Efficacy And Safety Of Indobufen In Coronary Heart Disease Patients Treated With PCI

Objectives: To investigate the efficacy and safety of indobufen and aspirin for antiplatelet therapy in patients with coronary heart disease after PCI.Methods: This study is a prospective randomized controlled trial.Patients undergoing percutaneous coronary intervention with a Drug eluting stent for coronary heart disease were randomly assigned(1:1)to 100 mg indobufen bid plus 75 mg clopidogrel qd or 100 mg aspirin plus 75 mg clopidogrel qd for 12 months.The primary endpoint was major adverse cardiovascular events(MACE)including all-cause death,nonfatal myocardial infarction,ischemic stroke,definite or possible stent thrombosis and recurrent angina.The safety end point was Bleeding Academic Research Consortium(BARC)type 2,3,or 5bleeding.The incidence of(MACE)and bleeding events were compared between the two groups.Results: In this study,In this study,91 patients were included and randomly divided into indobufen group(n = 44)and aspirin group(n = 47).Following up for 12 months,5 cardiovascular events occurred in the indobufen group,all of which were recurrent angina.A total of 9 cardiovascular events occurred in the aspirin group,including 2 cases of ischemic stroke,1 case of death from cerebral hemorrhage,and 6 cases of recurrent angina.There was no statistical difference in the incidence of major cardiovascular adverse events between the two groups(incidence,11.4% vs 19.1%,hazard ratio 0.57,95%CI0.19-1.70,P=0.305).BARC type 2,3 or 5 bleeding did not differ significantly between the Indobufen group and the aspirin group(incidence,2.3% vs 4.3%,hazard ratio 0.53,95%CI 0.05-5.85,P=0.599)Conclusions: For patients with coronary heart disease after PCI,indobufen plus clopidogrel was not inferior to aspirin plus clopidogrel in the antiplatelet therapy.