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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01199419
Enrollment
207
Registered
2010-09-13
Start date
2004-01-31
Completion date
2014-07-31
Last updated
2014-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multivessel Coronary Artery Disease

Keywords

multivessel coronary artery disease, drug-eluting stent, CABG, cost-effectiveness

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).

Interventions

PROCEDUREcomparison of PCI vs. CABG in multivessel disease

invasive treatment of coronary artery disease

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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)

Secondary

MeasureTime frame
Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke6 months
Rate of target vessel revascularization6 months
Occurrence of non-fatal acute myocardial infarction6 months
Occurrence of cardiac death6 months
Calculation of the total costsin-hospital phase (up to 3 weeks)

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026