Clinical trial NCT00825279: A Trial Comparing a Paclitaxel Eluting Stent With Biodegradable Polymer Versus a Bare Metal Stent
Official title: Comparison Among a Paclitaxel Eluting Stent With Biodegradable Polymer Versus an Uncoated Bare Metal Stent. A Prospective, Multicentric and Randomized Study.(EUCATAX Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Biodegradable polymer
Drug Eluting Stent
In stent restenosis
stent thrombosis
Bare Metal Stent
Lead sponsor: Centro de estudios en Cardiologia Intervencionista
Sponsor class: OTHER
Collaborators: name: Eucatech AG
First posted: 2009-01-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The success of stent implantation has led to the increasingly widespread use of them in the treatment of coronary artery disease (Sigwart, Serruys, Fischman)and although stent restenosis is still a limit for this therapeutic mode (Serruys, Rodriguez) the new generation of stents with improved coating materials and the development of polymers that release different kinds of drugs that prevent the activation and/or proliferation of smooth muscle cells (ultimate cause of restenosis) (Grube, Rodriguez). shows major improvements on this matter. The new generation of stents with biodegradable polymers and short time of drug release gives new advantages to this therapeutic, multiple studies and registries challenge this new devices (Taxus I and II, RAVEL, SIRIUS, ERACI II and III).

For this reason the present study aims to compare a stainless steel stent with a drug eluting stent with coated of biodegradable polymer matrix hemoparin and paclitaxel.

Detailed description: Patients with de novo lesions treated in different Institutions in Buenos Aires Argentina were randomized to treat with a stainless steel stent ("euca STS Flex") or a drug-eluting stent (" euca STS Flex DE") with a coating of a biodegradable polymer matrix of hemoparin and paclitaxel.

Eligibility criteria: Inclusion Criteria:

* Patient signing informed consent after receiving extensive written and oral information about the trial,
* Older than 18 years,
* Agreement to have a control examination done after six months,
* Patients with angina pectoris symptoms (CCS stages i-IV, unstable angina pectoris Braunwald B and C) and patients with documented silent ischemia;
* Patients with one or more de novo lesions which all are to be dilated in the same session;
* Target vessel diameter of 2.5 to 4.0 mm

Exclusion Criteria:

* Female patients of child bearing age with pregnancy suspicion(a pregnancy test will be done in this cases)
* Acute myocardial infarction (Q wave or non Q wave ) with documented CK levels more than 2 fold higher than the normal values in the preceding 72 hours ,
* Substantially calcified lesion precluding successful pre dilatation,
* Ejection Fraction less than 35%,
* Patient with previous PCI with one DES,
* Target lesion \< 2.5 mm
* Coagulopathy or clotting disorders, leucopenia anemia or thrombocytopenia,
* Allergy, hypersensitivity or adverse reaction to paclitaxel,
* Intolerance to the clopidogrel, Ticlopidine or Aspirin or unable to receive clopidogrel for one year,
* Active duodenal or gastric ulcer,
* Life Expectancy less than 1 year,
* Patient with LM disease (\>50%)

Primary outcomes:
measure: Target Vessel Failure
timeFrame: six months
Secondary outcomes:
measure: Stent thrombosis
timeFrame: one year
measure: Paclitaxel allergy
timeFrame: six months
measure: Cost-effectiveness
timeFrame: one year
measure: Quantitative Coronary Angiography
timeFrame: six months
Other outcomes:
Locations:
city: Adrogue
country: Argentina
facility: Clinica IMA
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Sanatorio Otamendi y Miroli
Study officials:
affiliation: Centro de estudios en Cardiologia Intervencionista
name: Alfredo E Rodriguez, MD, PHD
role: STUDY_CHAIR
affiliation: Centro de estudios en Cardiologia Intervencionista
name: Carlos Fernandez-Pereira, MD
role: STUDY_DIRECTOR
affiliation: Centro de Estudios en Cardiologia Internvencionista
name: Alfredo E Rodriguez, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6. doi: 10.1056/NEJM198703193161201.
citation: Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801.
citation: Serruys PW, Unger F, Sousa JE, Jatene A, Bonnier HJ, Schonberger JP, Buller N, Bonser R, van den Brand MJ, van Herwerden LA, Morel MA, van Hout BA; Arterial Revascularization Therapies Study Group. Comparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease. N Engl J Med. 2001 Apr 12;344(15):1117-24. doi: 10.1056/NEJM200104123441502.
citation: Rodriguez AE, Vigo CF, Delacasa A, Mieres J, Fernandez-Pereira C, Bernardi V, Bettinoti M, Rodriguez-Granillo AM, Rodriguez-Granillo G, Santaera O, Curotto V, Rubilar B, Tronge J, Palacios IF, Antoniucci D; EUCATAX Investigators. Efficacy and safety of a double-coated paclitaxel-eluting coronary stent: the EUCATAX trial. Catheter Cardiovasc Interv. 2011 Feb 15;77(3):335-42. doi: 10.1002/ccd.22769. Epub 2010 Nov 30.