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Plaque REgression with Cholesterol absorption Inhibitor or Synthesis inhibitor Evaluated by IntraVascular UltraSound
Kenichi Tsujita1, Seigo Sugiyama2, Hitoshi Sumida3
1Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
Insights
The PRECISE-IVUS trial investigates if adding ezetimibe to atorvastatin reduces coronary plaque more than atorvastatin alone. This dual therapy aims to improve outcomes for patients with coronary artery disease (CAD).
Area of Science:
- Cardiology
- Pharmacology
- Medical Imaging
Background:
- High residual risk of cardiovascular events persists in many patients despite statin therapy for lowering low-density lipoprotein cholesterol (LDL-C).
- Combination therapy with ezetimibe and statins demonstrates superior LDL-C reduction compared to statin monotherapy.
Purpose of the Study:
- The Plaque REgression with Cholesterol absorption Inhibitor or Synthesis inhibitor Evaluated by IntraVascular UltraSound (PRECISE-IVUS) trial evaluates the impact of adding ezetimibe to atorvastatin versus atorvastatin monotherapy.
- The study assesses effects on coronary plaque regression and lipid profile changes in patients with coronary artery disease (CAD).
Main Methods:
- A prospective, randomized, controlled, multicenter study involving patients undergoing IVUS-guided percutaneous coronary intervention.
- Patients were randomized to receive either atorvastatin alone or atorvastatin plus ezetimibe (10 mg daily).
- Intravascular ultrasound (IVUS) was used for baseline and 9-12 month follow-up assessments of coronary atheroma volume.
Main Results:
- The primary endpoint is the change in percent coronary atheroma volume as measured by volumetric IVUS analysis.
- The study aims to determine if the combination therapy is non-inferior to monotherapy in reducing coronary plaque.
- Lipid profiles were monitored throughout the study.
Conclusions:
- The PRECISE-IVUS trial will determine if ezetimibe/atorvastatin combination therapy is non-inferior to atorvastatin monotherapy for coronary plaque reduction.
- The study will assess if this dual lipid-lowering strategy translates to increased clinical benefit in a Japanese population.
Background:
Although the positive association between achieved low-density lipoprotein cholesterol (LDL-C) level and the risk of coronary artery disease (CAD) has been confirmed by randomized studies with statins, many patients remain at high residual risk of events suggesting the necessity of novel pharmacologic strategies. The combination of ezetimibe/statin produces greater reductions in LDL-C compared to statin monotherapy.
Purpose:
The Plaque REgression with Cholesterol absorption Inhibitor or Synthesis inhibitor Evaluated by IntraVascular UltraSound (PRECISE-IVUS) trial was aimed at evaluating the effects of ezetimibe addition to atorvastatin, compared with atorvastatin monotherapy, on coronary plaque regression and change in lipid profile in patients with CAD.
Methods:
The study is a prospective, randomized, controlled, multicenter study. The eligible patients undergoing IVUS-guided percutaneous coronary intervention will be randomly assigned to receive either atorvastatin alone or atorvastatin plus ezetimibe (10 mg) daily using a web-based randomization software. The dosage of atorvastatin will be increased by titration within the usual dose range with a treatment goal of lowering LDL-C below 70 mg/dL based on consecutive measures of LDL-C at follow-up visits. IVUS will be performed at baseline and 9-12 months follow-up time point at participating cardiovascular centers. The primary endpoint will be the nominal change in percent coronary atheroma volume measured by volumetric IVUS analysis.
Conclusion:
PRECISE-IVUS will assess whether the efficacy of combination of ezetimibe/atorvastatin is noninferior to atorvastatin monotherapy for coronary plaque reduction, and will translate into increased clinical benefit of dual lipid-lowering strategy in a Japanese population.
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