A Comparative Study Of The Effect Of PCSK9 Inhibitors On Bleeding And Coagulation In Patients After Percutaneous Coronary Intervention

Background:PCSK9(proprotein convertase subtilisin/Kexin type 9)inhibitor is a novel lipid-lowering drug,and clinical studies have shown its high lipid-lowering effect.In addition,PCSK9 inhibitors may also affect coagulation and platelet activation.However,since its launch,there has been little research on Chinese patients,and elderly patients have poorer vascular conditions and more complex conditions themselves,leading to a higher risk of bleeding during the use of antiplatelet drugs.Purpose:This study provides additional clinical evidence for the use of PCSK9 inhibitors by comparing whether the application of PCSK9 inhibitors affects bleeding and coagulation in ASCVD(atherosclerotic cardiovascular disease)patients after percutaneous coronary intervention(PCI)and by comparing the coagulation function and platelet function of patients with ASCVD after PCI treatment in elderly and non-elderly patients with PCSK9 inhibitors.Methods: In this study,patients(18 years old ≤ age ≤ 85 years old)who met the diagnostic criteria for ASCVD and were seen in the Department of Cardiology of the People’s Hospital of Liaonig Province from October 2020 to October 2022 and underwent PCI were enrolled(480 patients were finally enrolled).All patients were treated with moderate doses of statin + ezetimibe,PCSK9 inhibitors for lipid-lowering,antiplatelet,antihypertensive and glucose-lowering drugs were given according to the relevant guidelines and the need of the disease for secondary prevention.The trial group and control group were divided according to whether PCSK9 inhibitors were applied or not.Referring to the World Health Organization criteria,patients in the trial group were divided into an elderly group aged ≥60 years and a non-elderly group aged <60 years.Information on patients’ past medical history,gender,age,body mass index,history of smoking and drinking,and medication use was collected.Platelet aggregation(ADP),platelet aggregation(AA),prothrombin time,activated partial thromboplastin time,and fibrinogen in coagulation were measured during hospitalization and at 6 months postoperatively in the final enrolled patients,respectively.The results of some laboratory tests(platelet count,glutamic aminotransferase,glutamic oxalacetic aminotransferase,creatinine,creatine kinase)were observed for MACE events(including: all-cause death,recurrent myocardial infarction,recurrent angina,ischemic stroke),and bleeding events(using BARC bleeding classification criteria).Results: A total of 480 patients who were post-PCI and met the diagnostic criteria for ASCVD were finally enrolled.(1)There was no statistical difference in baseline information,platelet count,platelet aggregation function and coagulation function between the two groups during hospitalization;the incidence of MACE events and the incidence of bleeding events were similar and not statistically different between the test and control groups.(2)At 6 months postoperatively,patients in the test and control groups showed statistically significant differences in platelet count,platelet aggregation function ADP,AA,PT,and Fib;the incidence of MACE events and bleeding events were higher in the test group,but the differences were not statistically significant.(3)There were no statistical differences in baseline information,platelet count,platelet aggregation function and coagulation function between the elderly and non-elderly groups during hospitalization;the incidence of MACE events and the incidence of bleeding events were similar and not statistically different.(4)At 6 months postoperatively,there were statistically significant differences in platelet count,platelet aggregation function ADP,AA,PT,APTT,and Fib between patients in the elderly and non-elderly groups;the incidence of MACE events in the elderly group was similar to that in the non-elderly group,and the incidence of bleeding events was higher than that in the non-elderly group,but the differences were not statistically significant.Conclusions: PCSK9 inhibitors affect the bleeding and coagulation function of patients after PCI.The use of PCSK9 inhibitors can inhibit platelet aggregation,which can improve the coagulation index and thus reduce the risk of cardiovascular disease without increasing the risk of bleeding,and there is no additional risk of bleeding in elderly patients after PCI with PCSK9 inhibitors.