依洛尤单抗与阿利西尤单抗治疗老年冠脉多支病变高危ASCVD的临床研究OA

Objective To compare the lipid-lowering efficacy and safety of evolocumab injection versus alirocumab injection,in elderly patients with multivessel coronary artery disease and high-risk atherosclerotic cardiovascular disease(ASCVD).Methods Elderly patients with multivessel coronary artery disease and high-risk ASCVD were selected and randomly divided into treatment group and control group.Both groups routinely received secondary prevention medications for coronary heart disease and adopted the same oral regimen:ezetimibe tablets(10 mg once daily)combined with atorvastatin calcium tablets(20 mg once daily).On this basis,the control group additionally received subcutaneous alirocumab injection(75 mg every 2 weeks),and the treatment group additionally received subcutaneous evolocumab injection(140 mg every 2 weeks).The course of treatment for both groups was 6 months.Lipid-lowering efficacy,blood lipid levels,coronary plaque indices,cardiac function indices,vascular inflammatory markers,adverse drug reactions and major adverse cardiovascular events(MACEs)were compared between the two groups.Results A total of 132 patients were screened,and 110 were enrolled(55 per group).All completed the follow-up with no loss to follow-up.After treatment,the total effective rates of lipid-lowering therapy in control group and treatment group were 76.36％(42 cases/55 cases)and 90.91％(50 cases/55 cases),respectively;the low-density lipoprotein cholesterol(LDL-C)target achievement rates were 78.18％(43 cases/55 cases)and 92.73％(51 cases/55 cases),respectively;total cholesterol(TC)levels were(4.31±0.85)and(3.82±0.79)mmol·L-1,respectively;triglyceride(TG)levels were(1.31±0.35)and(1.09±0.31)mmol·L-1,respectively;LDL-C levels were(1.48±0.42)and(1.12±0.38)mmol·L-1,respectively;high-density lipoprotein cholesterol(HDL-C)levels were(1.51±0.34)and(1.72±0.33)mmol·L-1,respectively;lipoprotein(a)[Lp(a)]levels were(298.64±59.73)and(275.19±54.37)mg·L-1,respectively;minimum lumen area(MLA)was(5.92±1.28)and(6.65±1.31)mm2,respectively;percent atheroma volume(PAV)was(53.18±9.15)％ and(47.52±8.66)％,respectively;cardiac output(CO)was(4.55±0.58)and(4.92±0.62)L·min-1,respectively;stroke volume(SV)was(53.44±5.63)and(55.86±5.27)mL,respectively;left ventricular ejection fraction(LVEF)was(49.65±5.81)％ and(52.88±5.69)％,respectively;high mobility group box 1(HMGB1)was(4.43±0.98)and(3.82±0.91)mg·L-1,respectively;serum amyloid A1(SAA1)was(225.43±42.18)and(198.76±41.55)μg·L-1,respectively;C-C motif chemokine ligand 19(CCL19)was(68.77±9.45)and(64.15±9.88)ng·L-1,respectively.The treatment group outperformed the control group on all the above indicators,with all differences statistically significant(all P＜0.05).The adverse drug reactions in both groups were gastrointestinal discomfort,injection site reactions and newly developed diabete.The overall incidence of adverse drug reactions was 14.55％(8 cases/55 cases)in control group and 10.91％(6 cases/55 cases)in treatment group,with no statistically significant difference between the two groups(P＞0.05).The incidence of MACEs was 14.55％(8 cases/55 cases)in control group and 3.64％(2 cases/55 cases)in treatment group,with statistically significant differences(P＜0.05).Conclusion For elderly patients with multi-vessel coronary artery disease and high-risk ASCVD,the evolocumab injection-based regimen is superior to the alirocumab injection-based regimen in lowering LDL-C,regressing coronary plaques,and reducing MACEs,with comparable safety.