This is a randomized, open label, cohort study, in which a total of 100 patients will be enrolled and randomly assigned to receive bivalirudin or heparin in a 1:1 ratio during short-term intervention of non-infarction related artery for acute ST-segment elevation myocardial infarction after emergency percutaneous coronary intervention. NACE, MACE, any type of BARC bleeding, stent thrombosis will be evaluated in 30 days and 6 months after recruitment.
The 2017 guideline gives a class IIA recommendation ('should be considered') for complete revascularisation in patients presenting with STEMI and multivessel disease, which is approximately 50% of the STEMI population. Staged multivessel PCI during hospitalization (3-5 days after PPCI) is common in contemporary practice. Patients undergoing primary PCI should receive enhanced antithrombotic therapy, includes DAPT and and parenteral anticoagulant, which caused an increased bleeding risk. In addition, repeated use of heparin in a short time may increase the incidence of HIT. Direct thrombin inhibitor bivalirudin, demonstrated a reduced risk of bleeding and an overall favorable profile including reduced NACE. This is a randomized, open label, cohort study, which is aimed to investigate the safety and efficacy of bivalirudin during short-term intervention of non-infarction related artery for acute ST-segment elevation myocardial infarction after emergency percutaneous coronary intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Bivaliruding 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until 4 hours after PCI. A prolonged infusion of 0.2 mg/kg/h for ≤20h could be considered at the operator's discretion. It is recommended that ACT be monitored 5 minutes after the first administration, and if ACT is \<225 s (Hemotec method), intravenous injection of 0.30 mg/kg of bivalirudin should be administered.
Heparin is dosed at 100 U/kg. ACT is monitored 5 min after the first administration, and if the ACT \<225 s (Hemotec method), an intravenous injection of heparin should be administered by need.
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
RECRUITINGNet adverse clinical events (NACE)
A composite of major adverse cardiac or cerebral events (all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke) or any bleeding as defined by BARC definition (grades 1-5). BARC=Bleeding Academic Research Consortium
Time frame: 30 days
Major adverse cardiac and cerebral events (MACE)
A composite of all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke
Time frame: 30 days
Major adverse cardiac and cerebral events (MACE)
A composite of all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke
Time frame: 6 months
Bleeding
Bleeding as defined by BARC definition (grades 1-5). Bleeding was considered medically actionable if BARC types 2-5 and was considered major if BARC types 3-5 occurred. BARC=Bleeding Academic Research Consortium
Time frame: 30 days
Bleeding
Bleeding as defined by BARC definition (grades 1-5). Bleeding was considered medically actionable if BARC types 2-5 and was considered major if BARC types 3-5 occurred. BARC=Bleeding Academic Research Consortium
Time frame: 6 months
Stent thrombosis
Stent thrombosis as defined by ARC ARC=Academic Research Consortium
Time frame: Hospitalization
Stent thrombosis
Stent thrombosis as defined by ARC ARC=Academic Research Consortium
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Time frame: 30 days
Stent thrombosis
Stent thrombosis as defined by ARC ARC=Academic Research Consortium
Time frame: 6 months