A Trial Comparing a Paclitaxel Eluting Stent With Biodegradable Polymer Versus a Bare Metal Stent (EUCATAX)

• Stent thrombosis [ Time Frame: one year ] [ Designated as safety issue: Yes ]
• Paclitaxel allergy [ Time Frame: six months ] [ Designated as safety issue: Yes ]
• Cost-effectiveness [ Time Frame: one year ] [ Designated as safety issue: No ]
• Quantitative Coronary Angiography [ Time Frame: six months ] [ Designated as safety issue: No ]

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.

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.

• Device: Bare Metal Stent
  Stainless steel stent
  Other Name: Euca STS Flex
• Device: Drug Eluting Stent
  stent coated with the biodegradable polymer matrix hemoparin and paclitaxel
  Other Name: Euca STS Flex DE

• Active Comparator: 1-BMS
  Bare Metal Stent (Euca STS Flex)
  Intervention: Device: Bare Metal Stent
• Experimental: 2-DES
  Drug Eluting Stent (Euca STS Flex DE), Paclitaxel Eluting stent with biodegradable polymer
  Intervention: Device: Drug Eluting Stent

• 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.
• 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.
• Serruys PW, Unger F, Sousa JE, Jatene A, Bonnier HJ, Schönberger 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.
• 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. Epub 2010 Nov 30.

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%)