Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions

TAXUS V: De Novo Lesion: A Randomized, Double-blind Trial to Assess TAXUS Paclitaxel-Eluting Coronary Stents, SR Formulation, in the Treatment of De Novo Coronary Lesions

The primary objective of this study is to further evaluate the safety and effectiveness of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System in long lesion lengths, small and large vessel diameters and with multiple overlapping stents in the treatment of de novo coronary artery lesions

The primary endpoint is the incidence rate of TVR through 9 months post index procedure. In this protocol, TVR must be ischemia driven, based on the presence of symptoms, positive functional testing or Quantitative Coronary Angiography (QCA) severity of restenosis.

Secondary endpoints include the following:

• Incidence rates of composite MACE and the individual components of MACE assessed at discharge, 1, 4 and 9 months post index procedure and annually for 5 years (i.e., 1, 2, 3, 4 and 5 years post index procedure).

• Stent thrombosis rate.

• TVF.

• Clinical procedural success and technical success.

• Binary restenosis rate.

• Additional angiographic endpoints to be measured in all patients with 9 month angiographic follow-up include:

  • Absolute lesion length
  • Reference Vessel Diameter (RVD)
  • Minimum Lumen Diameter (MLD)
  • Percent diameter stenosis (% DS)
  • Acute gain
  • Late loss
  • Loss index
  • Patterns of recurrent restenosis, including edge effect
  • Coronary aneurysm

• IVUS Substudy

  • Identification of potential safety issues, i.e., incomplete stent apposition.
  • change in neointimal volume from post procedure to follow-up
  • change in MLD within stent
  • minimum lumen area (MLA) within stent
  • lumen, plaque and vessel measurements at the stent edges (outside stent)

Inclusion Criteria:

• Patient was ≥ 18 years old.
• Eligible for percutaneous coronary intervention.
• Documented stable angina pectoris.
• LVEF of greater than 25%.
• Acceptable candidate for coronary artery bypass grafting.
• Target lesion segment is located within a single native coronary vessel.
• Target lesion was de novo.
• RVD was greater than 2.25 mm and less than 4.0 mm .and patient and/or lesion fulfilled protocol defined subgroups.
• Cumulative target lesion length was greater than 10 mm and less than 46mm assessed after pre-dilatation with standard balloon or cutting balloon angioplasty, including adjacent areas of dissection that were covered.
• Target lesion diameter stenosis less than 50% before pre-dilatation .
• Vessel and lesion morphology such that the lesion was treated only with study stent(s); no planned use of commercial stents.

Exclusion Criteria:

• Known hypersensitivity to paclitaxel.
• Any previous or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent.
• Planned use of both the study stent and a non-study stent in the treatment of the target vessel.
• Previous or planned treatment with intravascular brachytherapy in the target vessel.
• Recent MI.
• CK-MB greater than 2x the local laboratory's upper limit of normal.
• Cerebrovascular accident within 6 months of randomization.
• Planned CABG ≤ 9 months post index procedure.
• Acute or chronic renal dysfunction.
• Leukopenia.
• Thrombocytopenia or thrombocytosis.
• Active peptic ulcer or active gastrointestinal bleeding, or previously active within 6 months.
• Known allergy to stainless steel.
• Any prior true anaphylactic reaction to contrast agents.
• Contraindication to ASA or to both clopidogrel and ticlopidine.
• Patient was on warfarin or it was anticipated that treatment with warfarin would have been required during any period within 6 months post the index procedure.
• Patient was or had been treated with chemotherapeutic agents within 12 months of the index procedure.
• Anticipated treatment with paclitaxel, oral rapamycin or colchicine during any period in the 9 months post index procedure.
• Male or female with known intention to procreate within 3 months post index procedure.
• Co-morbid condition(s) that could limit the patient's ability to participate in the study, limit compliance with follow-up requirements or impact the scientific integrity of the study.
• Planned surgical procedure requiring withdrawal of any anti-platelet therapy within 6 months post index procedure.
• Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
• Unprotected left main coronary artery disease.
• Target lesion was ostial in location.
• Target lesion and/or target vessel proximal to the target lesion was moderately or severely calcified.
• Target lesion was located within or distal to a > 60° bend in the vessel.
• Side branch of the target lesion included ostial narrowing ≥ 50% DS and was ≥ 2.0 mm diameter.
• Target lesion was totally occluded.
• Angiographic presence of probable or definite thrombus.