Circ Cardiovasc Interv. 2026 Oct 31:e017029. doi: 10.1161/CIRCINTERVENTIONS.126.017029. Online ahead of print.
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.
PMID:42965935 | DOI:10.1161/CIRCINTERVENTIONS.126.017029