A Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial
Condition: Stable Angina; Unstable Angina; Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Angina Pectoris; Angina, Stable; Angina, Unstable
Study type: Interventional
Phase: Phase 3

Summary: 
      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.

      Study design:

      Single center, randomised, open label study in all-comers referred for PCI.

      Study population:

      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.
    


Intervention name(s): everolimus stent; paclitaxel stent
Intervention type(s): Device; Device
Intervention description(s): stenting; stenting
Intervention MeSH terms: Paclitaxel; Everolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: drug-eluting stent; stable angina; ACS; MACE; safety; stent thrombosis