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

NCT01585285 | Completed DMC

• 1 other identifier: CHUM-11-233
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Coronary artery bypass grafting; Left internal mammary artery; Composite grafting; Multislice Spiral Computed Tomography Scanner; Graft patency assessment

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (5)

• Assessment of grafts patency taken separately

  1 and 5 years

• Composite clinical outcome

  30 days, 1, 5 and 10 years

• Cardiovascular mortality

  30 days, 1, 5 and 10 years

• Recurrence of angina

  30 days, 1, 5 and 10 years

• Anterolateral territory graft patency index

  5 years

Study Arms (2)

LIMA to SVG Bridge

EXPERIMENTAL

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

Conventional CABG

ACTIVE COMPARATOR

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

Interventions

LIMA to SVG Bridge Technique 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.

LIMA to SVG Bridge

Conventional CABG 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

Conventional CABG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• require isolated CABG with median sternotomy on at least one left anterior descending (LAD) site and another anterolateral target;
• provide written informed consent;
• are more than 21 years of age.

You may not qualify if:

• concomitant cardiac procedure associated with CABG including valve surgery and ascending aorta surgery;
• contra-indications to cardiopulmonary bypass (calcified aorta);
• 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;
• concomitant life-threatening disease likely to limit life expectancy to less than 2 years;
• emergency CABG surgery (immediate revascularization for hemodynamic instability precluding patient consent);
• prior CABG;
• severe congestive heart failure with left ventricular ejection fraction less than 30%.
• moderate to severe renal impairment (estimated glomerular filtration rate, eGFR \<50 mL/min/1.73 m2);
• chronic atrial fibrillation (which can preclude ECG-gating during MSCT);
• history of severe hypersensitivity to iodinated contrast agents;
• known or suspected for pheochromocytoma;
• pregnant/lactating female.
• Furthermore, patients may be excluded at the time of MSCT if they are:
• in persistent rapid (\>100/min) atrial fibrillation or any other cardiac rhythm that precludes reliable ECG triggering;
• severe congestive heart failure, New York Heart Association (NYHA) Class IV, despite coronary revascularization and maximal medical treatment.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, H2W1T8, Canada

Location

Related Publications (3)

• 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.

  PMID: 23971858 BACKGROUND

• 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.

  PMID: 23904134 BACKGROUND

• 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.

  PMID: 36805638 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Louis-Mathieu Stevens, MD, PhD (c)

  Centre Hospitalier de l'Universite de Montreal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: April 25, 2012
• Study Start: July 1, 2012
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: The study was presented at the EACTS meeting in Milan Oct 2022
• Access Criteria: Access to Journal

Locations

CA (1)