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

Multivessel Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199419
• Other study ID #: Version 1
• Status: Completed
• Phase: N/A
• First received: September 9, 2010
• Last updated: July 16, 2014
• Start date: January 2004
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Multivessel Coronary Artery Disease
• Myocardial Ischemia

Intervention

Procedure:
• comparison of PCI vs. CABG in multivessel disease
invasive treatment of coronary artery disease

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Dept. of Cardiology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Primary	Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.		6 months	Yes
Primary	Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.		12 months	Yes
Primary	Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.		5 years	Yes
Primary	Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.		10 years	Yes
Secondary	Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke		6 months	Yes
Secondary	Rate of target vessel revascularization		6 months	Yes
Secondary	Occurrence of non-fatal acute myocardial infarction		6 months	Yes
Secondary	Occurrence of cardiac death		6 months	Yes
Secondary	Calculation of the total costs		in-hospital phase (up to 3 weeks)	Yes
Secondary	Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke		12 months	Yes
Secondary	Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke		5 years	Yes
Secondary	Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke		10 years	Yes
Secondary	Rate of target vessel revascularization		12 months	Yes
Secondary	Rate of target vessel revascularization		5 years	Yes
Secondary	Rate of target vessel revascularization		10 years	Yes
Secondary	Occurrence of non-fatal acute myocardial infarction		12 months	Yes
Secondary	Occurrence of non-fatal acute myocardial infarction		5 years	Yes
Secondary	Occurrence of non-fatal acute myocardial infarction		10 years	Yes
Secondary	Occurrence of cardiac death		12 months	Yes
Secondary	Occurrence of cardiac death		5 years	Yes
Secondary	Occurrence of cardiac death		10 years	Yes
Secondary	Calculation of the total costs		6 months	Yes
Secondary	Calculation of the total costs		12 months	Yes
Secondary	Calculation of the total costs		5 years	Yes
Secondary	Calculation of the total costs		10 years	Yes