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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mariann Gyongyosi, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01199419
First received: September 9, 2010
Last updated: June 10, 2012
Last verified: June 2012
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
  • Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Rate of target vessel revascularization [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Occurrence of non-fatal acute myocardial infarction [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Occurrence of cardiac death [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Calculation of the total costs [ Time Frame: in-hospital phase (up to 3 weeks) ] [ Designated as safety issue: Yes ]
  • Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Rate of target vessel revascularization [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Rate of target vessel revascularization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Rate of target vessel revascularization [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Occurrence of non-fatal acute myocardial infarction [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Occurrence of non-fatal acute myocardial infarction [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Occurrence of non-fatal acute myocardial infarction [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Occurrence of cardiac death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Occurrence of cardiac death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Occurrence of cardiac death [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Calculation of the total costs [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Calculation of the total costs [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Calculation of the total costs [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Calculation of the total costs [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Enrollment: 207
Study Start Date: January 2004
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199419

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

No publications provided

Responsible Party: Mariann Gyongyosi, MD PhD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01199419     History of Changes
Other Study ID Numbers: Version 1
Study First Received: September 9, 2010
Last Updated: June 10, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by 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

ClinicalTrials.gov processed this record on April 14, 2014