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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.
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