open access

Vol 69, No 5 (2011)
Original articles
Published online: 2011-05-18
Submitted: 2012-12-28
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Prospective randomised pilOt study evaLuating the safety and efficacy of hybrid revascularisation in MultI−vessel coronary artery DisEaSe (POLMIDES) — study design

Marian Zembala, Mateusz Tajstra, Michał Zembala, Krzysztof Filipiak, Piotr Knapik, Tomasz Hrapkowicz, Marek Gierlotka, Michał Hawranek, Lech Poloński, Mariusz Gąsior
Kardiol Pol 2011;69(5):460-466.

open access

Vol 69, No 5 (2011)
Original articles
Published online: 2011-05-18
Submitted: 2012-12-28

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).
Aim: 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

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).
Aim: 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
Get Citation

Keywords

multivessel coronary artery disease; hybrid revascularisation; clinical pilot trial; study design

About this article
Title

Prospective randomised pilOt study evaLuating the safety and efficacy of hybrid revascularisation in MultI−vessel coronary artery DisEaSe (POLMIDES) — study design

Journal

Kardiologia Polska (Polish Heart Journal)

Issue

Vol 69, No 5 (2011)

Pages

460-466

Published online

2011-05-18

Bibliographic record

Kardiol Pol 2011;69(5):460-466.

Keywords

multivessel coronary artery disease
hybrid revascularisation
clinical pilot trial
study design

Authors

Marian Zembala
Mateusz Tajstra
Michał Zembala
Krzysztof Filipiak
Piotr Knapik
Tomasz Hrapkowicz
Marek Gierlotka
Michał Hawranek
Lech Poloński
Mariusz Gąsior

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