Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Takeshi Morimoto
- Enrollment
- 3206
- Locations
- 1
- Primary Endpoint
- all-cause death or myocardial infarction
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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
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.
Investigators
Takeshi Morimoto
Professor
Kyoto University, Graduate School of Medicine
Eligibility Criteria
Inclusion Criteria
- •Patients scheduled for percutaneous coronary intervention using drug-eluting stents
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
all-cause death or myocardial infarction
Time Frame: 3-year
target-lesion revascularization
Time Frame: 1-year
Secondary Outcomes
- stent thrombosis (Academic Research Consortium definition)(3-year)
- any repeat coronary revascularization(3-year)
- myocardial infarction(3-year)
- bleeding complications (GUSTO and TIMI definition)(3-year)
- all-cause death(3-year)
- ischemic and hemorrhagic strokes excluding transient ischemic attacks and secondary causes(3-year)
- target-vessel revascularization(3-year)
- cardiac death(3-year)
- clinically-driven target-lesion revascularization(3-year)
- stent deployment success(at implantation)
- procedure time(at implantation)
- non-target-lesion revascularization(3-year)
- coronary artery bypass grafting(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)