Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With ST Elevation Myocardial Infarction (STEMI) (RaCES-MI Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- cardiac death, reinfarction and Target Vessel Revascularization (TVR)
研究概览
简要总结
Randomized trial to test the efficacy and safety of newer Drug Eluting Stent generation in patient with acute myocardial infarction treated with primary percutaneous coronary intervention (PCI)
详细描述
The efficacy and safety of drug-eluting stents (DES) in the treatment of coronary artery disease is well established. It is well known that Drug Eluting Stent (DES) have dramatically decreased Restenosis rates for both on-label and off-label indications. However, the concern for increased (late) stent thrombosis is still present DES implantation in patient with acute myocardial infarction is still controversial because acute coronary lesion presents the highest possible thrombotic burden Newer DES with new antiproliferative drugs and more biocompatible polymers have shown a significant reduction of (late) stent thrombosis in patients in stable condition.
Aim of the study was to asses the long term efficacy and safety on second generation everolimus eluting stent compared with first generation sirolimus eluting stent
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
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All ST segment elevation myocardial infarction (STEMI) patients eligible for primary PCI
排除标准
- •Contraindication to dual antiplatelet therapy for 12 months
- •Known allergy to sirolimus or everolimus
- •Major surgical procedure planned within 1 month.
- •History, symptoms, or findings suggestive of aortic dissection.
- •Participation in other trials
结局指标
主要结局
cardiac death, reinfarction and Target Vessel Revascularization (TVR)
时间窗: 36 MONTHS
Any death of cardiac origin, any myocardial infarction and any new revascularization of the infarct related artery
次要结局
- cardiac death, reinfarction, Target Vessel Revascularization (TVR) and definite/probable stent thrombosis(36 months)
研究者
Emilio Di Lorenzo MD PhD
Chief Interventional Cardiology
San Giuseppe Moscati Hospital