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

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ClinicalTrials.gov Identifier: NCT01199419
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : July 18, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment
Multivessel Coronary Artery Disease Procedure: comparison of PCI vs. CABG in multivessel disease

Study Design

Study Type : Observational
Actual Enrollment : 207 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : January 2004
Primary Completion Date : July 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients, treated with multivessel disease requiring revascularization were consecutively included in this study.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199419


Locations
Austria
Medical University of Vienna, Dept. of Cardiology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
More Information

Responsible Party: Mariann Gyongyosi, MD PhD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01199419     History of Changes
Other Study ID Numbers: Version 1
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014

Keywords provided by Mariann Gyongyosi, Medical University of Vienna:
multivessel coronary artery disease
drug-eluting stent
CABG
cost-effectiveness

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases