Rosuvastatin and Evolocumab for Coronary Artery Disease

Study Overview
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Brief Summary
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The aim of the retrospective study is to characterize the molecular mechanisms responsible for the effect of statins and evolocumab in patients with stable coronary artery disease. The research team will retrieve and review intravascular imaging and gene expression data previously collected in the catheterization laboratory during the following time-period: 8/1/2013-4/14/2015 and 5/4/2021 - 10/28/2022.

Detailed Description
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The researchers will use the previously collected transcriptomic and intravascular imaging data collected from subjects between 8/1/2013-4/14/2015 (statin group) and subjects who participated in YELLOW III study (evolocumab group). The analyses will allow us detect common and unique pathways for each drug. The researchers will use intravascular imaging findings (optical coherence tomography, OCT) to characterize patient's individual response to treatment as beneficial, if OCT fibrous cap thickness (FCT) increased at follow-up and develop machine-learning models to predict the individual response using baseline gene expression. The researchers hypothesize that the analyses will uncover unique gene panels predicting beneficial response to statin and evolocumab allowing to select the best treatment approach for an individual patient. The total number of subjects will be 195. Transcriptomic profile of PBMC at baseline and follow-up will be compared between the groups to establish the common and distinctive molecular mechanisms of the effect of statins and evolocumab.

Official Title
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Effect of Statins and Evolocumab on Peripheral Blood Mononuclear Cell Gene Expression in Patients With Coronary Artery Disease: Yellow V

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: statin
* Drug: evolocumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with coronary artery disease who underwent cardiac catheterization with or without PCI Patients from 8/1/2013-4/14/2015 and YELLOW III with both visits available, baseline and follow-up Exclusion Criteria: patients from 8/1/2013-4/14/2015 and YELLOW III lost to follow-up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Statin<br>85 patients treated with statin | Drug: statin<br>* 40 mg of rosuvastatin daily for 8-12 weeks<br>|
| Evolocumab<br>110 patients treated with evolocumab in addition to statin or evolocumab alone | Drug: statin<br>* 40 mg of rosuvastatin daily for 8-12 weeks<br>Drug: evolocumab<br>* 140 mg evolocumab every 2 weeks (26 weeks)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression levels of mRNA in blood cells | Expression levels of mRNA in blood cells of the patients to be measured to identify the genes which are associated with a beneficial response to treatment using transcriptomic analysis of PBMC to find the key genes (biomarkers) responsible for effective therapy. | 18 month |