Bivalirudin With a High-Dose Post-PCI Infusion Versus Heparin During Primary PCI in STEMI: One-Year Results From the BRIGHT-4 Trial

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.