Study Of Evolocumab On Blood Lipid Level,Clinical Efficacy And Drug Safety In Patients With Coronary Multi-vessel Lesions

Objective: To explore the effects of evolocumab on blood lipid level,clinical efficacy and drug safety in patients with coronary multi-vessel lesions.Methods: This study is a single-center,prospective,randomized controlled study.One hundred patients with coronary multi-vessel lesions admitted to the second Hospital of Hebei Medical University from January2020 to June 2020 were randomly divided into two groups: patients in the evolocumab group(n=50)were treated with evolocumab combined with statins,while patients in the control group(n=50)were treated with statins alone.All the patients were followed up for half a year to observe the effects of evolocumab on blood lipids including low density lipoprotein cholesterol(Low-density lipoprotein cholesterol,LDL-C),triglyceride(Triacylglycerol TG),and lipoprotein a(Lipoprotein a,Lp(a));the incidence of cardiovascular end-point events including cardiogenic death,myocardial infarction,re-hospitalization due to unstable angina pectoris or coronary revascularization,and the adverse reactions of study drugs including gastrointestinal reactions,myalgia,transaminase more than 3 times of the normal upper limit,injection site reactions,new-onset diabetes,neurocognitive effects and so on.All the data were analyzed by SPSS25.0statistical software and two-sided P<0.05 were reported significant.Results:1.There was no significant difference in baseline characteristics with the age,sex,body mass index,cardiovascular risk factors(hypertension,diabetes,smoking),use of statins,use of ezetimibe,use of other cardiovascular drugs(antiplatelet drugs,β-blockers,ACEI/ARB,spironolactone),and creatine kinase(CK),alanine aminotransferase(ALT),aspartate aminotransferase(AST),fasting blood glucose(FPG)and blood lipids [triglyceride,low density lipoprotein cholesterol,lipoprotein(α)](P > 0.05).2.There were 21 patients with two-vessel coronary artery disease in the evolocumab group vs 20 in the control group,and 29 patients with three-vessel coronary artery disease VS 30 in the control group.There were 7 patients with left main lesions,5 patients with chronic total occlusions,6 patients with calcifications,3 patients with coronary artery bifurcation lesion and 23 patients with stent numbers≥2 in the evolocumab group,while 8,4,7,4,22 patients respectively in control group.(P > 0.05).3.LDL-C data: The results of comparison between the two groups showed that the level of LDL-C in the evolocumab group was significantly lower than that in the control group.There were significant differences among different time points(baseline 2.93 ±0.56mmol/L VS 2.91 ±0.58 mmol/L,half-month1.85 ±0.19mmol/L VS 2.87 ±0.30 mmol/L,1 month 1.49 ±0.17mmol/L VS2.84 ±0.54 mmol/L,3 months 1.24 ±0.14mmol/L VS 2.77 ±0.57 mmol/L,half a year 1.06 ±0.27mmol/L VS 2.71 ±0.59 mmol/L,P < 0.0001)(Table 3).The results of variance analysis of repeated measurement design for the LDL-C levels of the two groups at each time point showed that the LDL-C level of the evolocumab group decreased progressively with time,and the difference of LDL-C value between different time points was statistically significant(P <0.05).The LDL-C level decreased by 64% in half a year compared with the baseline,while there was no significant difference in LDL-C level over time in the control group(P > 0.05).4.Clinical efficacy: During the follow-up period,there was 1 patient with heart failure,1 patient with unstable angina pectoris,and 1 patient with coronary revascularization in evolocumab group,while 3,5,3patients respectively in control group.In addition,2 patient in the control group died of cardiovascular death and myocardial infarction respectively.Although there was no significant difference in single cardiovascular event between the two groups(P >0.05),there was significant difference in the incidence of compound adverse cardiovascular events between the two groups(P < 0.05).The incidence of adverse cardiovascular events in the evolocumab group was significantly lower than that in the control group.5.Drug safety: Side effects occurred in 8% of patients in evolocumab group while 12% in control group.There were 2 patients with gastrointestinal reactions both in the evolocumab group and control group,and 2 patients with abnormal liver enzymes both in the evolocumab group and control group,and2 cases of myalgia in the control group.The side effects of study drugs were similar in the two groups.(P > 0.05).Conclusions: Evolocumab combined with statins can not only notebly reduce the level of LDL-C,but also reduce the incidence of cardiovascular endpoint events in patients with Coronary Multi-vessel lesions,furthermore,evolocumab is safe and well tolerated.