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

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.

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%)