Study participants
allergic, thrombotic lesions, hepatorenal dysfunction, coronary occlusion lesion, coronary lesions
ACUTE MYOCARDIAL INFARCTION, MULTIPLE ORGAN FAILURE, CARDIOGENIC SHOCK, SINGLE CORONARY ARTERY, AUTOIMMUNE DISEASE
This randomized, open-label, parallel group design study was conducted in our hospital and was registered at ClinicalTrials.gov (Registry No., NCT04120961, 09/10/2019). The study protocol was approved by the Ethics Committee of our hospital (Approval No., KY20190823-05). All procedures complied with the principles laid down in the Declaration of Helsinki, and all participants provided written informed consent. 330 patients enrolled between September 2019 and July 2022 were randomly assigned to one of two groups: the treatment with bivalirudin during operation (control) group (n = 165) and the treatment with bivalirudin during and after operation for 4 h (intervention) group (n = 165). The computer-generated random numbers corresponding to the related group was concealed in an envelope, and was kept by an independent assistant until the treatment was assigned. All investigators were blinded to the randomization sequence. After obtaining written consents from eligible subjects, the independent assistant opened the envelope containing the allocation information. Bivalirudin was administered as an intravenous bolus of 0.75 mg/kg, followed by an infusion of 1.75 mg/kg/h.Consecutive patients aged 18–100 years with de novo coronary lesions, ePCI, and only a single coronary artery treated at this time were considered for enrollment. The following patients were excluded: those who met the diagnostic criteria of acute myocardial infarction, patients with cardiogenic shock, patients with multiple organ failure, patients allergic to contrast agent, patients who do not tolerate dual antiplatelet therapy, patients who do not tolerate anticoagulation agents, recently infected patients, patients with hepatorenal dysfunction, thrombotic lesions of the coronary artery, and/or chronic total coronary occlusion lesion, patients with complex coronary bifurcation requiring a two-stent strategy, patients with severe coronary calcified lesions, patients with percutaneous coronary angioplasty, patients with directional coronary atherectomy or rotational atherectomy, patients undergoing drug-coated balloon treatment, patients with a bioabsorbable vascular scaffold implantation, patients who previously underwent percutaneous coronary intervention, patients with a coronary artery bypass graft, or patients with active stage of autoimmune disease.