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

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

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).

Study Overview

• Status: Completed
• Conditions: Multivessel Coronary Artery Disease
• Intervention / Treatment: Procedure: comparison of PCI vs. CABG in multivessel disease

• Study Type: Observational
• Enrollment (Actual): 207

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna, Dept. of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients, treated with multivessel disease requiring revascularization were consecutively included in this study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: September 9, 2010
• First Submitted That Met QC Criteria: September 10, 2010
• First Posted (Estimate): September 13, 2010

Study Record Updates

• Last Update Posted (Estimate): July 18, 2014
• Last Update Submitted That Met QC Criteria: July 16, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: CABG; drug-eluting stent; cost-effectiveness; multivessel coronary artery disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: Version 1