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Prospective randomised pilOt study evaLuating the safety and efficacy of hybrid revascularisation in MultI-vessel
Marian Zembala1, Mateusz Tajstra, Michał Zembala
1Department of Cardiac Surgery and Transplantology, Silesian Centre for Heart Diseases, Medical University of Silesia, Zabrze, Poland.
Insights
Hybrid coronary artery revascularisation (HCR) combines minimally invasive bypass grafting with percutaneous coronary intervention (PCI). The POLMIDES trial assesses HCR
Area of Science:
- Cardiovascular Surgery
- Interventional Cardiology
- Clinical Trials
Background:
- Hybrid coronary artery revascularisation (HCR) integrates minimally invasive left internal mammary artery bypass grafting to the left anterior descending artery (LAD) with percutaneous coronary interventions (PCI) using drug-eluting stents for other coronary arteries.
- Limited data exists from large, prospective randomized trials comparing HCR to standard surgical revascularisation.
- The POLMIDES study was designed to evaluate HCR's safety and efficacy in multivessel coronary artery disease (CAD) patients.
Purpose of the Study:
- To evaluate the feasibility and safety of Hybrid Coronary Artery Revascularisation (HCR).
Main Methods:
- A 1:1 randomization of patients with multivessel CAD involving LAD and other critical lesions to either HCR or standard coronary artery bypass grafting (CABG).
- Feasibility assessed by the percentage of complete hybrid procedures and conversions to standard CABG.
- Safety defined by major adverse cardiac events (death, myocardial infarction, stroke, repeat revascularisation, major bleeding) within 12 months post-randomisation.
Main Results:
- N/A
Conclusions:
- The POLMIDES trial is a prospective, randomized pilot study.
- It aims to determine if HCR is safe, feasible, and efficacious for patients with multivessel CAD undergoing conventional CABG.
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.