Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI

Summary

This study is aimed to investigate if the bivaliruding with prolonged full dose infusion after PCI is superior to heparin alone in reducing 30-day mortality or major bleeding for patients with STEMI treated with emergency PCI. A total of 6000 STEMI patients will be enrolled and randomly assigned to receive bivalirudin or heparin during emergency PCI in a 1:1 ratio. This study will provide key evidence for peri-operative anticoagulant therapy decisions in STEMI patients.

Timeline

Start

2019-02-14

Primary completion

2022-05-07

Completion

2023-05-06

Outcome

Met primary endpoint

paper Compared with heparin monotherapy, bivalirudin reduced the 30-day rate of the primary endpoint PMID 36351459 ↗

paper hazard ratio [HR] 0·69, 95% CI 0·53-0·91; p=0·0070 PMID 36351459 ↗

Publications

• Results Li Y, Liang Z, Qin L, Wang M, Wang X, Zhang H, Liu Y, Li Y, Jia Z, Liu L, Zhang H, Luo J, Dong S, Guo J, Zhu H, Li S, Zheng H, Liu L, Wu Y, Zhong Y, Qiu M, Han Y, Stone GW. Bivalirudin plus a high-dose infusion versus heparin monotherapy in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a randomised trial. Lancet. 2022 Nov 26;400(10366):1847-1857. doi: 10.1016/S0140-6736(22)01999-7. Epub 2022 Nov 6.
• Zhang D, Li Y, Qiu M, Liang Z, Xu K, Li Y, Zhang G, Xie W, Zeng H, Cheng Y, Liu J, Cheng X, Zeng Q, Zhu K, Hu J, Cheng K, Wang J, Cheng R, Zhou Y, Wang B, Cao G, Han Y, Stone GW. BMI differences on anticoagulation with bivalirudin vs. heparin during primary PCI: a BRIGHT-4 subanalysis. BMC Med. 2025 Sep 30;23(1):525. doi: 10.1186/s12916-025-04374-7.
• Su X, Qiu M, Gu C, Yang X, Liu B, Meng F, Ning B, Li W, Zhong Z, Wang Z, Shi B, Shang Z, Liang Z, Li Y, Han Y, Stone GW. Analysis of inter-hospital transfer on clinical outcomes after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: A secondary analysis of the BRIGHT-4 trial. PLoS Med. 2025 Jul 23;22(7):e1004679. doi: 10.1371/journal.pmed.1004679. eCollection 2025 Jul.
• Liao J, Qiu M, Feng X, Chen K, Zhang D, Zou Y, Zheng X, Zhao G, Tian N, Zheng Z, Peng X, Yang Q, Liang Z, Li Y, Han Y, Stone GW. Bivalirudin versus heparin in patients with or without bail-out GPI use: a pre-specified subgroup analysis from the BRIGHT-4 trial. BMC Med. 2024 Sep 27;22(1):410. doi: 10.1186/s12916-024-03579-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bivalirudin	Peptide	1.75 mg/kg	Intravenous
Comparator	Heparin	Other / unclassified	70 iu/kg	Intravenous

Indications