutaneous coronary intervention (PCI) compared to heparin plus glycoprotein IIb/IIIa inhibitors.
- However, its safety and efficacy in high-risk patients, particularly those with ST-segment elevation myocardial infarction (STEMI), remain under investigation.
Purpose of the Study:
- To evaluate the efficacy and safety of bivalirudin monotherapy versus heparin plus glycoprotein IIb/IIIa inhibitors in patients with STEMI undergoing primary PCI.
- To compare rates of major bleeding and net adverse clinical events (NACE) within 30 days between the two treatment groups.
Main Methods:
- A randomized trial involving 3602 patients with STEMI presenting within 12 hours of symptom onset.
- Patients undergoing primary PCI were assigned to receive either bivalirudin alone or heparin plus a glycoprotein IIb/IIIa inhibitor.
- Primary endpoints were major bleeding and NACE, defined as a composite of major bleeding or major adverse cardiovascular events.
Main Results:
- Bivalirudin monotherapy resulted in a significantly lower 30-day rate of NACE (9.2% vs. 12.1%) and major bleeding (4.9% vs. 8.3%) compared to the heparin group.
- While acute stent thrombosis risk was transiently increased within 24 hours with bivalirudin, it was not significant by 30 days.
- Bivalirudin also led to significantly lower 30-day rates of death from cardiac causes (1.8% vs. 2.9%) and all causes (2.1% vs. 3.1%).
Conclusions:
- In STEMI patients undergoing primary PCI, bivalirudin monotherapy is superior to heparin plus glycoprotein IIb/IIIa inhibitors in reducing 30-day major bleeding and net adverse clinical events.
- Bivalirudin monotherapy offers a favorable risk-benefit profile, including reduced mortality, for this patient population.
Background:
Treatment with the direct thrombin inhibitor bivalirudin, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, results in similar suppression of ischemia while reducing hemorrhagic complications in patients with stable angina and non-ST-segment elevation acute coronary syndromes who are undergoing percutaneous coronary intervention (PCI). The safety and efficacy of bivalirudin in high-risk patients are unknown.
Methods:
We randomly assigned 3602 patients with ST-segment elevation myocardial infarction who presented within 12 hours after the onset of symptoms and who were undergoing primary PCI to treatment with heparin plus a glycoprotein IIb/IIIa inhibitor or to treatment with bivalirudin alone. The two primary end points of the study were major bleeding and combined adverse clinical events, defined as the combination of major bleeding or major adverse cardiovascular events, including death, reinfarction, target-vessel revascularization for ischemia, and stroke (hereinafter referred to as net adverse clinical events) within 30 days.
Results:
Anticoagulation with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, resulted in a reduced 30-day rate of net adverse clinical events (9.2% vs. 12.1%; relative risk, 0.76; 95% confidence interval [CI] 0.63 to 0.92; P=0.005), owing to a lower rate of major bleeding (4.9% vs. 8.3%; relative risk, 0.60; 95% CI, 0.46 to 0.77; P<0.001). There was an increased risk of acute stent thrombosis within 24 hours in the bivalirudin group, but no significant increase was present by 30 days. Treatment with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, resulted in significantly lower 30-day rates of death from cardiac causes (1.8% vs. 2.9%; relative risk, 0.62; 95% CI, 0.40 to 0.95; P=0.03) and death from all causes (2.1% vs. 3.1%; relative risk, 0.66; 95% CI, 0.44 to 1.00; P=0.047).
Conclusions:
In patients with ST-segment elevation myocardial infarction who are undergoing primary PCI, anticoagulation with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, results in significantly reduced 30-day rates of major bleeding and net adverse clinical events. (ClinicalTrials.gov number, NCT00433966 [ClinicalTrials.gov].).
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