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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,206
Everolimus-eluting stent
Sirolimus-eluting stent
Division of Cardiology, Kyoto University Hospital
Kyoto, Kyoto, Japan
target-lesion revascularization
Time frame: 1-year
all-cause death or myocardial infarction
Time frame: 3-year
all-cause death
Time frame: 3-year
cardiac death
Time frame: 3-year
myocardial infarction
Time frame: 3-year
stent thrombosis (Academic Research Consortium definition)
Time frame: 3-year
ischemic and hemorrhagic strokes excluding transient ischemic attacks and secondary causes
Time frame: 3-year
bleeding complications (GUSTO and TIMI definition)
Time frame: 3-year
stent deployment success
Time frame: at implantation
procedure time
Time frame: at implantation
clinically-driven target-lesion revascularization
Time frame: 3-year
non-target-lesion revascularization
Time frame: 3-year
coronary artery bypass grafting
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Time frame: 3-year
target-vessel revascularization
Time frame: 3-year
any repeat coronary revascularization
Time frame: 3-year
composite of cardiac death, myocardial infarction in the territory of the target vessel or target-lesion revascularization
Time frame: 3-year
composite of all-cause death, any myocardial infarction or any repeat coronary revascularization
Time frame: 3-year