Cost-effectiveness of PCI With Taxus vs CABG - 5 Years FUP

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Multivessel Coronary Artery Disease

Intervention / Treatment
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* Procedure: comparison of PCI vs. CABG in multivessel disease


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCI<br> | Procedure: comparison of PCI vs. CABG in multivessel disease<br>* invasive treatment of coronary artery disease<br>|
| CABG<br> | Procedure: comparison of PCI vs. CABG in multivessel disease<br>* invasive treatment of coronary artery disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease. |  | in-hospital phase (up to 3 weeks) | 
| Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease. |  | 6 months | 
| Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease. |  | 12 months | 
| Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease. |  | 5 years | 
| Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease. |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke |  | 6 months | 
| Rate of target vessel revascularization |  | 6 months | 
| Occurrence of non-fatal acute myocardial infarction |  | 6 months | 
| Occurrence of cardiac death |  | 6 months | 
| Calculation of the total costs |  | in-hospital phase (up to 3 weeks) | 
| Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke |  | 12 months | 
| Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke |  | 5 years | 
| Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke |  | 10 years | 
| Rate of target vessel revascularization |  | 12 months | 
| Rate of target vessel revascularization |  | 5 years | 
| Rate of target vessel revascularization |  | 10 years | 
| Occurrence of non-fatal acute myocardial infarction |  | 12 months | 
| Occurrence of non-fatal acute myocardial infarction |  | 5 years | 
| Occurrence of non-fatal acute myocardial infarction |  | 10 years | 
| Occurrence of cardiac death |  | 12 months | 
| Occurrence of cardiac death |  | 5 years | 
| Occurrence of cardiac death |  | 10 years | 
| Calculation of the total costs |  | 6 months | 
| Calculation of the total costs |  | 12 months | 
| Calculation of the total costs |  | 5 years | 
| Calculation of the total costs |  | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multivessel coronary artery disease, drug-eluting stent, CABG, cost-effectiveness