依折麦布与阿托伐他汀联用对比单用阿托伐他汀对经皮冠状动脉介入治疗后短期主要不良心脏事件影响的双盲安慰剂对照随机临床试验
Comparison of ezetimibe and atorvastatin versus atorvastatin alone on short-term major adverse cardiac events after percutaneous coronary intervention, a double-blind placebo-controlled randomized clinical trial.
作者信息
Farshidi Hossein, Bijani Badri, Sobhani Seyed Alireza, Dastsouz Farideh, Abbaszadeh Shahin
机构信息
Cardiovascular Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran.
出版信息
Trials. 2025 Mar 28;26(1):108. doi: 10.1186/s13063-025-08817-7.
BACKGROUND
Major cardiovascular events (MACE) after percutaneous coronary intervention (PCI) are among the most common causes of death in patients. Lipid-lowering strategies seem to affect these events. Reaching the best regimen for controlling lipid abnormalities is important. This study aimed to compare the effect of ezetimibe and atorvastatin versus atorvastatin alone in short-term major cardiovascular events in patients after PCI in Bandar Abbas in 2018.
METHODS
This double-blinded randomized controlled trial was done in Bandar Abbas in 2018 on 224 patients. Patients were randomly divided into two groups either to receive ezetimibe and atorvastatin (group A) or atorvastatin alone (group B). Patients were followed for 1 month for major cardiovascular events and drug side effects. Data was analyzed using SPSS software.
RESULTS
Patients in the two groups had similar baseline characteristics. The mean low-density lipoproteins (LDL) level was 69.83 ± 28.8 in group A and 82.45 ± 29.9 in group B (P = 0.014). At the end of the study, high-sensitivity C-reactive protein (hs-CRP) values were notably lower in group A (P value = 0.005). Three (2.7%) patients in group A and 1 patient (0.9%) in group B had a myocardial infarction (P value = 0.313). Also, 11 patients (9.8%) in group A and 13 patients (11.6%) in group B had unstable angina (P value = 0.666). No patients had death, cerebrovascular event, or stent thrombosis in the two groups.
CONCLUSION
Although adding ezetimibe to atorvastatin can decrease LDL and hs-CRP levels in short-term follow-up; it is not effective in lowering short-term major cardiovascular events in patients after PCI. Studies with longer-term follow-up are recommended.
TRIAL REGISTRATION
IRCT, IRCT20171028037047N1. Registered on 22 June 2018, https://irct.behdasht.gov.ir/trial/28808 .
背景
经皮冠状动脉介入治疗（PCI）后发生的主要心血管事件（MACE）是患者最常见的死亡原因之一。降脂策略似乎会影响这些事件。达成控制脂质异常的最佳方案很重要。本研究旨在比较依折麦布与阿托伐他汀联合用药和单独使用阿托伐他汀对2018年阿巴斯港PCI术后患者短期主要心血管事件的影响。
方法
2018年在阿巴斯港对224例患者进行了这项双盲随机对照试验。患者被随机分为两组，分别接受依折麦布与阿托伐他汀联合治疗（A组）或单独使用阿托伐他汀（B组）。对患者进行为期1个月的主要心血管事件和药物副作用随访。使用SPSS软件分析数据。
结果
两组患者的基线特征相似。A组的平均低密度脂蛋白（LDL）水平为69.83±28.8，B组为82.45±29.9（P = 0.014）。研究结束时，A组的高敏C反应蛋白（hs-CRP）值显著较低（P值 = 0.005）。A组有3例（2.7%）患者发生心肌梗死，B组有1例（0.9%）患者发生心肌梗死（P值 = 0.313）。此外，A组有11例（9.8%）患者发生不稳定型心绞痛，B组有13例（11.6%）患者发生不稳定型心绞痛（P值 = 0.666）。两组均无患者死亡、发生脑血管事件或支架血栓形成。
结论
虽然在阿托伐他汀基础上加用依折麦布可在短期随访中降低LDL和hs-CRP水平；但对降低PCI术后患者的短期主要心血管事件无效。建议进行长期随访研究。
试验注册
IRCT，IRCT20171028037047N1。于2018年6月22日注册，https://irct.behdasht.gov.ir/trial/28808 。
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