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阿利西尤单抗对冠状动脉疾病患者冠状动脉钙化的影响。

Effect of Alirocumab on Coronary Calcification in Patients With Coronary Artery Disease.

作者信息

Gao Fei, Li Yue Ping, Ma Xiao Teng, Wang Zhi Jian, Shi Dong Mei, Zhou Yu Jie

机构信息

Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.

出版信息

Front Cardiovasc Med. 2022 May 6;9:907662. doi: 10.3389/fcvm.2022.907662. eCollection 2022.

Abstract

BACKGROUND

Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors have been documented with significantly reduction in LDL cholesterol levels and cardiovascular events. However, evidence regarding the impact of PCSK9 inhibitors on coronary calcification is limited.

METHODS

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 statin therapy. Calcium score based on coronary computed tomographic angiography at baseline and follow up were compared.

RESULTS

Compared with baseline levels, LDL cholesterol were significantly decreased in both groups, while the absolute reduction of LDL cholesterol levels were higher in patients treated with alirocumab (1.69 ± 0.52 vs. 0.92 ± 0.60, < 0.0001). Additionally, patients in alirocumab group demonstrated a significant reduction of Lp(a) levels, whereas it was not observed in the standard statin group. Notably, greater increases in the percentage changes of CAC score (10.6% [6.3-23.3] vs. 2.9% [-6.7-8.3]; < 0.0001) were observed in the statin group compared to the alirocumab group. Consistently, CAC progression was significantly lower in the alirocumab group than in the standard statin group (0.6 ± 2.2% vs. 2.7 ± 2.3%; = 0.002).

CONCLUSIONS

Study indicated that administration of the PCSK9 inhibitors to statins produced significantly lower rate of CAC progression in patients with coronary artery disease. Further studies with CAC progression and their clinical outcomes are needed.

TRIAL REGISTRATION

ClinicalTrials.gov, Identifier: NCT04851769.

摘要

背景

前蛋白转化酶枯草溶菌素9型(PCSK9)抑制剂已被证明可显著降低低密度脂蛋白胆固醇水平和心血管事件。然而,关于PCSK9抑制剂对冠状动脉钙化影响的证据有限。

方法

将符合条件的中度冠状动脉病变且低密度脂蛋白胆固醇值升高的患者随机分为阿利西尤单抗75mg每2周一次联合他汀类药物(阿托伐他汀20mg/天或瑞舒伐他汀10mg/天)治疗组或标准他汀类药物治疗组。比较基线和随访时基于冠状动脉计算机断层血管造影的钙化积分。

结果

与基线水平相比,两组的低密度脂蛋白胆固醇均显著降低,而接受阿利西尤单抗治疗的患者低密度脂蛋白胆固醇水平的绝对降低幅度更高(1.69±0.52对0.92±0.60,P<0.0001)。此外,阿利西尤单抗组患者的脂蛋白(a)水平显著降低,而标准他汀类药物组未观察到这一现象。值得注意的是,与阿利西尤单抗组相比,他汀类药物组的冠状动脉钙化积分百分比变化增加幅度更大(10.6%[6.3-23.3]对2.9%[-6.7-8.3];P<0.0001)。一致地,阿利西尤单抗组的冠状动脉钙化进展显著低于标准他汀类药物组(0.6±2.2%对2.7±2.3%;P=0.002)。

结论

研究表明,在他汀类药物基础上加用PCSK9抑制剂可使冠心病患者的冠状动脉钙化进展率显著降低。需要进一步研究冠状动脉钙化进展及其临床结局。

试验注册

ClinicalTrials.gov,标识符:NCT04851769。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f19a/9120536/0240e76db25b/fcvm-09-907662-g0001.jpg

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