Cortisone or Drug Eluting Stents (DES) as Compared to Bare Metal Stents (BMS) to EliminAte Restenosis
Condition: Coronary Artery Disease; Ischemic Heart Disease; Atherosclerosis
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Heart Diseases; Atherosclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The possibility of using the new drug eluting stents (DES) technology has significantly
      changed the mid-term outcome of percutaneous coronary interventions (PCI) in terms of reduced
      recurrence of angina. The way interventionalists accomplish their work is changing
      accordingly, with a strong trend to a wider use of DES and a consequent perceived patients'
      clinical benefit.

      Evidences supporting the superiority of DES in reducing ischemic recurrence after PCI
      compared to traditional stents (BMS) are available from randomized studies. A recent
      meta-analyses underlines that:

      DES are superior to BMS in reducing clinical recurrence of ischemia, DES and BMS offer
      identical results in terms of death and infarction, Rapamycin and paclitaxel DES offer
      similar results.

      The aim of our study is to perform a multicenter, randomized study to assess the clinical
      efficacy and safety of the oral prednisone therapy after PCI as a possible systemic
      alternative to currently available BMS and DES. Furthermore, the study aims at analyzing the
      clinical outcome of the commercially available DES in the context of an independent research
      and a cost-benefit comparison with BMS and oral steroids.
    

Detailed description: 
      Design of the study

      It is very important to underline that this is a "spontaneous" study, i.e. not receiving
      sponsorship from pharmaceutical industries, stent manufacturers, or any other financial
      source. This independence from economic interests would contribute to exclude conflicts of
      interest that may bias the results of the study that is aimed at testing the applicability
      and the clinical efficacy of this therapy. Furthermore, the assessment of the DES in public
      hospitals, and beyond the spectrum of the industry-supported studies may offer interesting
      results of the real life use of these devices.

      One of the purposes of the study is a cost-effectiveness analysis. Centers participating in
      the study should therefore perform PCI according to their common practice with no
      interference in their decision-making process or technical approach to PCI because of the
      inclusion of the patients into a randomized study; this is aimed at obtaining an as real as
      possible situation of the daily practice. Being an spontaneous research, neither a fee will
      be provided for the enrollment of patients, nor free stents will be given.

      The allocation of patients into a BMS or DES treatment will be decided by randomization, and
      the stents implanted will be selected according to the operator's preference.

      The study will include three different groups of patients:

        -  Control group: receiving BMS;

        -  DES group: receiving DES;

        -  Prednisone group: receiving BMS and oral prednisone

      Principal objective of the study: is the comparison of the primary endpoint obtained in a
      control group of patients treated with BMS versus two alternative study groups:

        -  DES

        -  BMS and oral prednisone All assuming a similar adjunctive conventional medical
           treatment.

      Secondary endpoint of the study are:

        -  cost-effectiveness analysis. This will be calculated considering all patients enrolled
           in the study and analyzed after one year of the treatment. The analysis will take into
           account the procedural cost of the PCI material, the cost of the medical treatment in
           the first year of follow-up and the number of event-free days at follow-up. The
           cost-efficacy analysis will be obtained from the ratio between the cost of the
           event-free day of follow-up and the possibility of MACE considered in the primary
           endpoint of the study.

        -  comparison of the angiographic results. This will be calculated in all patients
           enrolled.
    

Intervention name(s): Prednisone; Drug eluting coronary stent; Bare metal coronary stent
Intervention type(s): Drug; Device; Device
Intervention description(s): Bare metal stenting with administration of oral prednisone as described in the protocol; Stenting with DES (Cypher or Taxus); Stenting with BMS only
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment