A Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Segment Elevation Myocardial Infarction The Eindhoven Reperfusion Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 907
- 试验地点
- 1
- 主要终点
- target vessel failure
研究概览
简要总结
The DEBATER study is designed to determine the superiority of abciximab over no abciximab and to determine the superiority of drug eluting stents over bare metal stents in patients with acute myocardial infarction who undergo percutaneous coronary intervention.
详细描述
In patients with acute myocardial infarction primary PCI without prior thrombolytic therapy, is the treatment of choice.
The recommendation for routine stenting in PCI is based on 4 studies that have demonstrated the usefulness of bare metal stents in patients with STEMI. However this recommendation cannot be extrapolated (yet) to the use of drug eluting stents. Although DES have been used widely in unstable angina and in acute myocardial infarction, to date there are no evidence-based recommendations to support the routine use of DES in STEMI.
GPI have been studied extensively in patients with non-STsegment elevation myocardial infarctions (NSTEMI) with planned or performed PCI. In STEMI tirofiban and and eptifibatide are less well investigated, and only abciximab is recommended in primary PCI, but the long term benefits require more investigation. In PCI randomized controlled clinical trials (RCT's) abciximab consistently showed a significant reduction in the rate of myocardial infarction and the need for urgent revascularization. Abciximab has been evaluated in 5 RCT's in association with primary PCI. The pooled analysis for the clinical outcome at 30 days, demonstrate a significant reduction of death, re- infarction and target vessel revascularization (TVR), mainly due to a reduction of repeat intervention. The long-term benefits require more investigation.
The DEBATER trial is designed to answer the questions about the need for abciximab and about the use of DES in primary PCI.
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
- •STEMI ≤ 12 hours (or STEMI equivalent).
- •No contra - indications for primary PCI.
- •No contra - indications for abciximab.
- •Informed consent from the patient.
排除标准
- •Contra - indication for primary PCI: History of peripheral/coronary artery disease that is inaccessible for angiography or PCI.
- •Contra - indications for GPI: Ongoing bleeding, bleeding diathesis, cerebrovascular accident < 6 months, major surgery/trauma < 6 months, platelet count < 100.000 mm3 , intracranial arteriovenous malformation or neoplasm, malignant hypertension, INR >1.5, severe hepatic dysfunction
- •Contra - indications for clopidogrel:
- •Severe liver dysfunction, pathological bleeding disorders such as peptic ulcer or intracranial bleeding.
- •Thrombolytic therapy < 24 hours.
- •Therapy with GPI < 24 hours.
- •Anticoagulation therapy.
- •Co - morbid conditions with a predictable fatal outcome in the short run.
- •No informed consent: refusal, coma, artificial respiration, impaired mentation.
研究组 & 干预措施
Bare metal stent (BMS)
干预措施: bare metal stent prokinetic, chrono, skylor or bluemedical (Device)
Drug eluting stent (DES)
干预措施: drug eluting stent (sirolimus eluting) - CYPHER stent (Device)
Abciximab
干预措施: Abciximab (Drug)
结局指标
主要结局
target vessel failure
时间窗: 30 days and one year
次要结局
- Major adverse cardiac and cerebral adverse events ( MACCE)(30 days and one year)