Austrian Multivessel Taxus-Stent Registry (AUTAX)

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:

1. 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..
2. 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.
3. 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.
4. To evaluate potential cost burden in attempting a strategy of complete revascularization by multiple DES in patients with multivessel disease.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Intracoronary stent implantation

• Study Type: Interventional
• Enrollment (Actual): 441
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Bruck an der Mur, Austria
    • Landeskrankenhaus
  • Feldkirch, Austria
    • Department of Interventional Cardiology, Academic Hospital
  • Graz, Austria
    • Landeskrankenhaus Graz-West
  • Linz, Austria
    • Allgemeines Krankenhaus der Stadt Linz
  • Linz, Austria
    • Krankenhaus Barmherzigen Schwestern
  • Salzburg, Austria
    • St. Johannes Spital
  • Vienna, Austria
    • Rudolfstiftung

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Helmut-Dietmar Glogar, MD FESC, Dept. Cardiology, Medical University of Vienna, Vienna, Austria

Publications and helpful links

General Publications

• Gyongyosi M, Christ G, Lang I, Kreiner G, Sochor H, Probst P, Neunteufl T, Badr-Eslam R, Winkler S, Nyolczas N, Posa A, Leisch F, Karnik R, Siostrzonek P, Harb S, Heigert M, Zenker G, Benzer W, Bonner G, Kaider A, Glogar D; AUTAX Investigators. 2-year results of the AUTAX (Austrian Multivessel TAXUS-Stent) registry beyond the SYNTAX (synergy between percutaneous coronary intervention with TAXUS and cardiac surgery) study. JACC Cardiovasc Interv. 2009 Aug;2(8):718-27. doi: 10.1016/j.jcin.2009.05.019.

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: August 19, 2008
• First Submitted That Met QC Criteria: August 19, 2008
• First Posted (Estimate): August 20, 2008

Study Record Updates

• Last Update Posted (Estimate): August 21, 2008
• Last Update Submitted That Met QC Criteria: August 20, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; coronary artery disease; drug-eluting stent; stent thrombosis; major adverse cardiac event; in-stent restenosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: AUTAX