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

Conditions

ST Elevation Myocardial Infarction

Keywords

Primary percutaneous coronary intervention, anticoagulant agents, bivalirudin, heparin

Brief 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.

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.

2025-09-30

10.1186/s12916-025-04374-7

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

Xiaolin Su, Miaohan Qiu, Chao Gu, Xiuhui Yang, Bin Liu et al. (16 authors)

PLoS Medicine2025-07-23

10.1371/journal.pmed.1004679

Bivalirudin versus heparin in patients with or without bail-out GPI use: a pre-specified subgroup analysis from the BRIGHT-4 trial.

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.

2024-09-271 citations

10.1186/s12916-024-03579-6

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.

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.

2022-11-0666 citations

10.1016/s0140-6736(22)01999-7

Rationale and Design of a Randomized Controlled Trial of Bivalirudin with a Prolonged High-Dose Infusion Versus Heparin Monotherapy During Primary Percutaneous Coronary Intervention in Patients with Acute ST-Segment Elevation Myocardial Infarction: The BRIGHT-4 Trial

Zhenyang Liang, Yi Li, Gregg W. Stone, Yaling Han

Cardiology Discovery2022-08-194 citations

10.1097/cd9.0000000000000068

Interventions

DRUGBivalirudin

Bivaliruding 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until 2-4 hours after PCI. It is recommended that ACT be monitored 5 minutes after the first administration, and if ACT is \<225 s (Hemotec method), intravenous injection of 0.35 mg/kg of bivalirudin should be administered, and the ACT re-checked to ensure it is \>225 seconds.

DRUGunfractionated Heparin

Heparin 70 U/kg is started before coronary angiography. ACT is monitored 5 min after the first administration, and if the ACT \<225 s (Hemotec method), an intravenous injection of 1000 U of heparin is administered, and the ACT re-checked to ensure it is \>225 seconds.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

Inclusion criteria

* Any age; * STEMI patients undergoing primary PCI with ST elevation≥1mm in≥2 contiguous leads or new LBBB with symptom onset 48h; * Patients requiring staged revascularization of non-culprit vessels within 30 days may be enrolled. In such cases the same antithrombotic agents and PCI procedures must be used in the staged procedure consistent with the index procedure PCI, in particular the assigned antithrombin agent heparin vs. bivalirudin); * Dual antiplatelet drugs must be administrated according to guidelines before PCI (loading doses and maintenance doses of aspirin and clopidogrel or ticagrelor); * The subject or legal representative has been informed of the nature of the study, understood the provisions of the protocol, was able to ensure adherence, and signed informed consent.

Exclusion criteria

* Not suitable for emergency primary PCI; * STEMI treated by thrombolysis; * Patients received heparin, LMWH, fondaparinux, bivalirudin, or GPI within 48 hours before the index PCI; * Mechanical complications (such as ventricular septal rupture, papillary muscle rupture with acute mitral regurgitation, etc.); * Known allergy or contraindications to heparin, bivalirudin, aspirin, or both clopidogrel and ticagrelor * Patients in whom the investigators consider inappropriate to participate in this study (eg, have participated in another drug/instrument study or undergoing another drug/instrument study).

Design outcomes

Primary

Measure	Time frame	Description
Composite of all-cause death or BARC type 3~5 bleeding	30 days	BARC=Bleeding academic research consortium

Secondary

Measure	Time frame	Description
BARC type 3-5 bleeding	30 days	BARC=Bleeding academic research consortium
Major adverse cardiac and cerebral events (MACE)	30 days	MACE is defined as a composite of all cause death, recurrent myocardial infarction, stroke or ischemic driven target vessel revascuarlization
Net adverse clinical events (NACE)	30 days	NACE is defined as a composite of MACE or BARC type 3-5 bleeding
All cause mortality	30 days	—
BARC type 2-5 bleeding	30 days	BARC=Bleeding academic research consortium
Stent thrombosis	30 days	Definite or probable stent thrombosis according to Academic Research Consortium
Thrombocytopenia	30 days	defined as platelet counts less than 150\*10\^9/L after treatment
Composite of all-cause death or BARC type 2-5 bleeding	30 days	BARC=Bleeding academic research consortium

Countries

China

Outcome results

None listed