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
- Conditions
- Coronary Artery Disease Requiring Coronary Revascularization With Newer Generation DES Implantation
- Interventions
- Drug: ezetimibe/high-intensity statin combination therapy (ezetimibe 10mg plus atoravastatin 40mg)Drug: high-intensity statin monotherapy (atoravastatin 40mg)
- Registration Number
- NCT05782777
- Lead Sponsor
- Yonsei University
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4310
- Age 19-85 years
- Patients who underwent coronary revascularization with newer generation DES implantation
- Allergy or hypersensitive to ezetimibe or statin
- Active liver disease or persistent unexplained serum AST/ALT elevation more than 2 times the upper limit of normal range
- History of any adverse drug reaction requiring discontinuation of statin
- Pregnant women, women with potential childbearing, or lactating women
- Life expectancy less than 3 years
- Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
- Inability to understand or read the informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combination therapy group ezetimibe/high-intensity statin combination therapy (ezetimibe 10mg plus atoravastatin 40mg) Ezetimibe/high-intensity statin combination therapy Statin monotherapy group high-intensity statin monotherapy (atoravastatin 40mg) High-intensity statin monotherapy
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Target-vessel revascularization (percentage) Within 3 years after the enrollment 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 Target-lesion 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 Each component of primary endpoint A. All-cause death (percentage) Within 3 years after the enrollment Difference in high-ischemic 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)
Each component of primary endpoint B. MI (percentage) Within 3 years after the enrollment Stent thrombosis (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 Rate of cross-over into the non-allocated therapy Within 3 years after the enrollment Each component of primary endpoint C. Any coronary revascularization (percentage) Within 3 years after the enrollment Difference in antiplatelet therapy strategy (percentage) Within 3 years after the enrollment Difference in high-bleeding risks (percentage) Within 3 years after the enrollment 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)
Trial Locations
- Locations (1)
Yonsei University Health System, Severance Hospital
🇰🇷Seoul, Korea, Republic of