Multivessel Coronary Artery DiseaseNCT01199419
Cost-effectiveness of PCI With Taxus vs CABG - 5 Years FUP
An observational study of Multivessel Coronary Artery Disease, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multivessel Coronary Artery Disease
- What is being tested?
- comparison of PCI vs. CABG in multivessel disease
- Type of treatment
- Surgery or procedure
- How many people
- 207 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2004to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, treated with multivessel disease requiring revascularization were consecutively included in this study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Multivessel Coronary Artery Disease
- Being tested
- comparison of PCI vs. CABG in multivessel disease
- Keywords
- multivessel coronary artery disease, drug-eluting stent, CABG, cost-effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison of PCI vs. CABG in multivessel diseaseProcedure or surgery
invasive treatment of coronary artery disease
| Study group | Role | What they receive |
|---|---|---|
| PCI | Not described Receives: Procedure: comparison of PCI vs. CABG in multivessel disease | |
| CABG | Not described Receives: Procedure: comparison of PCI vs. CABG in multivessel disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.
Measured: in-hospital phase (up to 3 weeks)
Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.
Measured: 6 months
Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.
Measured: 12 months
Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.
Measured: 5 years
Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.
Measured: 10 years
Secondary outcomes (21)
Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke
Measured: 6 months
Rate of target vessel revascularization
Measured: 6 months
Occurrence of non-fatal acute myocardial infarction
Measured: 6 months
Occurrence of cardiac death
Measured: 6 months
Calculation of the total costs
Measured: in-hospital phase (up to 3 weeks)
Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke
Measured: 12 months
Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke
Measured: 5 years
Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke
Measured: 10 years
Rate of target vessel revascularization
Measured: 12 months
Rate of target vessel revascularization
Measured: 5 years
Rate of target vessel revascularization
Measured: 10 years
Occurrence of non-fatal acute myocardial infarction
Measured: 12 months
Occurrence of non-fatal acute myocardial infarction
Measured: 5 years
Occurrence of non-fatal acute myocardial infarction
Measured: 10 years
Occurrence of cardiac death
Measured: 12 months
Occurrence of cardiac death
Measured: 5 years
Occurrence of cardiac death
Measured: 10 years
Calculation of the total costs
Measured: 6 months
Calculation of the total costs
Measured: 12 months
Calculation of the total costs
Measured: 5 years
Calculation of the total costs
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startJan 2004
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multivessel Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariann Gyongyosi, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199419
- Sponsor's protocol ID
- Version 1
- Status last verified
- Jul 2014
- First submitted
- 9 Sep 2010
- Last updated
- 18 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01199419
- Acronym / sponsor ID
- Version 1
- Conditions
- Multivessel Coronary Artery Disease
- Keywords
- multivessel coronary artery disease, drug-eluting stent, CABG, cost-effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCI | – | Procedure: comparison of PCI vs. CABG in multivessel disease |
| CABG | – | Procedure: comparison of PCI vs. CABG in multivessel disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, treated with multivessel disease requiring revascularization were consecutively included in this study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comparison of PCI vs. CABG in multivessel diseaseinvasive treatment of coronary artery disease | Procedure or surgery | CABG, PCI |
Primary outcome
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)
Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.
Time frame: 6 months
Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.
Time frame: 12 months
Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.
Time frame: 5 years
Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.
Time frame: 10 years
21 secondary outcomes
Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke
Time frame: 6 months
Rate of target vessel revascularization
Time frame: 6 months
Occurrence of non-fatal acute myocardial infarction
Time frame: 6 months
Occurrence of cardiac death
Time frame: 6 months
Calculation of the total costs
Time frame: in-hospital phase (up to 3 weeks)
Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke
Time frame: 12 months
Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke
Time frame: 5 years
Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke
Time frame: 10 years
Rate of target vessel revascularization
Time frame: 12 months
Rate of target vessel revascularization
Time frame: 5 years
Rate of target vessel revascularization
Time frame: 10 years
Occurrence of non-fatal acute myocardial infarction
Time frame: 12 months
Occurrence of non-fatal acute myocardial infarction
Time frame: 5 years
Occurrence of non-fatal acute myocardial infarction
Time frame: 10 years
Occurrence of cardiac death
Time frame: 12 months
Occurrence of cardiac death
Time frame: 5 years
Occurrence of cardiac death
Time frame: 10 years
Calculation of the total costs
Time frame: 6 months
Calculation of the total costs
Time frame: 12 months
Calculation of the total costs
Time frame: 5 years
Calculation of the total costs
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multivessel Coronary Artery Disease, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2014.