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

Ariane Drouin, Nicolas Noiseux, Carl Chartrand-Lefebvre, Gilles Soulez, Samer Mansour, Jan-Alexis Tremblay, Fadi Basile, Ignacio Prieto, Louis-Mathieu Stevens, Ariane Drouin, Nicolas Noiseux, Carl Chartrand-Lefebvre, Gilles Soulez, Samer Mansour, Jan-Alexis Tremblay, Fadi Basile, Ignacio Prieto, Louis-Mathieu Stevens

Abstract

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.

Figures

Figure 1
Figure 1
Study design. CABG, coronary artery bypass grafting; CPB, cardiopulmonary bypass; LIMA, left internal mammary artery; MSCT, multislice computed tomography.
Figure 2
Figure 2
Conventional strategy. The in situ left internal mammary artery is directly anastomosed to the left anterior descending coronary artery (LAD) and a separated aorto-coronary saphenous vein graft is anastomosed to the anterolateral target(s) other than the LAD. A magnified detail of the distal anastomoses is provided in the left upper corner of the figure. The distal portion of the left internal mammary artery (LIMA) pedicle has been graphically removed in order to present a better view of the distal anastomosis. SVG, saphenous vein graft.
Figure 3
Figure 3
Left internal mammary artery-saphenous vein bridge strategy. The in situ left internal mammary artery (LIMA) and a saphenous vein bridge are used compositely to distribute the LIMA flow to the anterolateral territory. A magnified detail of the distal anastomoses is provided in the left upper corner of the figure. The distal portion of the LIMA pedicle has been graphically removed in order to present a better view of the distal anastomosis. LAD, left anterior descending coronary artery; SV, saphenous vein.
Figure 4
Figure 4
Possible trial outcomes. Potential study outcomes are presented with point estimate for the difference in anterolateral graft patency index between the two study groups with a 95% confidence interval for the difference. See text for details. CABG, coronary artery bypass grafting.

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