Effect of High-intensity Statin With Ezetimibe COmbination theRapy Versus High-intensity sTatin Monotherapy After Percutaneous Coronary Intervention With Drug-eluting Stents; the ESCORT Trial

Yonsei University

Status: Enrolling

Conditions: Coronary Artery Disease Requiring Coronary Revascularization With Newer Generation DES Implantation

Treatments: Drug: ezetimibe/high-intensity statin combination therapy (ezetimibe 10mg plus atoravastatin 40mg); Drug: high-intensity statin monotherapy (atoravastatin 40mg)

Study type: Interventional

Funder types: Other

Identifiers

NCT05782777

4-2022-1335

Details and patient eligibility

About

This study sought to evaluate whether ezetimibe combination to high-intensity statin therapy will have more prominent beneficial effect compared to high-intensity statin monotherapy in patients who underwent coronary revascularization with newer generation drug-eluting stent (DES) implantation. Furthermore, the optimal OCT-based optimal expansion criteria as well as the efficacy and safety of newer generation will be investigated.

Full description

All eligible patients who underwent coronary revascularization with newer generation DES implantation will be enrolled according to inclusion/exclusion criteria after voluntary agreement with informed consent. At the time of enrollment, we will stratify the patients according to LDL-cholesterol <100mg/dL, acute coronary syndrome, and DES type, and randomly assign them in two groups according to lipid-lowering therapy with a 1:1 ratio: "Combination therapy group" vs. "Statin monotherapy group". In this study, four types of new generation DES will be used: Orsiro (Biotronik), Firehawk (Microport), Genoss (Genoss) or D+Storm (CGBIO).

In this study, OCT substudy will be performed for the patients with diffuse long lesions requiring total stented length ≥30 mm (targeted for 700 patients in the trial). Corresponding patients will be randomly assigned into two groups according to the OCT-based optimal expansion criteria with a 1:1 ratio: meeting "Absolute expansion" vs. "Relative expansion". The absolute expansion criteria is defined as a minimum stent area (MSA) >4.5mm2, while the relative expansion criteria is defined as achieving an MSA ≥ 80% of the mean reference lumen area or ≥ 100% of the distal reference lumen area. The patients will receive DES implantation under OCT guidance and stent optimization will be performed to satisfy the assigned expansion criteria.

Enrollment: 4,310 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 19-85 years
2. Patients who underwent coronary revascularization with newer generation DES implantation

Exclusion criteria

1. Allergy or hypersensitive to ezetimibe or statin
2. Active liver disease or persistent unexplained serum AST/ALT elevation more than 2 times the upper limit of normal range
3. History of any adverse drug reaction requiring discontinuation of statin
4. Pregnant women, women with potential childbearing, or lactating women
5. Life expectancy less than 3 years
6. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
7. Inability to understand or read the informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,310 participants in 2 patient groups

Combination therapy group

Experimental group

Description:

Ezetimibe/high-intensity statin combination therapy

Treatment:

Drug: ezetimibe/high-intensity statin combination therapy (ezetimibe 10mg plus atoravastatin 40mg)

Statin monotherapy group

Active Comparator group

Description:

High-intensity statin monotherapy

Treatment:

Drug: high-intensity statin monotherapy (atoravastatin 40mg)