Effect of moderate-dose statins combined with PCSK9 inhibitors on coronary plaques in patients with acute coronary syndrome
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摘要: 目的 分析中等剂量他汀联合依洛尤单抗对急性冠状动脉综合征患者冠状动脉(冠脉)斑块的影响。方法 纳入2023年3月1日—2024年5月29日新疆医科大学第四附属医院符合纳入与排除标准的急性冠脉综合征患者92例，分为对照组(46例)和研究组(46例)。其中，对照组服用20 mg阿托伐他汀钙，每晚睡前1次口服，持续用药26周；研究组在上述他汀类药物基础上给予140 mg依洛尤单抗注射液，每2周1次，皮下注射，持续用药26周。观察指标：①血管内超声(IVUS)显示的冠脉斑块面积变化情况；②甘油三酯(TG)、总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)变化水平及LDL-C达标率；③随访期间主要心血管不良事件发生情况；④随访期间不良反应发生情况。结果 治疗26周后，IVUS显示，研究组冠脉斑块面积显著小于对照组[(6.81±2.15) mm2vs. (7.72±2.17) mm2，P<0.05]，且两组斑块面积均小于治疗前(均P<0.05)；研究组TG[(1.57±0.65) mmol/L vs. (2.02±0.70) mmol/L，P<0.05]、TC[(2.23±0.87) mmol/L vs. (3.90±1.01) mmol/L，P<0.05]及LDL-C[(1.38±0.50) mmol/L vs. (1.99±0.94) mmol/L，P<0.05]均显著低于对照组；研究组LDL-C达标率显著高于对照组(80.43% vs. 39.13%，P<0.05)。随访期间两组主要心血管不良事件和不良反应发生率均差异无统计学意义。结论 中等剂量他汀类药物联合PCSK9抑制剂依洛尤单抗可降低急性冠脉综合征患者冠脉斑块面积，实现斑块逆转，显著降低患者血脂水平，在短期应用中具有一定的安全性。Abstract: Objective To evaluate the effect of moderate-dose statins combined with evolocumab on coronary plaques in patients with acute coronary syndrome (ACS).Methods A total of 92 patients with ACS who met the inclusion and exclusion criteria were enrolled from The Fourth Affiliated Hospital of Xinjiang Medical University from March 1, 2023 to May 29, 2024. Patients were randomly assigned to either the control group (n = 46), receiving atorvastatin calcium 20 mg orally once daily at bedtime for 26 weeks, or the study group (n = 46), receiving the same statin regimen plus subcutaneous evolocumab 140 mg every two weeks for 26 weeks. Observation indicators: 1. Changes in coronary plaque area assessed by intravascular ultrasound (IVUS); 2. Changes in triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) levels, and LDL-C compliance rate; 3. The incidence of major cardiovascular adverse events during follow-up; 4. The occurrence of adverse reactions during follow-up.Results After 26 weeks of treatment, IVUS revealed that the coronary plaque area in the study group was significantly smaller than in the control group (6.82±2.15 mm2 vs. 7.72±2.17 mm2, P<0.05), with both groups showing a significant reduction from baseline (both P<0.05). The study group had lower levels of TG (1.57±0.65 mmol/L vs. 2.02±0.70 mmol/L, P<0.05), TC (2.23±0.87 mmol/L vs. 3.90±1.01 mmol/L, P<0.05), and LDL-C (1.38±0.50 mmol/L vs. 1.99±0.94 mmol/L, P<0.05) compared to the control group. The LDL-C compliance rate was significantly higher in the study group than in the control group (80.43% vs. 39.13%, P<0.05). There was no significant difference in the occurrence of major cardiovascular adverse events or adverse reactions between the two groups during follow-up.Conclusion Moderate-dose dose statins combined with the PCSK9 inhibitor evolocumab significantly reduces coronary plaque area, induces plaque regression, and effectively lowers blood lipid levels in patients with ACS, with good short-term safely.
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表 1 基线资料比较
Table 1. Comparison of baseline data
例(%), X±S 项目 对照组(46例) 研究组(46例) t/χ2 P 男性 34(73.91) 37(80.43) 0.555 0.456 年龄/岁 61.48±11.46 57.50±10.32 1.750 0.084 吸烟 15(32.60) 22(47.82) 2.215 0.137 饮酒 6(13.04) 8(17.39) 0.337 0.562 糖尿病 12(26.08) 14(30.43) 0.214 0.643 高血压 23(50.00) 16(34.78) 2.181 0.140 目标斑块所在血管 右冠脉 15(32.61) 13(28.26) 0.205 0.650 前降支 19(41.30) 18(39.13) 0.045 0.832 回旋支 8(17.39) 10(21.74) 0.276 0.599 其他 4(8.70) 5(10.87) 0.123 0.726 冠脉斑块面积/mm2 7.96±2.20 7.93±2.19 0.064 0.949 TG/(mmol/L) 2.65±0.86 2.69±0.79 -0.253 0.801 TC/(mmol/L) 4.66±0.96 4.72±1.16 -0.267 0.790 LDL-C/(mmol/L) 3.05±0.91 3.11±1.06 -0.290 0.773 TG：甘油三酯；TC：总胆固醇；LDL-C：低密度脂蛋白胆固醇。 
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表 2 对照组和研究组患者治疗前后冠脉斑块面积比较
Table 2. Comparison of coronary plaque area between two groups before and after treatment
mm2, X±S 组别 治疗前 治疗26周后 t P 对照组(46例) 7.96±2.20 7.72±2.17 15.27 < 0.001 研究组(46例) 7.93±2.19 6.81±2.15 22.912 < 0.001 t 0.064 2.011 P 0.949 0.047
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表 3 对照组和研究组患者治疗后血脂情况比较
Table 3. Comparison of blood lipid between the two groups
mmol/L, 例(%), X±S 组别 TG TC LDL-C LDL-C达标 对照组(46例) 2.02±0.70 3.90±1.01 1.99±0.94 18(39.13) 研究组(46例) 1.57±0.65 2.23±0.87 1.38±0.50 37(80.43) t/χ2 3.206 8.528 3.852 16.320 P 0.002 < 0.001 < 0.001 < 0.001
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表 4 对照组和研究组患者MACE发生情况比较
Table 4. Comparison of MACE occurrence between the two groups
例(%) 组别 复发心绞痛 急性心肌梗死 卒中 全因死亡 对照组(46例) 2(4.34) 1(2.17) 0 0 研究组(46例) 1(2.17) 0 0 1(2.17) χ2 0.345 1.011 1.011 P 0.557 0.315 0.315
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表 5 两组患者不良反应发生情况比较
Table 5. Comparison of adverse reactions between the two groups
例(%) 组别 局部注射反应 肌肉酸痛 肝肾功能异常 新发糖尿病 对照组(46例) 0 2(4.34) 1(2.17) 0 研究组(46例) 1(2.17) 1(2.17) 0 0 χ2 1.011 0.345 1.011 P 0.315 0.557 0.315
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