title: Prospective randomised pilOt study evaLuating the safety and efficacy of hybrid revascularisation in MultI-vessel coronary artery DisEaSe (POLMIDES) - study design.
abstract: BACKGROUND
  Hybrid coronary artery revascularisation (HCR) is a combination of minimally invasive left internal mammary artery bypass grafting to the left anterior descending artery (LAD) and percutaneous coronary interventions (PCI) with drug eluting stent implantation to other coronary arteries. Due to the paucity of data from large, prospective randomised trials comparing HCR to standard surgical revascularisation, the POLMIDES study has been designed to assess the safety and efficacy of HCR in patients with multivessel coronary artery disease (CAD) referred for standard coronary artery bypass grafting (CABG).
  
  
  OBJECTIVE
  The primary objective is evaluating the feasibility and safety of HCR.
  
  
  METHODS
  Feasibility has been defined by means of the percentage of patients with a complete hybrid procedure according to the study protocol and a percentage of conversion to standard CABG. Safety has been defined as the occurrence of major adverse cardiac events such as death, myocardial infarction, stroke, repeat revascularisation and major bleeding within the 12 month period after randomisation. All consecutive patients with angiographically confirmed multivessel CAD involving LAD and a critical (> 70%) lesion in at least one major epicardial vessel (except LAD) amenable to both PCI and CABG referred for conventional surgical revascularisation, will be randomised in a 1:1 fashion for HCR or standard surgical revascularisation.
  
  
  CONCLUSIONS
  The POLMIDES is a prospective, randomised pilot trial designed to determine whether HCR in patients with multivessel CAD referred for conventional CABG is safe, feasible and efficacious (ClinicalTrials.gov number, NCT01035567). Kardiol Pol 2011; 69, 5: 460-466.
authors: Department of Cardiac Surgery and Transplantology, Silesian Centre for Heart Diseases, Medical University of Silesia, Zabrze, Poland.
authors: Marian
authors: M
authors: Zembala
authors: Mateusz
authors: M
authors: Tajstra
authors: Michał
authors: M
authors: Zembala
authors: Krzysztof
authors: K
authors: Filipiak
authors: Piotr
authors: P
authors: Knapik
authors: Tomasz
authors: T
authors: Hrapkowicz
authors: Marek
authors: M
authors: Gierlotka
authors: Michał
authors: M
authors: Hawranek
authors: Lech
authors: L
authors: Poloński
authors: Mariusz
authors: M
authors: Gąsior