Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors have been demonstrated to produce significantly greater reduction in LDL cholesterol levels and cardiovascular events than standard statin therapy. However, evidence on the impact of PCSK9 inhibitors on coronary plaque composition and morphology is limited. In this open-label randomized study, eligible patients with intermediate coronary lesions and elevated LDL cholesterol values were randomized to either alirocumab 75 mg Q2W plus statin (atorvastatin 20 mg/day or rosuvastatin 10 mg/day) therapy or standard care. Optical coherence tomography (OCT) assessments for target lesions were obtained at baseline and at 36 weeks of follow-up. LDL cholesterol levels were significantly decreased in both the alirocumab and standard care arms, whereas the absolute reduction in LDL cholesterol was significantly greater in patients treated with alirocumab (1.72 ± 0.51 vs. 0.96 ± 0.59, P < 0.0001). Compared with standard care, the addition of alirocumab to statins was associated with significantly greater increases in minimum fibrous cap thickness (18.0 [10.8–29.2] μm vs 13.2 [7.4–18.6] μm; P = 0.029), greater increases in minimum lumen area (0.20[0.10–0.33] mm2 vs 0.13 [0.12–0.24] mm2; P = 0.006) and a greater diminution in maximum lipid arc (15.1̊ [7.8–24.5] vs. 8.4̊ [2.0–10.5]; P = 0.008). The addition of alirocumab to statins can not only provide additional LDL cholesterol lowering effects but also have a potential role in promoting a more stable plaque phenotype. ClinicalTrials.gov Identifier: NCT04851769 . Registered 2 Mar 2019.

中文翻译：

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光学相干断层扫描评估alirocumab对冠状动脉疾病患者冠状动脉斑块的影响

与标准他汀类药物治疗相比，前蛋白转化酶枯草杆菌蛋白酶 9 型 (PCSK9) 抑制剂已被证明可显着降低 LDL 胆固醇水平和心血管事件。然而，关于 PCSK9 抑制剂对冠状动脉斑块组成和形态影响的证据有限。在这项开放标签随机研究中，符合条件的具有中等冠状动脉病变和 LDL 胆固醇值升高的患者被随机分配接受 alirocumab 75 mg Q2W 加他汀类药物（阿托伐他汀 20 mg/天或瑞舒伐他汀 10 mg/天）治疗或标准治疗。在基线和随访 36 周时获得目标病变的光学相干断层扫描 (OCT) 评估。alirocumab 和标准护理组的 LDL 胆固醇水平显着降低，而在接受 alirocumab 治疗的患者中，LDL 胆固醇的绝对降低显着更大（1.72 ± 0.51 对 0.96 ± 0.59，P < 0.0001）。与标准治疗相比，在他汀类药物中添加 alirocumab 与最小纤维帽厚度显着增加相关（18.0 [10.8-29.2] μm vs 13.2 [7.4-18.6] μm；P = 0.029），最小管腔面积增加更大（0.20[0.10–0.33] mm2 vs 0.13 [0.12–0.24] mm2；P = 0.006）和最大脂质弧的更大减小（15.1̊ [7.8–24.5] vs. 8.4̊ [2.0–10.5]；P = 0.008 ）。在他汀类药物中添加 alirocumab 不仅可以提供额外的 LDL 胆固醇降低作用，而且在促进更稳定的斑块表型方面具有潜在作用。ClinicalTrials.gov 标识符：NCT04851769。2019 年 3 月 2 日注册。