Cost-effectiveness of Percutaneous Coronary Intervention With TAXUS Stents in Patients With Multivessel Coronary Artery Disease Compared With Aortocoronary Bypass Surgery 5 Years After Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.
研究概览
简要总结
The objective of the present study is to analyze the cost-effectiveness of percutaneous coronary intervention (PCI) using TAXUS stents compared to the costs of coronary artery bypass surgery (CABG) in patients with multivessel coronary artery disease (CAD) in the first 5 years and then 10 years after intervention. Multivessel PCI or CABG was performed in 114 or 93 patients, respectively. Clinical outcomes, in terms of incidence of acute myocardial infarction (AMI), all-cause death, target vessel revascularization (TVR) and stroke, resource use and costs are analyzed prospectively over a 5 and 10-year follow-up (FUP) period. Overall costs consist of the baseline costs of the index procedure (PCI or CABG), clinical and angiographic procedure-related treatments during the entire FUP. The primary endpoint is cost-effectiveness and clinical effectiveness, defined as the reduction of the composite of major adverse cardiac and cerebrovascular events (MACCE).
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
- •two or three-vessel disease requiring percutaneous or surgical multivessel intervention with the aim of complete revascularization
- •age > 18 years
- •clinical symptoms (stable or unstable angina) or signs of myocardial ischemia
- •≥ 50% diameter stenosis of each lesion
排除标准
- •acute myocardial infarction (< 48 h);
- •contraindications to clopidogrel, aspirin, heparin and taxol;
- •pregnancy or lack of protection against pregnancy or breast-feeding during the study;
- •hemorrhagic diathesis and platelet count <100.000/ml3
结局指标
主要结局
Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.
时间窗: 10 years
次要结局
- Occurrence of cardiac death(10 years)
- Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke(10 years)
- Rate of target vessel revascularization(10 years)
- Occurrence of non-fatal acute myocardial infarction(10 years)
- Calculation of the total costs(10 years)
研究者
Mariann Gyongyosi
MD PhD
Medical University of Vienna