Bivalirudin With a High-Dose Post-PCI Infusion Versus Heparin During Primary PCI in STEMI: One-Year Results From the BRIGHT-4 Trial
In brief
Bivalirudin lowers death or major bleeding by 27% at one year after STEMI PCI
Among 6,016 patients undergoing primary PCI through radial access, 4.1% given bivalirudin with a high-dose infusion had died or experienced major bleeding by 12 months, compared with 5.6% given heparin. Major bleeding and stent thrombosis were also less frequent, while the difference in death alone was not statistically significant; the findings apply to this specific PCI setting.
- Journal
- Circulation. Cardiovascular interventions (Q1)
- Published
- 31 October 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Zhenyang Liang, Lei Qin, Mian Wang, Xianzhao Wang, Huanyi Zhang, Yin Liu, et al.
- PMID
- 42965935
- DOI
- 10.1161/CIRCINTERVENTIONS.126.017029
Why clinicians should know about it
- Picked for Cardiology and Cardiovascular Medicine (top studies of the week, 8 November 2026): Large randomized trial follow-up informs anticoagulation during primary PCI
Abstract
BACKGROUND: The BRIGHT-4 trial (Bivalirudin With Prolonged Full-Dose Infusion During Primary PCI Versus Heparin Trial-4) demonstrated that procedural anticoagulation with bivalirudin plus a high-dose postprocedure infusion reduced the 30-day composite end point of all-cause death or Bleeding Academic Research Consortium types 3 to 5 bleeding compared with heparin monotherapy in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI) with radial artery access. We now report the 12-month follow-up results to evaluate the long-term outcomes of primary PCI with these 2 anticoagulation regimens. METHODS: In this multicenter, open-label, randomized controlled trial, 6016 patients with ST-segment-elevation myocardial infarction undergoing primary PCI with radial artery access were randomly assigned (1:1) to receive bivalirudin with a high-dose post-PCI infusion for 2 to 4 hours (n=3009) or heparin monotherapy (n=3007). The primary outcome of interest was the composite of all-cause death or Bleeding Academic Research Consortium types 3 to 5 bleeding at 12 months. RESULTS: At 12 months, the primary outcome occurred in 124 (4.1%) patients in the bivalirudin group and 169 (5.6%) patients in the heparin group (hazard ratio, 0.73 [95% CI, 0.58-0.92]; P=0.007). Bivalirudin resulted in lower 12-month rates of Bleeding Academic Research Consortium types 3 to 5 bleeding (0.6% versus 1.2%; hazard ratio, 0.49 [95% CI, 0.28-0.87]; P=0.01) and stent thrombosis (0.8% versus 1.3%; hazard ratio, 0.60 [95% CI, 0.36-0.99]; P=0.045), with nonsignificant differences in all-cause death (3.8% versus 4.8%; hazard ratio, 0.80 [95% CI, 0.63-1.02]; P=0.08), cardiovascular death, reinfarction, ischemia-driven target vessel revascularization, and stroke between the 2 groups. CONCLUSIONS: 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. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03822975.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.