NOBORI Biolimus-Eluting Versus XIENCE/PROMUS 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 biolimus-eluting stent is not inferior to the everolimus-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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Everolimus-eluting stent is the most widely used coronary drug-eluting stent in Japan. Biolimus-eluting stent is a new coronary drug-eluting stent, which is going to be approved in 2011 by the Japanese Ministry of Health, Labor and Welfare. It has been reported that biolimus-eluting stent had lower rate of target-lesion revascularization and stent thrombosis at 9 months as compared with paclitaxel-eluting stent. However, trial results comparing biolimus-eluting stent with everolimus-eluting stent are largely unknown. The purpose of this study is to evaluate whether the newly-approved biolimus-eluting stent is not inferior to the everolimus-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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NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Biolimus-eluting stent
* Device: Everolimus-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
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 |
| --- | --- |
| Active Comparator: Biolimus-eluting stent<br>Biolimus-eluting stent | Device: Biolimus-eluting stent<br>* Biolimus-eluting stent<br>|
| Active Comparator: Everolimus-eluting stent<br>Everolimus-eluting stent | Device: Everolimus-eluting stent<br>* Everolimus-eluting stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target-lesion revascularization | target-lesion revascularization | 1-year | 
| death or myocardial infarction at 3-year after stent implantation | death or myocardial infarction at 3-year after stent implantation | 3-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause death | death due to any cause | 3-year | 
| cardiac death | death due to cardiac origins | 3-year | 
| acute myocardial infarction | acute myocardial infarction | 3-year | 
| stent thrombosis | stent thrombosis defined by Academic Reseach Consortium definition | 3-year | 
| stroke | stroke excluding transient ischemic attacks | 3-year | 
| bleeding complications | bleeding complications defined by GUSTO and TIMI definitions | 3-year | 
| success rate for stent deployment | success rate for stent deployment | 3-year | 
| procedure time | procedure time | 3-year | 
| clinically-driven target-lesion revascularization | clinically-driven target-lesion revascularization | 3-year | 
| non-target-lesion revascularization | non-target-lesion revascularization | 3-year | 
| coronary artery bypass grafting | coronary artery bypass grafting | 3-year | 
| target-vessel revascularization | target-vessel revascularization | 3-year | 
| any repeat coronary revascularization | any repeat coronary revascularization | 3-year | 
| composite of cardiac death, acute myocardial infarction in the territory of the target vessel or target-lesion revascularization | composite of cardiac death, acute myocardial infarction in the territory of the target vessel or target-lesion revascularization | 3-year | 
| composite of all-cause death, acute myocardial infarction or any repeat coronary revascularization | composite of all-cause death, acute 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