- Question
- Is anticoagulation with bivalirudin alone superior to heparin plus a glycoprotein IIb/IIIa inhibitor in patients with ST-segment elevation myocardial infarction undergoing primary PCI?
- Design
- Randomized trial with single-blind masking per the registry, enrolling 3602 patients with ST-segment elevation myocardial infarction presenting within 12 hours of symptom onset. It used a factorial design, with a pharmacology arm (reported in this publication) and a stent arm.
- Population
- Patients with acute ST-segment elevation myocardial infarction presenting within 12 hours of symptom onset and undergoing primary PCI.
- Intervention
- Bivalirudin alone as the anticoagulant during primary PCI, with glycoprotein IIb/IIIa inhibitors reserved for bail-out use.
- Control
- Heparin plus routine use of a glycoprotein IIb/IIIa inhibitor.
- Primary outcome
- Two primary end points at 30 days: major bleeding and net adverse clinical events (major bleeding or major adverse cardiovascular events: death, reinfarction, ischemic target-vessel revascularization and stroke).
- Results
- Net adverse clinical events at 30 days were lower with bivalirudin (9.2% vs. 12.1%; relative risk 0.76; 95% CI 0.63 to 0.92; P=0.005), driven by less major bleeding (4.9% vs. 8.3%; RR 0.60; 95% CI 0.46 to 0.77; P<0.001). Cardiac death was lower with bivalirudin (1.8% vs. 2.9%; RR 0.62; 95% CI 0.40 to 0.95; P=0.03).
- Safety
- Bivalirudin was associated with a higher risk of acute stent thrombosis within 24 hours, with no significant difference by 30 days.
- Conclusion
- In ST-segment elevation myocardial infarction treated with primary PCI, bivalirudin alone reduced major bleeding and 30-day net adverse clinical events compared with heparin plus a glycoprotein IIb/IIIa inhibitor.
- Why it matters
- It established bivalirudin as an anticoagulant option with lower bleeding risk and better early outcomes in primary PCI, and prompted reconsideration of routine glycoprotein IIb/IIIa inhibitor use.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 10, 2026