Coronary Artery Disease
Conditions
Keywords
Coronary stent
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.
Interventions
DEVICEBiolimus-eluting stent
Biolimus-eluting stent
DEVICEEverolimus-eluting stent
Everolimus-eluting stent
Sponsors
Takeshi Morimoto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for percutaneous coronary intervention using drug-eluting stents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| acute myocardial infarction | 3-year | acute myocardial infarction |
| stent thrombosis | 3-year | stent thrombosis defined by Academic Reseach Consortium definition |
| 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 |
| all-cause death | 3-year | death due to any cause |
| 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 |
| 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 |
| clinically-driven target-lesion revascularization | 3-year | clinically-driven target-lesion revascularization |
| cardiac death | 3-year | death due to cardiac origins |
Countries
Japan
Outcome results
None listed