October 31, 2026Circulation Cardiovascular Interventions
Bivalirudin With a High-Dose Post-PCI Infusion Versus Heparin During Primary PCI in STEMI: One-Year Results From the BRIGHT-4 Trial
Key result
Post-PCI bivalirudin infusion cuts 12-month death or major bleeding ~27% vs heparin monotherapy.
- HR 0.73
- 95% CI 0.58-0.92
- P=0.007
- n=6,016
Why the study?
The BRIGHT-4 trial demonstrated that bivalirudin plus a high-dose postprocedure infusion reduced 30-day all-cause death or major bleeding compared with heparin monotherapy during primary PCI for STEMI, prompting evaluation of 12-month outcomes with these 2 anticoagulation regimens.
Does bivalirudin with a high-dose post-PCI infusion reduce the composite of all-cause death or BARC types 3 to 5 bleeding at 12 months compared with heparin monotherapy in patients with STEMI undergoing primary PCI with radial artery access?
Study Design
Type
RCT (n=6,016)
Blinding
Open-label
Randomization
1:1
Multicenter
Yes
Structured PICO
Does bivalirudin with a high-dose post-PCI infusion reduce the composite of all-cause death or BARC types 3 to 5 bleeding at 12 months compared with heparin monotherapy in patients with STEMI undergoing primary PCI with radial artery access?
P
Population
6,016 patients with ST-segment–elevation myocardial infarction undergoing primary PCI with radial artery access, followed for 12 months.
I
Intervention
Bivalirudin with a high-dose post-PCI infusion for 2 to 4 hours (n=3009)
C
Comparator
Heparin monotherapy (n=3007)
O
Outcome
Composite of all-cause death or Bleeding Academic Research Consortium (BARC) types 3 to 5 bleeding at 12 monthscomposite
Main Result
Hazard Ratio: 0.73 (95% CI 0.58–0.92)
Absolute Event Rate: 4.1% vs 5.6%
p-value: p=0.007
In patients with STEMI undergoing primary PCI via radial access, bivalirudin with a 2-to-4-hour high-dose post-PCI infusion maintained a significant reduction in the composite of all-cause death or major bleeding, as well as stent thrombosis, through 12 months compared with heparin monotherapy.
Limitations
- open-label design
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Compared with heparin, bivalirudin plus a short infusion substantially improved the likelihood of surviving a STEMI and reduced the two most feared complications—major bleeding and stent thrombosis.”
“It's approximately $150 more expensive than heparin, which is nothing in the price of a STEMI, and to save lives and prevent all the major bleeds. If we did a cost-effectiveness analysis, it would be economically dominant. It would cost less.”
“Prior studies mixed patients with NSTEMI with STEMI, bivalirudin with no infusion or with a low-dose or high-dose infusion, heparin with or without routine glycoprotein IIb/IIIa inhibitor use, radial versus femoral access, and previous use of anticoagulants in both arms before randomization. Therefore, these trials were unable to sort out the relative risks and benefits of the two regimens that have emerged as the safest and most effective in patients undergoing primary PCI in STEMI with radial access.”
Implication
Supports bivalirudin with prolonged infusion over heparin in STEMI primary PCI; extends prior bivalirudin trial evidence.
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.
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Cite This Study
梁振洋 et al. (2026) conducted an RCT in ST-segment–elevation myocardial infarction (STEMI) (n=6,016). Bivalirudin with a high-dose post-PCI infusion vs. Heparin monotherapy was evaluated on Composite of all-cause death or Bleeding Academic Research Consortium (BARC) types 3 to 5 bleeding at 12 months (HR 0.73, 95% CI 0.58-0.92, p=0.007). Bivalirudin with a high-dose post-PCI infusion reduced 12-month all-cause death or BARC 3-5 bleeding vs heparin monotherapy (4.1% vs 5.6%; HR 0.73; 95% CI 0.58-0.92; P=0.007).