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

Medical University of Vienna

Status: Completed

Conditions: Multivessel Coronary Artery Disease

Treatments: Procedure: comparison of PCI vs. CABG in multivessel disease

Study type: Observational

Funder types: Other

Identifiers

NCT01199419

Version 1

Details and patient eligibility

About

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).

Enrollment: 207 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

207 participants in 2 patient groups

PCI

Treatment:

Procedure: comparison of PCI vs. CABG in multivessel disease

CABG

Treatment:

Procedure: comparison of PCI vs. CABG in multivessel disease