Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease

Inclusion Criteria:

• Stable, or unstable angina and/or objective signs of myocardial ischaemia
• Informed consent
• Optimal result (< 35% residual stenosis and < type C dissection) after balloon angioplasty
• Lesions should be de novo and located in native vessels with a diameter > 2.25 mm.

• Complex lesions to be included should have at least one of the following characteristics:

  • ostial in location (< 5 mm from ostium)
  • total occlusions with a length ≥ 15 mm
  • bifurcational (side branch > 1.75 mm in diameter)
  • angulated (> 45° within lesion)

Exclusion criteria:

Patients:

• Other severe disease with an expected survival < 1 year
• Other significant cardiac disease
• Known allergy against paclitaxel, clopidogrel (or ticlopidine),
• Myocardial infarction within 3 days of the index procedure
• Linguistic difficulties needing an interpreter
• Renal insufficiency (p-creatinine > 200 micromol/l)
• Gastrointestinal bleeding within 1 month
• Childbearing potential or pregnancy
• Participation in another study

Lesions:

• Unprotected left main disease
• Restenosis
• Lesions containing visible thrombus
• Treatment with other modality than balloon or stent (ablation, brachytherapy, ultrasound) in connection with the index procedure
• Diffuse coronary disease distal to the treated lesion
• Heavily calcification
• Lesion located in saphenous vein graft