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
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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, the investigators 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 ≥40 mm (targeted for 1000 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". Absolute expansion criteria indicate minimum stent area (MSA) >4.5mm2 and relative expansion criteria indicate MSA > 80% of average reference lumen area. The patients will receive DES implantation under OCT guidance and stent optimization will be performed to satisfy each expansion criteria.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Combination therapy group Ezetimibe/high-intensity statin combination therapy |
Drug: ezetimibe/high-intensity statin combination therapy (ezetimibe 10mg plus atoravastatin 40mg)
The initial dose of lipid-lowering therapy will be ezetimibe 10mg plus atoravastatin 40mg. During follow-up, the dose of ezetimibe 10mg plus atoravastatin 40mg is strongly recommended to be maintained.
|
| Active Comparator: Statin monotherapy group High-intensity statin monotherapy |
Drug: high-intensity statin monotherapy (atoravastatin 40mg)
The initial dose of lipid-lowering therapy will be atoravastatin 40mg. During follow-up, the dose of atoravastatin 40mg is strongly recommended to be maintained.
|
Outcome Measures
Primary Outcome Measures
- Clinical efficacy of lipid lowering therapy [Within 3 years after the enrollment]
Composite of all-cause death, myocardial infarction (MI), any coronary revascularization, hospitalization for unstable angina, or nonfatal stroke within 3 years
Secondary Outcome Measures
- Proportion of subjects achieving target LDL-cholesterol <55 mg/dL or 70 mg/dL at 6 weeks, 1, 2, and, 3 years [Within 3 years after the enrollment]
- Rate of cross-over into the non-allocated therapy [Within 3 years after the enrollment]
- Each component of primary endpoint A. All-cause death (percentage) [Within 3 years after the enrollment]
- Each component of primary endpoint B. MI (percentage) [Within 3 years after the enrollment]
- Each component of primary endpoint C. Any coronary revascularization (percentage) [Within 3 years after the enrollment]
- Each component of primary endpoint D. Hospitalization for unstable angina (percentage) [Within 3 years after the enrollment]
- Each component of primary endpoint E. Nonfatal-stroke (percentage) [Within 3 years after the enrollment]
- Cardiac death (percentage) [Within 3 years after the enrollment]
- Stent thrombosis (percentage) [Within 3 years after the enrollment]
- Target-vessel revascularization (percentage) [Within 3 years after the enrollment]
- Target-lesion revascularization (percentage) [Within 3 years after the enrollment]
- BARC type 2-5 bleeding (percentage) [Within 3 years after the enrollment]
- BARC type 3-5 bleeding (percentage) [Within 3 years after the enrollment]
- Patient-oriented composite endpoint which is composite of all-cause death, MI, or any coronary revascularization (percentage) [Within 3 years after the enrollment]
- Device-oriented composite endpoint which is composite of cardiovascular death, MI, or clinically-driven target-vessel revascularization (percentage) [Within 3 years after the enrollment]
- Difference in antiplatelet therapy strategy (percentage) [Within 3 years after the enrollment]
- Difference in high-ischemic risks (percentage) [Within 3 years after the enrollment]
- Difference in high-bleeding risks (percentage) [Within 3 years after the enrollment]
- different OCT optimization criteria when treating very long lesions [Within 3 years after the enrollment]
A. Primary endpoint (percentage) B. Stent thrombosis (percentage) C. Target-vessel revascularization (percentage) D. Target-lesion revascularization (percentage) E. Patient-oriented composite endpoint (percentage) F. Device-oriented composite endpoint ((percentage)
- Safety endpoint related to lipid-lowering medication [Within 3 years after the enrollment]
A. New-onset DM, worsening of glycemic control or HOMA-index (percentage) B. Occurrence of SAMS requiring change of therapy regimen or dosage (percentage) C. Elevation of muscle enzymes which is creatine kinase > 4 x Upper Normal Limit (percentage) D. Elevation of hepatic enzymes which is aminotransferase > 3 x Upper Normal Limit (percentage) E. Elevation of serum creatinine level which is > 50% from baseline (percentage) F. Increase of proteinuria (percentage) G. Diagnosis of cancer (percentage)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 19-85 years
-
Patients who underwent coronary revascularization with newer generation DES implantation
Exclusion Criteria:
-
Allergy or hypersensitive to ezetimibe or statin
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Active liver disease or persistent unexplained serum AST/ALT elevation more than 2 times the upper limit of normal range
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History of any adverse drug reaction requiring discontinuation of statin
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Pregnant women, women with potential childbearing, or lactating women
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Life expectancy less than 3 years
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Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
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Inability to understand or read the informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yonsei University Health System, Severance Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Yonsei University
Investigators
- Principal Investigator: Byeong-Keuk Kim, Severance Cardiovascular Hospital, Yonsei University Health System
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4-2022-1335