Austrian Multivessel Taxus-Stent Registry

Study Overview
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Brief Summary
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The aim of AUTAX study is to investigate the frequency of MACCE in patients with multivessel disease and multiple Taxus stent implantations in the real world stenting at 30 days, 6 and 12 months at 2 year follow-up. Because multivessel stenting using DES has been limited due to economic considerations, the secondary aim is to enhance experience in multivessel stenting with drug-eluting stents in order to improve short- and long-term outcomes of the patients with severe multiple coronary artery stenoses. The objectives of the study are: To determine the frequency of MACCE at 30-day, 6 and 12-month and at 2 year clinical follow-up after multivessel intervention with drug-eluting stents in a prospective patient cohort.. To determine the rate of in-stent restenosis, target lesion and target vessel revascularization (angiographic measures) 6 months in patients with multiple DESs in multiple lesions. To investigate the clinical and angiographic outcomes after implantation of multiple DESs in the subgroup of patients with accompanying diseases (diabetes mellitus, renal insufficiency) with known high restenosis and late complication rate. To evaluate potential cost burden in attempting a strategy of complete revascularization by multiple DES in patients with multivessel disease.

Official Title
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Austrian Multivessel Taxus-Stent Registry

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Intracoronary stent implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptomatic coronary multivessel disease possible percutaneous complete coronary revascularization age >18 year significant coronary lesion at least in 2 vessels Exclusion Criteria: acute myocardial infarction within 48 hours contraindications to clopidogrel, aspirin, heparin and taxol pregnancy or lack of protection against pregnancy or breast-feeding during the study hemorrhagic diathesis platelet count <100.000/ml3

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Single-arm study, no placebo or control group | Device: Intracoronary stent implantation<br>* Taxus stent implantation in patients with multivessel coronary artery disease<br>* Other names: Taxus Liberte;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of MACCE, defined as all-cause death, nonfatal acute myocardial infarction (AMI) target vessel revascularization (TVR) and cerebrovascular event during the two-year clinical follow-up (FUP) |  | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Break-down primary endpoints at the 2-year FUP, as the rate of TVR, non-fatal AMI, all-cause death, stroke and the composite of death and AMI |  | 2 year | 
| Incidence of 30-days, 6-mo and 1-year MACCE |  | 1 year | 
| Acute, subacute and late thrombosis rates |  | 2 year | 
| Angiographic end-points as the binary restenosis rate per lesion (defined as diameters stenosis ≥ 50%), in-stent and proximal and distal in-lesion late lumen loss |  | 6-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, drug-eluting stent, percutaneous coronary intervention, major adverse cardiac event, in-stent restenosis, stent thrombosis