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Instead 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 percutaneous coronary intervention (PCI).
Objective of the study:
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.
Approximately 1600 consecutive patients with coronary artery disease who are eligible according to the in- and exclusion criteria will be enrolled and randomized on a 1:1 basis.
Primary study parameters/outcome of the study:
The primary end point of the study is the composite end point of: all death, non fatal myocardial infarction, target vessel revascularization at 1 year.
Secondary study parameters/outcome of the study:
The secondary end points of the study are:
A) The combined endpoint of cardiac death, non fatal myocardial infarction, ischemic driven target lesion revascularization (TLR) rate at 1, 6 and 12 months follow-up.
B) The combined endpoint of all death, non fatal myocardial infarction, target vessel revascularization (TVR) rate at 2, 3, 4 and 5 years.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The burden for the patient consists of filling in 8 questionnaires (1 A4 per questionnaire) in 5 years time.
The first 3 questionnaires 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. The patient will receive a Taxus or Xience-V stent anyhow, if the indication for a DES stent exists.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
everolimus stent, paclitaxel stent
Published on BioPortfolio: 2014-07-23T21:11:46-0400
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