Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,206
- 试验地点
- 2
- 主要终点
- all-cause death or myocardial infarction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for percutaneous coronary intervention using drug-eluting stents
排除标准
- 未提供
结局指标
主要结局
all-cause death or myocardial infarction
时间窗: 3-year
target-lesion revascularization
时间窗: 1-year
次要结局
- 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)
研究者
Takeshi Morimoto
Professor
Kyoto University, Graduate School of Medicine