Coronary Artery Bypass Grafting Strategies for the Anterolateral Territory: a Prospective Randomized Clinical Trial

NCT ID: NCT01585285

Last Updated: 2022-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2022-04-30

Brief Summary

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.

Detailed Description

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LIMA to SVG Bridge

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

Group Type: EXPERIMENTAL

LIMA to SVG Bridge Technique

Intervention Type: PROCEDURE

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 CABG

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

Group Type: ACTIVE_COMPARATOR

Conventional CABG

Intervention Type: PROCEDURE

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

Interventions

LIMA to SVG Bridge Technique

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.

Intervention Type: PROCEDURE

Conventional CABG

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. require isolated CABG with median sternotomy on at least one left anterior descending (LAD) site and another anterolateral target;

2. provide written informed consent;

3. are more than 21 years of age.

1. concomitant cardiac procedure associated with CABG including valve surgery and ascending aorta surgery;

2. contra-indications to cardiopulmonary bypass (calcified aorta);

3. unusable left internal mammary artery (LIMA) such as uncorrected subclavian artery stenosis, anterior chest trauma, radiation or injury during harvesting precluding the use of the LIMA;

4. concomitant life-threatening disease likely to limit life expectancy to less than 2 years;

5. emergency CABG surgery (immediate revascularization for hemodynamic instability precluding patient consent);

6. prior CABG;

7. severe congestive heart failure with left ventricular ejection fraction less than 30%.

Exclusion Criteria

8. moderate to severe renal impairment (estimated glomerular filtration rate, eGFR <50 mL/min/1.73 m2);

9. chronic atrial fibrillation (which can preclude ECG-gating during MSCT);

10. history of severe hypersensitivity to iodinated contrast agents;

11. known or suspected for pheochromocytoma;

12. pregnant/lactating female.

Furthermore, patients may be excluded at the time of MSCT if they are:

13. in persistent rapid (>100/min) atrial fibrillation or any other cardiac rhythm that precludes reliable ECG triggering;

14. severe congestive heart failure, New York Heart Association (NYHA) Class IV, despite coronary revascularization and maximal medical treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louis-Mathieu Stevens, MD, PhD (c)

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de l'Universite de Montreal (CHUM)

Locations

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Countries

Canada

References

Drouin A, Noiseux N, Chartrand-Lefebvre C, Soulez G, Mansour S, Tremblay JA, Basile F, Prieto I, Stevens LM. Composite versus conventional coronary artery bypass grafting strategy for the anterolateral territory: study protocol for a randomized controlled trial. Trials. 2013 Aug 26;14:270. doi: 10.1186/1745-6215-14-270.

Reference Type: BACKGROUND

PMID: 23971858 (View on PubMed)

Tremblay JA, Stevens LM, Chartrand-Lefebvre C, Chandonnet M, Mansour S, Soulez G, Prieto I, Basile F, Noiseux N. A novel composite coronary bypass graft strategy: the saphenous vein bridge--a pilot study. Eur J Cardiothorac Surg. 2013 Oct;44(4):e302-7. doi: 10.1093/ejcts/ezt388. Epub 2013 Jul 31.

Reference Type: BACKGROUND

PMID: 23904134 (View on PubMed)

Stevens LM, Chartrand-Lefebvre C, Mansour S, Beland V, Soulez G, Forcillo J, Basile F, Prieto I, Noiseux N. Anterolateral territory coronary artery bypass grafting strategies: a non-inferiority randomized clinical trial: the AMI-PONT trial. Eur J Cardiothorac Surg. 2023 Apr 3;63(4):ezad060. doi: 10.1093/ejcts/ezad060.

Reference Type: DERIVED

PMID: 36805638 (View on PubMed)

Other Identifiers

CHUM-11-233

Identifier Type: -

Identifier Source: org_study_id