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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT01199419

Collaborator

(none)

207

Enrollment

Location

126

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Multivessel Coronary Artery Disease	Procedure: comparison of PCI vs. CABG in multivessel disease

Study Design

Study Type:

Observational

Actual Enrollment :

207 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2004

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
PCI	Procedure: comparison of PCI vs. CABG in multivessel disease invasive treatment of coronary artery disease
CABG	Procedure: comparison of PCI vs. CABG in multivessel disease invasive treatment of coronary artery disease

Arm

Intervention/Treatment

PCI

Procedure: comparison of PCI vs. CABG in multivessel disease

invasive treatment of coronary artery disease

CABG

Procedure: comparison of PCI vs. CABG in multivessel disease

invasive treatment of coronary artery disease

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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