Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether the newly-approved everolimus-eluting stent is not inferior to the sirolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice.

Detailed Description
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Sirolimus-eluting stent is the most widely used coronary drug-eluting stent in Japan. Everolimus-eluting stent is a new coronary drug-eluting stent, which is going to be approved in the first quarter of 2010 by the Japanese Ministry of Health, Labor and Welfare. It has recently been reported that everolimus-eluting stent had lower rate of target-lesion revascularization and stent thrombosis at 1 year as compared with paclitaxel-eluting stent. However, trial results comparing everolimus-eluting stent with sirolimus-eluting stent are largely unknown. The purpose of this study is to evaluate whether the newly-approved everolimus-eluting stent is not inferior to the sirolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice. The design of this study is all-comer design enrolling patients scheduled for percutaneous coronary intervention using drug-eluting stents without any exclusion criteria.

Official Title
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Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Everolimus-eluting stent
* Device: Sirolimus-eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for percutaneous coronary intervention using drug-eluting stents Exclusion Criteria: None
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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Everolimus-eluting stent<br> | Device: Everolimus-eluting stent<br>* Everolimus-eluting stent<br>|
| Active Comparator: Sirolimus-eluting stent<br> | Device: Sirolimus-eluting stent<br>* Sirolimus-eluting stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target-lesion revascularization |  | 1-year | 
| all-cause death or myocardial infarction |  | 3-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause death |  | 3-year | 
| cardiac death |  | 3-year | 
| myocardial infarction |  | 3-year | 
| stent thrombosis (Academic Research Consortium definition) |  | 3-year | 
| ischemic and hemorrhagic strokes excluding transient ischemic attacks and secondary causes |  | 3-year | 
| bleeding complications (GUSTO and TIMI definition) |  | 3-year | 
| stent deployment success |  | at implantation | 
| procedure time |  | at implantation | 
| clinically-driven target-lesion revascularization |  | 3-year | 
| non-target-lesion revascularization |  | 3-year | 
| coronary artery bypass grafting |  | 3-year | 
| target-vessel revascularization |  | 3-year | 
| any repeat coronary revascularization |  | 3-year | 
| composite of cardiac death, myocardial infarction in the territory of the target vessel or target-lesion revascularization |  | 3-year | 
| composite of all-cause death, any myocardial infarction or any repeat coronary revascularization |  | 3-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary stent