Project Objectives

The primary objective of T.E.D. multicenter, prospective, observational electronic-based registry is to evaluate the outcome of Paclitaxel eluting Taxus Element stent in 750 Patients with diabetes mellitus who are suitable for drug-eluting stent implantation according to the applicable guidelines on percutaneous coronary interventions.

Exclusion criteria

1. Non-diabetic patients
2. Primay intervention of acute ST elevation myocardial (STEMI) infarction
3. Use of a non Taxus Element stent in the index vessel.
4. Taxus Element stent implantation in a vein graft or internal mammary graft.
5. High probability of non-compliance with study follow-up

Study End-Points

Primary end point:
MACE at 1 year consisting of cardiac death, non fatal myocardial infarction, and target vessel revascularization.

Secondary end points:

  • MACE at 2 years
  • Target vessel revascularization at 2 years.
  • Restenosis without TVR.
  • Role of diabetes treatment (insulin versus oral hypoglycaemic) on outcome.
  • Outcome in small vessels as a pre-specified sub-group as defined as ≤2.5 mm stent diameter.
  • Stent thrombosis yearly (according to the ARC definitions) up to 2 years.