Composite versus conventional coronary artery bypass grafting strategy for the anterolateral territory: study protocol for a randomized controlled trial

Trials

Louis-Mathieu Stevens²  Ignacio Prieto¹  Fadi Basile¹  Jan-Alexis Tremblay¹  Samer Mansour²  Gilles Soulez²  Carl Chartrand-Lefebvre²  Nicolas Noiseux²  Ariane Drouin¹ 

[1] Division of Cardiac Surgery, 3840, Saint-Urbain Street, Montreal, Quebec, H2W 1T8, Canada;Centre hospitalier de l’Université de Montréal (CHUM), CHUM Research Centre (CRCHUM), 3840, Saint-Urbain Street, Montreal, Quebec, H2W 1T8, Canada

关键词: Saphenous vein graft;    Randomized clinical non-inferiority trial;    Multislice computed tomography angiography;    Long-term follow-up;    Left internal mammary artery;    Ischemic heart disease;    Doppler velocimetry;    Coronary artery bypass grafting;    Composite graft;    Cardiopulmonary bypass;   

Others  :  1093172
DOI  :  10.1186/1745-6215-14-270

 received in 2013-07-08, accepted in 2013-08-12,  发布年份 2013

【 摘 要 】

Background

In severe coronary artery disease, coronary artery bypass grafting (CABG) surgery is indicated to re-establish an adequate blood supply to the ischemic myocardium. Effectiveness of CABG surgery for symptom relief and mortality decrease should therefore depend on bypass graft patency. As bypass using a left internal mammary artery (LIMA)-to-left anterior descending coronary artery (LAD) anastomosis allows the best results in terms of graft patency, we designed a new surgical technique using a saphenous vein graft as a venous bridge to distribute the LIMA flow to the cardiac anterolateral territory. This novel strategy could extend the patency benefits associated to the LIMA. Other potential benefits of this technique include easier surgical technique, possibility to use saphenous vein grafts as vein patch angioplasty, shorter saphenous vein grafts requirement and reduced or eliminated manipulations of the ascendant aorta (and associated stroke risk).

Methods/Design

Between July 2012 and 2016, 200 patients undergoing a primary isolated CABG surgery using cardiopulmonary bypass with a LAD bypass graft and at least another target on the anterolateral territory will be randomized (1:1) according to 1) the new composite strategy and 2) the conventional strategy with a LIMA-to-LAD anastomosis and revascularization of the other anterolateral target(s) with a separated aorto-coronary saphenous vein graft. The primary objective of the trial is to assess whether the composite strategy allows non-inferior anterolateral graft patency index (proportion of non-occluded CABGs out of the total number of CABGs) compared to the conventional technique. The primary outcome is the anterolateral graft patency index, evaluated at one year by 256-slice computed tomography angiography. Ten years of clinical follow-up is planned to assess clinical outcomes including death, myocardial infarction and need for revascularization.

Discussion

This non-inferiority trial has the potential to advance the adult cardiac surgery field, given the potential benefits associated with the composite grafting strategy.

Trial registration

ClinicalTrials.gov: NCT01585285.

【 授权许可】

   
2013 Drouin et al.; licensee BioMed Central Ltd.

【 图 表 】

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