Bivalirudin With a High-Dose Post-PCI Infusion Versus Heparin During Primary PCI in STEMI: One-Year Results From the BRIGHT-4 Trial
Zhenyang Liang, Lei Qin, Mian Wang, Xianzhao Wang, Huanyi Zhang, Yin Liu, Yan Li, Limin Liu, Jun Luo, Songwu Dong, Jincheng Guo, Hengqing Zhu, Shengli Li, Haijun Zheng, Lijun Liu, Yanqing Wu, Yiming Zhong, Miaohan Qiu, Yi Li, Yaling Han, Gregg W. StoneBACKGROUND:
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];
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.
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