Clinical trial NCT00738686: Austrian Multivessel Taxus-Stent Registry
Official title: Austrian Multivessel Taxus-Stent Registry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
drug-eluting stent
percutaneous coronary intervention
major adverse cardiac event
in-stent restenosis
stent thrombosis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-08-20
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 2 year
Secondary outcomes:
measure: 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
timeFrame: 2 year
measure: Incidence of 30-days, 6-mo and 1-year MACCE
timeFrame: 1 year
measure: Acute, subacute and late thrombosis rates
timeFrame: 2 year
measure: 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
timeFrame: 6-month
Other outcomes:
Locations:
city: Bruck an der Mur
country: Austria
facility: Landeskrankenhaus
city: Feldkirch
country: Austria
facility: Department of Interventional Cardiology, Academic Hospital
city: Graz
country: Austria
facility: Landeskrankenhaus Graz-West
city: Linz
country: Austria
facility: Allgemeines Krankenhaus der Stadt Linz
city: Linz
country: Austria
facility: Krankenhaus Barmherzigen Schwestern
city: Salzburg
country: Austria
facility: St. Johannes Spital
city: Vienna
country: Austria
facility: Rudolfstiftung
Study officials:
affiliation: Dept. Cardiology, Medical University of Vienna, Vienna, Austria
name: Helmut-Dietmar Glogar, MD FESC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.