Comparison of the everolimus eluting XIENCE-V* stent with the paclitaxel eluting TAXUS* stent in all-comers: a randomized open label study.

In stead of treating in-stent restenosis, the best strategy for patients is
preventing in-stent restenosis. Recent advances in the understanding of the
cellular mechanism responsible for smooth muscle cell proliferation (neointimal
hyperplasia), together with improvement in stent coating and eluting technology
have provided the scientific background to develop drug eluting stents. Drug
eluting stents (DES) are now the most promising development in interventional
cardiology. Different classes of drugs mounted in a polymer layer on the
surface of the stent have shown to be very effective in preventing neointimal
hyperplasia. Currently there are 7 DES stents CE marked and commercially
available on the market. Two stents, respectively the sirolimus eluting Cypher*
stent and the paclitaxel eluting Taxus* stent, are in clinical use since 2002.
The Cypher* stent consists of the Bx sonic stent/balloon platform. The stent is
coated with a non-degradable biocompatible PBMA/PEVA polymer which elutes
sirolimius. The Taxus* stent consists of the Express2 balloon/stent platform
coated with non-degradable biocompatible Translute* polymer which elutes
paclitaxel.
Recent large randomized trials like RAVEL, SIRIUS, E-SIRIUS C-SIRIUS (Cypher*
versus bare metal BX sonic* stent), TAXUS II, IV, V, VI (Taxus versus bare
metal Express* stent) have shown that DES dramatically reduce the incidence of
in-stent restenosis and subsequently the need for target lesion
revascularization in patients with non complex and moderate long de-novo
coronary lesions in vessels with a diameter between 2.5 -3.5 mm.1-11
Considering the very encouraging results of these early clinical trials with so
far mid long term follow-up, there is the need to explore the utilization of
DES in the other subsets of coronary lesions like: long lesions, chronic total
occlusions, venous graft lesions, thrombotic lesions, restenosis lesions,
ostial and bifurcation lesions and lesions in large vessels.
As the result from the previous reported randomized trials, FDA and other
regulatory institutes require that new DES are now being evaluated against one
of the former DES (Cypher or Taxus). The XIENCE-V stent is a second generation
DES, with thinner and more flexible Cobalt-Chromium stent struts, compared to
the first generation Stainless Steel stent struts of Cypher and Taxus. This
study addresses the questions whether the XIENCE-V* stent has superior clinical
results as the Taxus* stent in the general population that is being referred
for PCI.

The main objective of the study is a head tot head comparison of the everolimus
coated XIENCE-V* stent with the paclitaxel coated TAXUS* stent in order to
observe whether there is a difference in clinical outcome between both stents.
Efficacy of both stents will be assessed by the composite end point of: all
death, non fatal myocardial infarction and target vessel revascularization.

Single center, randomised, open label study in all-comers referred for PCI

The burden for the patient consists of filling in 8 questionaires (1 A4 per
questionaire) in 5 years time.
The first 3 questionaires in the first year are also requested for monitoring
purposes by the Ministry of Health and the Dutch Cardiology Society
(Nederlandse Vereniging Voor Cardiologie; NVVC).

There is no risk for the patient related to participation in this study.
Thepatient will receive a Taxus or Xience-V stent anyhow, if the indication for
a DES stent exsists.