NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Everolimus-eluting stentDevice: Biolimus-eluting stent
- Registration Number
- NCT01303640
- Lead Sponsor
- Takeshi Morimoto
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3235
- Patients scheduled for percutaneous coronary intervention using drug-eluting stents
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Everolimus-eluting stent Everolimus-eluting stent Everolimus-eluting stent Biolimus-eluting stent Biolimus-eluting stent Biolimus-eluting stent
- Primary Outcome Measures
Name Time Method target-lesion revascularization 1-year target-lesion revascularization
death or myocardial infarction at 3-year after stent implantation 3-year death or myocardial infarction at 3-year after stent implantation
- Secondary Outcome Measures
Name Time Method composite of all-cause death, acute myocardial infarction or any repeat coronary revascularization 3-year composite of all-cause death, acute myocardial infarction or any repeat coronary revascularization
cardiac death 3-year death due to cardiac origins
acute myocardial infarction 3-year acute myocardial infarction
stent thrombosis 3-year stent thrombosis defined by Academic Reseach Consortium definition
all-cause death 3-year death due to any cause
stroke 3-year stroke excluding transient ischemic attacks
bleeding complications 3-year bleeding complications defined by GUSTO and TIMI definitions
success rate for stent deployment 3-year success rate for stent deployment
procedure time 3-year procedure time
clinically-driven target-lesion revascularization 3-year clinically-driven target-lesion revascularization
non-target-lesion revascularization 3-year non-target-lesion revascularization
coronary artery bypass grafting 3-year coronary artery bypass grafting
target-vessel revascularization 3-year target-vessel revascularization
any repeat coronary revascularization 3-year any repeat coronary revascularization
composite of cardiac death, acute myocardial infarction in the territory of the target vessel or target-lesion revascularization 3-year composite of cardiac death, acute myocardial infarction in the territory of the target vessel or target-lesion revascularization
Trial Locations
- Locations (1)
Department of Cardiovascular Medicine, Kyoto University Hospital
🇯🇵Kyoto, Japan