Comparison of the Long-term Effects on Mortality and Cardiovascular Morbidity of Percutaneous Coronary Intervention With Drug-eluting Stent Versus Bare-metal Stent. Randomized, Five-year Prospective, Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9,013
- 试验地点
- 16
- 主要终点
- First occurrence of all-cause mortality and non-fatal myocardial infarction (composite)
研究概览
简要总结
Stenosis of the coronary arteries may be treated by balloon dilatation followed by the implantation of a metal stent. However, restenosis occurs in 10-20% of patients treated with bare metal stents (BMS). Restenosis and treatment of restenosis is associated with risk of myocardial infarction (MI) and death. Drug eluting stents (DES)release drugs to the vessel wall that delay or inhibit the process of restenosis. Some reports have found that DES are associated with risk of acute stent thrombosis, MI and death. The precise magnitude of this risk is not known. Current evidence is therefore insufficient to balance the long-term risk and benefit of BMS vs DES.
The purpose of this trial is to compare the long-term effects on MI and total mortality of BMS vs DES. The trial will recruit 8000 patients from 8 Norwegian hospitals. The patients will be randomized to treatment with BMS or DES. Clinical events will be registered for 5 years after treatment. The study hypothesis is that there is no difference in the risk of death or myocardial infarction after treatment with BMS vs DES. The trial is initiated and run by university researchers and is sponsored by not-for-profit organizations.
详细描述
Background:
The balance of the long-term risks and benefits of coronary drug-eluting stents versus bare metal stents is not known.
Study objective:
The primary objective of the trial is to compare in a real-world setting the long-term effects on the incidence of death and myocardial infarction (composite primary end-point) after implantation of drug-eluting stents versus bare-metal stents. The secondary objective is to compare the long-term effects on the incidence of total death, cardiovascular deaths, major cardiovascular events, angina pectoris, revascularization procedures, and on health-related quality of life after implantation of drug-eluting stents versus bare-metal stents. The main tertiary objective is to assess the safety and efficacy in patient subgroups with specific demographic, clinical, and vessel- or lesion characteristics, and to conduct a cost-effectiveness analysis.
Study design:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women >18 years with stable angina pectoris or acute coronary syndrome
- •The patient has consented to participate and has signed the patient informed consent form
- •All lesions requiring intervention in one or more native coronary artery/coronary artery by-pass graft are amendable for implantation of drug-eluting stents only, or bare-metal stents only.
- •The patient has a unique 11-digit Norwegian person number, is able to communicate in Norwegian, and is expected not to emigrate during study follow-up.
排除标准
- •Previous implantation of a coronary bare metal stent or coronary drug eluting stent
- •Planned intervention of a bifurcation lesion with overlapping 2-stent technique
- •The patient has a serious medical condition (other than coronary artery disease) with a life expectancy less than 5 years
- •The patient is currently participating in another randomized trial that clinically interferes with the present trial, or requires coronary angiography or other coronary artery imaging procedures
- •Hypersensitivity or allergies to drugs or components in use with percutaneous coronary intervention
- •Contraindications for treatment with clopidogrel/ticlid for 9-12 months
- •Patient is receiving chronic anticoagulation therapy (e.g., warfarin, heparin)
研究组 & 干预措施
Bare metal stent
Implantation of one or more bare metal stent(s) to to treat coronary artery stenosis
干预措施: Percutaneous coronary intervention (PCI) (Device)
Drug eluting stent
Implantation of one or more drug eluting stent(s) to treat coronary artery stenosis
干预措施: Percutaneous coronary intervention (PCI) (Device)
结局指标
主要结局
First occurrence of all-cause mortality and non-fatal myocardial infarction (composite)
时间窗: After five years of follow-up
次要结局
- Major cardiovascular events(After five years of follow-up)
- Health related quality of life(After 6 months and then yearly for 5 years)