The Comparative Effectiveness of Hybrid Revascularization (MIDCAB Then PCI) With DES Versus Multivessel DES PCI or CABG
Condition: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Ischemia
Study type: Interventional

Summary: 
      Minimally invasive revascularization of the left anterior descending artery followed by stent
      implantation versus percutaneous coronary intervention or coronary artery bypass in patients
      with multi-vessel coronary disease
    

Detailed description: 
      Prospective, single-center, randomized trial, intended to compare three revascularization
      strategies in patients with multi-vessel coronary artery disease:

        1. Hybrid approach (Minimally invasive off-pump revascularization of the left anterior
           descending artery (LAD) with left internal mammary artery (LIMA) bypass followed by
           consecutive percutaneous coronary intervention (PCI) in the rest of the arteries with
           drug eluting stents (DES) (Hybrid group, n=50)

        2. Multi-vessel PCI with DES (MV-PCI group, n=50)

        3. Coronary artery bypass graft (CABG) treatment (CABG group, n=50)

      PCI in Hybrid and MV-PCI group will be performed with the same 2nd generation clinically
      proven DES (Xience V, Xience Prime).

      Study objective Compare three different revascularization strategies in patients with
      multi-vessel coronary disease

      The endpoints:

      The primary endpoints:

      I. % ischemic myocardium on a 12-month follow-up scan with single photon emission computed
      tomography (SPECT);

      The secondary endpoints:

      I. Major adverse cardiac and cerebral events (MACCE), including (1) death, (2) non-fatal
      myocardial infarction (non-fatal MI), transitory ischemic attack (TIA) or stroke within 30
      days, 12 months and 5-year follow-up; II. Target vessel/graft failure (for any of the target
      vessels in a given patient - stented or grafted) = a composite of cardiac death, MI
      attributable to the target vessel, or clinically-driven [ie, not angio-driven] Target Vessel
      Revascularization (TVR); III. Restenosis = angiographically-detected target lesion stenosis
      >50% [diameter stenosis] or graft stenosis >50%; IV. Procedural success: The treatment will
      be considered successful when a revascularisation in the absence of complications during the
      index hospitalization has been achieved; V. Procedural and post-procedural hemorrhagic
      complications [ Time Frame: up to discharge from the hospital ]; VI. Recovery time [ Time
      Frame: up to discharge from the hospital ];
    

Intervention name(s): Hybrid (MIDCAB+PCI); PCI; CABG
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Hybrid approach (Minimally invasive of-pump revascularization of the left anterior descending artery (LAD) via left internal mammary artery (LIMA) bypass with consecutive percutaneous coronary intervention (PCI) in the rest arteries with drug eluting stents (DES). The revascularization will be performed in two stages within a 3-days interval; Multi-vessel PCI with DES; Coronary artery bypass graft (CABG) treatment
Other intervention name(s): MIDCAB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multivessel PCI,MIDCAB,CABG; Hybrid coronary revascularization