| Objective To investigate the efficacy and safety of moderate strength statin combined with ezetimibe plus Evolocumab in the treatment of patients with single-vessel coronary artery disease.Methods A total of 170 patients diagnosed with coronary CTA in our hospital as single-vessel(moderate or above stenosis)lesions and meeting CT-FFR≥0.75 were selected from June 2021 to December 2022 and randomly divided into two groups.On the basis of conventional secondary prevention drugs for coronary heart disease(excluding lipid-lowering drugs),the control group was treated with statin combined with ezeimibe.The experimental group was treated with statin,Ezetimibe combined with Evolocumab.There were no significant differences in baseline data(such as age,gender,BMI,etc.),lipid levels(TG,TC,LDL-C,HDL-C),Lp(a)and hs CRP between the two groups before treatment.The treatment observation period was 24 weeks.The primary endpoint was the changes of blood lipid,Lp(a),hs CRP and MACE events before and after treatment,while the secondary endpoint was the occurrence of adverse reactions.Results 1.A total of 180 patients were enrolled in the study,among which 22 patients did not fully participate,resulting in a total of 158 patients included in the study,consisting of 78males(49.4%)and 80 females(50.6%).The mean age of all patients was 60.5 years ± 9.5years,and they were divided into an experimental group of 80(50.6%)and a control group of78(49.4%)according to treatment methods.There was no statistically significant difference(P>0.05)in the baseline data of age,gender,BMI,smoking history,peripheral artery history,hypertension history,and diabetes history between the two groups.2.Before treatment,the TG level in the experimental group was 1.55(0.99,2.39)mmol/L,and in the control group it was 1.56(0.92,2.5)mmol/L.There was no significant difference between the two groups(P=0.968).After 4,12,and 24 weeks of treatment,the TG levels in the experimental group were 1.15(0.8,1.48)mmol/L,0.92(0.65,1.17)mmol/L,and 0.75(0.58,1.02)mmol/L,respectively,while in the control group they were 1.37(0.87,1.69)mmol/L,1.14(0.71,1.47)mmol/L,and 1.02(0.75,1.26)mmol/L,respectively.Overall,the TG levels in the experimental group showed a significant decrease compared to the previous time point(P<0.05)at all time points,while in the control group the TG levels showed a significant decrease compared to the previous time point(P<0.05)only after 24 weeks of treatment.During the treatment process,the experimental group was significantly better than the control group.3.Before treatment,the TC level in the experimental group was 3.34(2.58,3.8)mmol/L,and in the control group it was 3.47(2.66,4.23)mmol/L.There was no significant difference between the two groups(P=0.400).After 4,12,and 24 weeks of treatment,the TC levels in the experimental group were 3.08(2.64,3.49)mmol/L,2.69(2.1,3.43)mmol/L,and2.3(1.87,2.94)mmol/L,respectively,while in the control group they were 3.28(2.85,3.60)mmol/L,3.05(2.48,3.64)mmol/L,and 2.71(2.25,3.28)mmol/L,respectively.Overall,both the experimental and control groups showed a significant decrease in TC levels compared to the previous time point(P<0.05),with the experimental group being better than the control group.4.Before treatment,the HDL-C level in the experimental group was 1.36(1.17,1.63)mmol/L,and in the control group it was 1.40(1.20,1.65)mmol/L.There was no significant difference between the two groups(P=0.777).After 4,12,and 24 weeks of treatment,the HDL-C levels in the experimental group were 1.56(1.32,1.76)mmol/L,1.70(1.34,2.00)mmol/L,and 1.76(1.49,2.10)mmol/L,respectively,while in the control group they were1.50(1.28,1.66)mmol/L,1.60(1.25,1.91)mmol/L,and 1.69(1.46,2.01)mmol/L,respectively.Overall,both the experimental and control groups showed a significant increase in HDL-C levels compared to the previous time point(P<0.05),but there was no significant difference between the experimental and control groups.5.Before treatment,the LDL-C level in the experimental group was 2.22(1.44,2.86)mmol/L,and in the control group it was 2.19(1.68,2.66)mmol/L.There was no significant difference between the two groups(P=0.876).After 4,12,and 24 weeks of treatment,the LDL-C levels in the experimental group were 1.10(0.75,1.45)mmol/L,0.87(0.66,1.1)mmol/L,and 0.64(0.46,0.79)mmol/L,respectively,while in the control group they were 1.95(1.22,2.50)mmol/L,1.44(0.90,1.96)mmol/L,and1.41(0.90,1.58)mmol/L,respectively.Overall,both the experimental and control groups showed a significant decrease in LDL-C levels compared to the previous time point(P<0.05),with the experimental group being better than the control group.6.After 24 weeks of treatment,with<1.4 mmol/L and a decrease in blood lipids by more than 50% as the standard,the compliance rate in the experimental group was 66(82.5%),while in the control group it was 27(34.6%).The compliance rate in the experimental group was significantly better than that in the control group(P<0.001).7.Before treatment,among the 40 patients with Lp(a)>0.3g/L,there were 22(55%)in the experimental group and 18(45%)in the control group.The Lp(a)level in the experimental group was 0.35(0.34,0.36)g/L,and in the control group it was 0.37(0.34,0.38)g/L.There was no significant difference between the two groups(P=0.248).After 24 weeks of treatment,the Lp(a)level in the experimental group decreased from 0.35(0.34,0.36)to 0.11(0.05,0.14),while in the control group it decreased from 0.37(0.34,0.38)g/L to 0.32(0.29,0.34)g/L.The decrease in Lp(a)in the experimental group was significant(P<0.05),while in the control group it was not statistically significant.The Lp(a)level in the experimental group was lower than that in the control group(P<0.001).8.There was no significant difference in hs CRP levels between the two groups before treatment(P>0.05),and there was still no significant difference after 4,12,and 24 weeks of treatment(P>0.05).9.After 24 weeks of lipid-lowering treatment,the safety of the experimental group was better than that of the control group in terms of cardiovascular death,recurrent angina pectoris,liver function abnormalities,myalgia,new-onset diabetes,and neurocognitive events.Conclusion 1.This study compared the level changes of TG,TC,LDL-C,HDL-C and Lp(a)before and after treatment,and followed up to record the occurrence of adverse reactions and MACE events,reflecting the value of CT-FFR in guiding clinical evaluation of coronary hemodynamics;2.This study confirmed that the two groups have a good effect on reducing blood lipids,but the triple drug(statin+ezetimibe+PCSK9 inhibitor)has significant advantages,which is significantly better than the control group in terms of the reduction rate and the rate of reaching the standard;3.This study found that the addition of PCSK9 inhibitor in the 24 week observation period of treatment had less adverse reactions such as liver damage,myalgia,and new onset diabetes than statin group,and no MACE event occurred,with high safety,which brought a new choice for high-risk ASCVD patients with LDL-C failure or statin intolerance.It is believed that there is a good development prospect in the future. |
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