| Background:Atherosclerosis is the most common and important type of atherosclerosis,characterized by the deposition of lipid-like substances in the intima of the affected arteries,the accumulation of complex sugars,followed by fibrous tissue hyperplasia and calcium deposits,and lesions in the middle layers of the arteries.Atherosclerosis that occurs in the coronary arteries is called Coronary Atherosclerosis(Coronary Atherosclerotic).In recent years,the incidence and mortality of coronary atherosclerotic(ASCVD)cardiovascular disease in China has been increasing year by year.Current studies have concluded that elevated low-density lipoprotein cholesterol(LDL-C)is the most important initiating factor for the development of atherosclerosis.Therefore,lowering LDL-C is a central goal in the prevention and treatment of coronary atherosclerosis.Currently,statins are the clinically recommended lipidlowering drugs but have limited level of control of LDL-C.Therefore,with the increasing research on ASCVD,non-statin combination lipid control regimens have emerged,but at this stage,there are limited studies on the clinical treatment follow-up of patients using combination drugs for lipid control.Objective:To evaluate the clinical efficacy and safety of PCSK9 inhibitors in combination with statins in patients with ultra-high-risk ASCVD(three branches of coronary artery disease)treated with percutaneous coronary intervention(PCI),and to provide clinical experience in the treatment of the ultra-high-risk ASCVD population.Methods:A total of 266 patients diagnosed with ultra-high-risk ASCVD(three branches of coronary artery disease)and treated with percutaneous coronary intervention(PCI)were retrospectively analyzed in the Department of Cardiovascular Medicine of the First Hospital of Jilin University between January 2020 and June 2021,and the patients were divided into 2 groups according to the different drug regimens: study group(PCSK9 Inhibitor + Rosuvastatin group,n=139)and the control group(Rosuvastatin group,n=127).After 12 weeks of dosing,lipid changes(including LDL-C,total cholesterol TG,triglyceride TC,HDL-C),major adverse cardiovascular events(MACE)occurrence(including non-cardiovascular death,hemorrhagic stroke,heart failure rehospitalization,unanticipated rehospitalization for angina,unanticipated PCI),and major clinical adverse events(AEs)(injection site reactions,myalgia,neurocognitive events,new onset diabetes mellitus,and more than 3-fold increase in transaminases)were recorded.All data were analyzed by applying SPSS25.0 statistical analysis software,and P < 0.05 was statistically significant.Results:(1)Among 266 patients,127(47.74%)were in the control group and 139(52.26%)in the study group;the general conditions of the two groups,including age,gender,body mass index BMI,combined hypertension,type 2 diabetes,history of ischemic stroke,smoking history,BMI,use of antiplatelet aggregation drugs,use of statins,liver function,kidney function,and fasting glucose,no significant difference,p > 0.05.(2)In the comparison of coronary artery lesion revascularization,all three lesions accounted for 100% of patients in the study group and control group;among them,the history of previous coronary artery revascularization accounted for 47.9%(61 cases)in the control group and 39.6%(55 cases)in the study group;regarding the serious lesions(including CTO and left main stem lesions)found in this coronary angiography,37%(47 cases)in the control group and The number of cases treated with PCI was 151.8%(193 cases)in the control group and 136.7%(190 cases)in the study group.There was no statistical difference between the study group and the control group in terms of hemodynamic reconstruction,coronary lesions and interventions(p>0.05).(3)Comparing the lipid levels between the two groups: comparing before and after treatment within the two groups,the TG,TC,and LDL-C levels in the control group decreased significantly after treatment compared to before treatment(p < 0.05),HDL-C in the control group increased after treatment compared to before treatment(p< 0.05),TG,TC,and LDL-C in the study group decreased significantly after treatment compared to before treatment(p < 0.01),and HDL-C in the study group increased after treatment compared to increased after treatment than before treatment(p < 0.05);compared between the two groups,TG,TC and LDL-C levels in the study group decreased significantly after treatment than in the control group(p < 0.01),among which LDL-C decreased the most,with a statistically significant difference(p< 0.01);after treatment,the LDL-C compliance rate in the study group was significantly higher than that in the control group,with a statistically significant difference(p < 0.01);confirmed that PCSK9 inhibitor combined with Rosuvastatin is important for the control of lipid level in ASCVD patients.Single-factor logistic regression analysis showed that creatinine,serum sodium,TC,LDL-C,and HDL-C were potential influencing factors for lipid attainment in the study group;multi-factor logistic regression analysis identified TC as an independent influencing factor for lipid attainment in the study group.(4)MACE incidence: the incidence of MACE was 15.0% in the study group and5.0% in the control group;the incidence of MACE in the study group was lower than that in the control group(p<0.05);among them,the incidence of unanticipated rehospitalization for angina was reduced in the study group,p<0.05.One-way logistic regression analysis showed that women,age,alcohol consumption,and blood sedimentation in the study group were potential risk factors for the occurrence of MACE;multi-factor logistic regression analysis,determined that the study group was an independent risk factor for MACE events.It indicates that the study group is an independent protective factor for the risk of MACE occurrence.(5)There was no statistical difference between the two groups for adverse reactions AE.Conclusion:(1)PCSK9 inhibitors applied to patients with ultra-high-risk ASCVD and parallel percutaneous coronary intervention can further reduce lipid levels on the basis of lipid lowering by resulvastatin,with a significant reduction in LDL-C.(2)PCSK9 inhibitors combined with statins can reduce the incidence of MACE in patients with ultra-high-risk ASCVD.(3)PCSK9 inhibitors combined with statin lipid-lowering therapy did not increase adverse effects. |
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