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

Abstract 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 a...

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Main Authors: Hossein Farshidi, Badri Bijani, Seyed Alireza Sobhani, Farideh Dastsouz, Shahin Abbaszadeh
Format: Article
Language:English
Published: BMC 2025-03-01
Series:Trials
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Online Access:https://doi.org/10.1186/s13063-025-08817-7
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author Hossein Farshidi
Badri Bijani
Seyed Alireza Sobhani
Farideh Dastsouz
Shahin Abbaszadeh
author_facet Hossein Farshidi
Badri Bijani
Seyed Alireza Sobhani
Farideh Dastsouz
Shahin Abbaszadeh
author_sort Hossein Farshidi
collection DOAJ
description Abstract 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 .
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spelling doaj-art-3d752c1f96d940bf949e42ce12aa27ae2025-08-20T03:40:44ZengBMCTrials1745-62152025-03-012611610.1186/s13063-025-08817-7Comparison 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 trialHossein Farshidi0Badri Bijani1Seyed Alireza Sobhani2Farideh Dastsouz3Shahin Abbaszadeh4Cardiovascular Research Center, Hormozgan University of Medical SciencesCardiovascular Research Center, Hormozgan University of Medical SciencesDepartment of Pathology, School of Medicine, Hormozgan University of Medical SciencesCardiovascular Research Center, Hormozgan University of Medical SciencesCardiovascular Research Center, Hormozgan University of Medical SciencesAbstract 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 .https://doi.org/10.1186/s13063-025-08817-7EzetimibeAtorvastatinMajor adverse cardiovascular eventsCoronary intervention
spellingShingle Hossein Farshidi
Badri Bijani
Seyed Alireza Sobhani
Farideh Dastsouz
Shahin Abbaszadeh
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
Trials
Ezetimibe
Atorvastatin
Major adverse cardiovascular events
Coronary intervention
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Ezetimibe
Atorvastatin
Major adverse cardiovascular events
Coronary intervention
url https://doi.org/10.1186/s13063-025-08817-7
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