Bivalirudin Versus Heparin in Low and Non-Low Bleeding Risk Patients Undergoing Primary Percutaneous Coronary Intervention (PCI) for STEMI: The BRIGHT-4 Trial
Authors' conclusion
Among patients with STEMI undergoing primary PCI with radial artery access, procedural anticoagulation with bivalirudin plus a high-dose post-PCI infusion for 2 to 4 hours reduced the 30-day risk of all-cause death and major bleeding in patients at low bleeding risk as well as in patients at higher-risk of bleeding.
Study context
- Population
- Patients with STEMI undergoing primary PCI with radial access; Low bleeding risk (LBR) = CRUSADE score <304,581 (76.1%) LBR
- Participants
- 6,016 patients
- Comparison
- Bivalirudin vs heparin by baseline bleeding risk
- Primary endpoint
- All-cause death or Bleeding Academic Research Consortium (BARC) types 3 to 5 bleeding
- Follow-up
- 30 days
Methodological detailsprespecified analysis
- Prespecified analysis
Primary result
As reported in the abstract
30-day all-cause death or BARC 3–5 bleeding, by bleeding risk
Bivalirudin vs HeparinDifference (95% CI)
non-LBR
−1.1%(−4.0% to 1.8%)
LBR
−1.5%(−2.3% to −0.6%)
Bivalirudin vs HeparinHazard ratio (95% CI)
non-LBR
0.88(0.62–1.26)
LBR
0.49(0.32–0.75)
Further findings
| Outcome | Non-LBR | LBR | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| 30-day primary endpoint, non-LBR vs LBR | 8.6% | 2.2% | 4.08 (3.14–5.31) | P < 0.0001 | |
| 0.20.5125Hazard ratio (log scale) |
All-cause death, by bleeding risk
- Bivalirudin reduction in all-cause death as robust in LBR as in non-LBR
- Pabsolute interaction = 0.67
- Prelative interaction = 0.06
Original publication
Bivalirudin Versus Heparin in Low and Non-Low Bleeding Risk Patients Undergoing Primary PCI for STEMI: The BRIGHT-4 Trial. J Am Coll Cardiol. Published 28 August 2026. doi:10.
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