An interventional study of LIMA to SVG Bridge Technique and Conventional CABG in Coronary Artery Disease, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-16.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Treatment
The purpose of the AMI-PONT trial is to assess whether the results in term of graft patency with a novel coronary artery bypass (CABG) strategy, including a saphenous vein bridge to distribute the arterial flow of the left anterior mammary artery (LIMA) to all the anterolateral territory, are not inferior than a conventional CABG strategy combining separated LIMA graft to left anterior descending coronary and vein graft for other target vessels of the anterolateral territory.
Purpose: This novel surgical design use a composite-sequential venous graft to distribute left anterior mammary artery (LIMA) inflow directly to the left anterior descending coronary (LAD), but also to the other branches of the anterolateral territory thereby promoting a higher flow through the LIMA pedicle. It is constructed using a short saphenous vein graft (SVG) bridge (LSVB) interposed between the LAD and one (or more) other anterolateral targets, with the LIMA grafted on the hood of the SVG just above the LAD anastomosis.
Objectives. The main objective of the prospective randomized clinical trial AMI-PONT is to assess whether a CABG strategy including a LSVB to distribute the LIMA outflow provides non-inferior patency rates compared to conventional CABG surgery with separated LIMA graft to LAD and SVG to other anterolateral targets.
Methods. Two hundred adult patients undergoing primary isolated CABG, requiring grafting of LAD and at least one other anterolateral target, will be randomized 1:1 in two treatment arms: 1) CABG strategy with LSVB; and 2) conventional CABG strategy with LIMA graft to the LAD and separate aorto-coronary SVG to other anterolateral targets. Patients will be assessed clinically at 30 days, 6 months, one, five and ten years. They will undergo graft patency assessment at one and five years using Multi-Slice Computed Tomography. All patients will undergo CABG using cardiopulmonary bypass (CPB). Patients will be excluded if they have a contraindication to CPB or MSCT graft assessment.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 208 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
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Inclusion Criteria: Patients who undergo coronary artery bypass grafting (CABG) surgery (for single, double or triple vessel disease) will be eligible if they:
Exclusion Criteria: A patient will be excluded from the study if he/she does not fulfill the inclusion criteria, the patient or the treating physician refuse the study or if any of the following are observed:
severe congestive heart failure with left ventricular ejection fraction less than 30%.
Other exclusion criteria precluding MSCT include:
pregnant/lactating female.
Furthermore, patients may be excluded at the time of MSCT if they are:
Patients will receive composite coronary artery bypass grafting (CABG) with left internal mammary artery (LIMA) and saphenous vein graft (SVG) Bridge for the anterolateral targets
Procedure: LIMA to SVG Bridge Technique
Patients will receive conventional coronary artery bypass grafting (CABG) with left internal mammary artery (LIMA) graft to the left anterior descending (LAD) and separate sequential aorto-coronary saphenous vein grafts (SVG) to the others anterolateral targets
Procedure: Conventional CABG
This surgical design use a composite-sequential venous graft to distribute left internal mammary artery (LIMA) inflow directly to the left anterior descending (LAD), but also to the other branches of the anterolateral territory thereby promoting a higher flow through the LIMA pedicle. It is constructed using a short saphenous vein graft (SVG) bridge interposed between the LAD and one (or more) other anterolateral targets, with the LIMA grafted on the hood of the SVG just above the LAD anastomosis.
Conventional coronary artery bypass grafting (CABG) strategy with left internal mammary artery (LIMA) graft to the left anterior descending (LAD) and separate sequential aorto-coronary saphenous vein grafts (SVG) to the others anterolateral targets
Anterolateral territory graft patency index
Proportion of patent (non-occluded) distal anastomoses out of the total number of distal anastomoses for anterolateral distribution including the LAD and the other anterolateral territory coronary target assessed by multi-slice computed tomography angiography for all patients
Time frame: 1 year
Assessment of grafts patency taken separately
LIMA to LAD graft patency will be specifically assessed in both groups. Since the grafting strategy provides direct perfusion of the LAD by anastomosing on the hood of the SVG anastomosis to the LAD, we do not expect to see a difference between groups for the expected superior LIMA-LAD patency
Time frame: 1 and 5 years
Composite clinical outcome
Occurrence of the composite outcome of total mortality, nonfatal myocardial infarction, or target vessel revascularization (i.e. redo CABG surgery or percutaneous coronary intervention). Each clinical outcome will also be assessed separately.
Time frame: 30 days, 1, 5 and 10 years
Cardiovascular mortality
Cardiovascular (CV) mortality: all deaths after the first 30 days are considered CV deaths unless a specific non-cardiovascular cause is evident and considered to be the cause of death (e.g. malignancy). Furthermore, patients who die during the index hospitalization but after the initial 30 days period (i.e. long ICU stay with sepsis) will be considered as CV deaths.
Time frame: 30 days, 1, 5 and 10 years
Recurrence of angina
Recurrence of angina: new onset of typical chest angina with documented ischemia by stress testing (ECG, echocardiography, or nuclear) or persistence of CCS grade ≥2 angina after surgery.
Time frame: 30 days, 1, 5 and 10 years
Anterolateral territory graft patency index
Proportion of patent (non-occluded) distal anastomoses out of the total number of distal anastomoses for anterolateral distribution including the LAD and the other anterolateral territory coronary target assessed by multi-slice computed tomography angiography for all patients
Time frame: 5 years
Plan to share: Yes — Manuscripts, Abstracts, Presentations
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Centre hospitalier de l'Université de Montréal (CHUM)