Ten-year Follow-up of the Clinical Evaluation of Everolimus-Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction: EXAMINATION-EXTEND Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,498
- 试验地点
- 11
- 主要终点
- Patient-oriented Composite Endpoint (PoCE)
研究概览
简要总结
The EXAMINATION trial was a superiority trial that compared everolimus-eluting stents (EES) versus bare-metal stents (BMS) in an all-comer ST-segment elevation myocardial infarction (STEMI) population. The patient-oriented endpoint was not superior at 1-year, but it was at 5-year. However, very-long term follow-up is unknown. The study had an independent Clinical event Committee (CEC). All events were adjudicated by an independent clinical committee, according to the Academic Research Consortium 1.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were enrolled in the EXAMINATION trial (NCT00828087).
排除标准
- 未提供
研究组 & 干预措施
Everolimus Arm
Everolimus Eluting Coronary Stent System
干预措施: Everolimus Eluting Coronary Stent System (Drug)
Non-drug eluting stent Arm
Cobalt chromium balloon-expandable stent
干预措施: Cobalt chromium balloon expandable stent (non-drug-eluting stent Arm) (Device)
结局指标
主要结局
Patient-oriented Composite Endpoint (PoCE)
时间窗: 10 years
Rate of composite endpoint of all-cause death, any myocardial infarction, and any revascularization. Defined according to the Academic Research Consortium 1.
次要结局
- Rate of all cause and cardiac mortality(10 years)
- Rate of target lesion revascularization(10 years)
- Rate of stent thrombosis(10 years)
- Device-oriented Composite Endpoint (DoCE)(10 years)
- Rate of recurrent myocardial infarction(10 years)