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Bivalirudin vs. Heparin Anticoagulation in STEMI
Quick Takes
- Bivalirudin improves all-cause mortality and bleeding as compared to heparin in patients with STEMI undergoing primary PCI.
- In an individual patient data meta-analysis of four trials, use of a high-dose post-PCI infusion of bivalirudin was associated with fewer thrombotic complications than heparin.
- The results of this meta-analysis provide external validation of the BRIGHT-4 trial, suggesting bivalirudin should now be first-line therapy for most patients undergoing primary PCI for STEMI.
Study Questions:
What are the outcomes of bivalirudin vs. heparin anticoagulation during percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI)?
Methods:
The authors performed an individual patient data meta-analysis of large randomized trials comparing bivalirudin to heparin in patients with STEMI who were undergoing primary PCI. These included all randomized trials conducted before the BRIGHT-4 (Bivalirudin With Prolonged Full-Dose Infusion During Primary PCI Versus Heparin Trial-4) trial. The primary endpoint was all-cause mortality.
Results:
The meta-analysis included six randomized trials with 15,254 patients. Across all regimens of bivalirudin and glycoprotein IIb/IIIa inhibitor (GPI) use, bivalirudin reduced 30-day all-cause mortality (2.5% vs. 2.9%, adjusted odds ratio [aOR], 0.78; 95% confidence interval [CI], 0.62-0.99), cardiac-specific mortality (aOR, 0.69; 95% CI, 0.54-0.88), and major bleeding (aOR, 0.53; 95% CI, 0.44-0.64) as compared to heparin. Use of bivalirudin increased rates of reinfarction (aOR, 1.30; 95% CI, 1.02-1.65) and stent thrombosis (aOR, 1.43; 95% CI, 1.05-1.93) as compared to heparin therapy. In four trials of 6,244 patients who were randomized to bivalirudin at a high-dose post-PCI versus heparin without planned GPI use (the BRIGHT-4 regimens), 30-day all-cause mortality occurred in 1.8% versus 2.9% of patients (aOR, 0.74; 95% CI, 0.48-1.12) with reduced mortality (aOR, 0.68; 95% CI, 0.39-0.97) and major bleeding (aOR, 0.49; 95% CI, 0.35-0.70) but similar rates of reinfarction (aOR, 0.589; 95% CI, 0.58-1.38) and stent thrombosis (aOR, 0.80; 95% CI, 0.41-1.57).
Conclusions:
The authors conclude that use of bivalirudin with a 2- to 4-hour post-PCI high-dose infusion in patients with STEMI reduces cardiac mortality and major bleeding without an increase in ischemic events as compared to heparin monotherapy with provisional GPI use.
Perspective:
Patients undergoing primary PCI for STEMI are at increased risk of post-STEMI thromboembolic complications as well as bleeding complications from the acute medical management and PCI procedure. While several trials of bivalirudin anticoagulation have shown improved mortality and bleeding as compared to heparin when used for primary PCI, the higher rates of thromboembolic complications (e.g., reinfarction, stent thrombosis) have limited this therapy from widespread adoption. However, the recent BRIGHT-4 trial published in 2022 attempted to overcome this barrier with a higher post-PCI infusion of bivalirudin for 2-4 hours. In that trial, rates of all-cause mortality and bleeding were lower in the bivalirudin versus heparin arms without an increase in thrombotic events. This individual patient data meta-analysis of trials completed before BRIGHT-4 was reported confirm these findings. This meta-analysis provides strong supporting evidence from the BRIGHT-4 trial that bivalirudin with a higher post-PCI infusion for 2-4 hours should now be considered first-line therapy for most patients undergoing primary PCI for STEMI.
Clinical Topics: Anticoagulation Management, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Vascular Medicine, Interventions and Vascular Medicine, Chronic Angina, Anticoagulation Management and ACS
Keywords: Anticoagulants, Percutaneous Coronary Intervention, ST Elevation Myocardial Infarction
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