Background. Randomized data on the optimal parenteral anticoagulant during percutaneous coronary intervention (PCI) in high bleeding risk (HBR) patients with acute coronary syndromes (ACS) are lacking.
Methods. BRIGHT-HBR is an investigator-sponsored, open-label, randomized controlled trial comparing bivalirudin vs. unfractionated heparin (UFH) monotherapy in HBR patients with ACS undergoing PCI. A total of 5270 HBR patients with a non-ST-elevation acute coronary syndrome (NSTE-ACS) or recent stabilized ST-segment elevation myocardial infarction (STEMI, ≥48 hours after symptom onset) will be randomized 1:1 to bivalirudin or UFH at 70 sites in China. HBR is defined by the Academic Research Consortium (ARC)-HBR criteria. The primary composite endpoint is net adverse clinical events (NACE) at 30 days, the composite of all-cause death, myocardial infarction, stroke, urgent target-vessel revascularization, or BARC types 2, 3 or 5 bleeding, and the major secondary endpoint is BARC types 2, 3 or 5 bleeding. The study is powered to demonstrate that bivalirudin is superior to UFH monotherapy for NACE in ACS patients with HRB at 30 days after PCI.
Conclusions. The BRIGHT-HBR randomized trial aims to provide evidence on whether bivalirudin reduces the incidence of NACE and clinically relevant bleeding compared with UFH monotherapy in patients with ACS who are at HBR undergoing PCI.
Age ≥18 years
Clinical evidence of NSTE-ACS or recent stabilized STEMI (≥48 hours after symptom onset) undergoing PCI
The patient meets the ARC criteria for HBR (≥1 major criterion or ≥2 minor criteria)
The patient or legal representative has been fully informed and written informed consent has been obtained
STEMI patients within 48 hours of symptom onset
CABG or PCI within the prior 6 months, including for the present clinical syndrome
Cardiogenic shock
Coronary artery disease unsuitable for revascularization or requiring CABG
Parallel
Anticoagulant Therapy
DrugThe optimal parenteral anticoagulant during percutaneous coronary intervention (PCI) in high bleeding risk (HBR) patients with acute coronary syndromes (ACS)
Net adverse clinical events (NACE) at 30 days
The composite of all-cause death, MI, stroke, urgent target-vessel revascularization, or BARC types 2, 3 or 5 bleeding
BARC types 2, 3 or 5 bleeding at 30 days
NACE at 12 months
Each individual component of NACE at 30 days and 12 months
Major adverse cardiac and cerebral events (MACCE) at 30 days and 12 months
Composite of all-cause death, MI, stroke, or urgent target-vessel revascularization
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