Bivalirudin With a High-Dose Post-PCI Infusion Versus Heparin During Primary Percutaneous Coronary Intervention (PCI) in STEMI: One-Year Results From the BRIGHT-4 Trial
Primary result · Composite of all-cause death or Bleeding Academic Research Consortium types 3 to 5 bleedingResult — go to the resultHazard ratio 0.73 95% CI 0.58–0.92Authors' conclusion
Among patients with ST-segment-elevation myocardial infarction undergoing primary PCI with radial artery access, the benefits of bivalirudin with a high-dose post-PCI infusion in reducing the composite end point of all-cause death or Bleeding Academic Research Consortium types 3 to 5 bleeding at 30 days compared with heparin monotherapy are maintained through 12-month follow-up. These findings support the use of bivalirudin with a post-PCI high-dose infusion as an alternative to heparin to reduce mortality and major bleeding in patients with ST-segment-elevation myocardial infarction.
Study context
- Population
- Patients with ST-segment-elevation myocardial infarction undergoing primary PCI with radial artery accessrandomly assigned
- Participants
- 6,016 patients
- Comparison
- Bivalirudin with a high-dose post-PCI infusion vs heparin monotherapy
- Bivalirudin groupn = 3,009
- Heparin groupn = 3,007reference
- Primary endpoint
- Composite of:
- All-cause death
- Bleeding Academic Research Consortium types 3 to 5 bleeding
- Follow-up
- 12 months
Methodological details1:1 randomization, radial artery access, 12-month follow-up
- 1:1 randomization
- Radial artery access
- 12-month follow-up
Primary result
As reported in the abstract
Hazard ratio
0.73
95% CI 0.58–0.92
P = 0.007
Events by treatment group
Further findings
| Outcome | Bivalirudin group | Heparin group | Hazard ratio (95% CI) | P value | |
|---|---|---|---|---|---|
| Stent thrombosis · 12 months | 0.8% | 1.3% | 0.60 (0.36–0.99) | P = 0.045 | |
| All-cause death · 12 months | 3.8% | 4.8% | 0.80 (0.63–1.02) | P = 0.08 | |
| 0.20.5125Hazard ratio (log scale) |
Cardiovascular death, reinfarction, ischemia-driven target vessel revascularization, and stroke · 12 months
- Nonsignificant differences between the 2 groups
Safety
| Outcome | Bivalirudin group | Heparin group | Hazard ratio (95% CI) | P value | |
|---|---|---|---|---|---|
| Bleeding Academic Research Consortium types 3 to 5 bleeding · 12 months | 0.6% | 1.2% | 0.49 (0.28–0.87) | P = 0.01 | |
| 0.20.5125Hazard ratio (log scale) |
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →