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Completed

NCT Number: NCT01199419

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna, Dept. of Cardiology

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

comparison of PCI vs. CABG in multivessel disease

Procedure

invasive treatment of coronary artery disease

Primary outcomes

  1. Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.

    Time frame: in-hospital phase (up to 3 weeks)

  2. Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.

    Time frame: 6 months

  3. Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.

    Time frame: 12 months

  4. Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.

    Time frame: 5 years

  5. Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.

    Time frame: 10 years

Secondary outcomes

  1. Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke

    Time frame: 6 months

  2. Rate of target vessel revascularization

    Time frame: 6 months

  3. Occurrence of non-fatal acute myocardial infarction

    Time frame: 6 months

  4. Occurrence of cardiac death

    Time frame: 6 months

  5. Calculation of the total costs

    Time frame: in-hospital phase (up to 3 weeks)

  6. Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke

    Time frame: 12 months

  7. Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke

    Time frame: 5 years

  8. Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke

    Time frame: 10 years

  9. Rate of target vessel revascularization

    Time frame: 12 months

  10. Rate of target vessel revascularization

    Time frame: 5 years

  11. Rate of target vessel revascularization

    Time frame: 10 years

  12. Occurrence of non-fatal acute myocardial infarction

    Time frame: 12 months

  13. Occurrence of non-fatal acute myocardial infarction

    Time frame: 5 years

  14. Occurrence of non-fatal acute myocardial infarction

    Time frame: 10 years

  15. Occurrence of cardiac death

    Time frame: 12 months

  16. Occurrence of cardiac death

    Time frame: 5 years

  17. Occurrence of cardiac death

    Time frame: 10 years

  18. Calculation of the total costs

    Time frame: 6 months

  19. Calculation of the total costs

    Time frame: 12 months

  20. Calculation of the total costs

    Time frame: 5 years

  21. Calculation of the total costs

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2014
Study completion
2014
First posted
Sep 13, 2010
Registry last updated
Jul 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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