Clinical trial NCT01199419: Cost-effectiveness of PCI With Taxus vs CABG - 5 Years FUP
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multivessel Coronary Artery Disease
Keywords: multivessel coronary artery disease
drug-eluting stent
CABG
cost-effectiveness
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2010-09-13
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients, treated with multivessel disease requiring revascularization were consecutively included in this study.

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).


Eligibility 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

Primary outcomes:
measure: Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.
timeFrame: in-hospital phase (up to 3 weeks)
measure: Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.
timeFrame: 6 months
measure: Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.
timeFrame: 12 months
measure: Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.
timeFrame: 5 years
measure: Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.
timeFrame: 10 years
Secondary outcomes:
measure: Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke
timeFrame: 6 months
measure: Rate of target vessel revascularization
timeFrame: 6 months
measure: Occurrence of non-fatal acute myocardial infarction
timeFrame: 6 months
measure: Occurrence of cardiac death
timeFrame: 6 months
measure: Calculation of the total costs
timeFrame: in-hospital phase (up to 3 weeks)
measure: Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke
timeFrame: 12 months
measure: Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke
timeFrame: 5 years
measure: Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke
timeFrame: 10 years
measure: Rate of target vessel revascularization
timeFrame: 12 months
measure: Rate of target vessel revascularization
timeFrame: 5 years
measure: Rate of target vessel revascularization
timeFrame: 10 years
measure: Occurrence of non-fatal acute myocardial infarction
timeFrame: 12 months
measure: Occurrence of non-fatal acute myocardial infarction
timeFrame: 5 years
measure: Occurrence of non-fatal acute myocardial infarction
timeFrame: 10 years
measure: Occurrence of cardiac death
timeFrame: 12 months
measure: Occurrence of cardiac death
timeFrame: 5 years
measure: Occurrence of cardiac death
timeFrame: 10 years
measure: Calculation of the total costs
timeFrame: 6 months
measure: Calculation of the total costs
timeFrame: 12 months
measure: Calculation of the total costs
timeFrame: 5 years
measure: Calculation of the total costs
timeFrame: 10 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Dept. of Cardiology
Study officials:
References: