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Coronary Artery Bypass Grafting Strategies for the Anterolateral Territory: a Prospective Randomized Clinical Trial (AMI-PONT)

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

LIMA to SVG Bridge Technique

Conventional CABG

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery bypass grafting, Left internal mammary artery, Composite grafting, Multislice Spiral Computed Tomography Scanner, Graft patency assessment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who undergo coronary artery bypass grafting (CABG) surgery (for single, double or triple vessel disease) will be eligible if they:

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.

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:

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%.
Other exclusion criteria precluding MSCT include:
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.

Sites / Locations

Centre Hospitalier de l'Universite de Montreal (CHUM)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LIMA to SVG Bridge

Conventional CABG

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

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.

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.

Anterolateral territory graft patency index

Full Information

NCT ID

NCT01585285

First Posted

April 24, 2012

Last Updated

November 11, 2022

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT01585285

Brief Title

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

Acronym

AMI-PONT

Official Title

Composite Arterial and Venous Grafting Strategy Versus Conventional Coronary Artery Bypass Grafting for the Anterolateral Territory: a Prospective Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

April 2022 (Actual)

Study Completion Date

April 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

208 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LIMA to SVG Bridge

Arm Type

Experimental

Arm Description

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

Arm Title

Conventional CABG

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

LIMA to SVG Bridge Technique

Intervention Description

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

Intervention Name(s)

Conventional CABG

Intervention Description

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

Primary Outcome Measure Information:

Title

Anterolateral territory graft patency index

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Assessment of grafts patency taken separately

Description

Time Frame

1 and 5 years

Title

Composite clinical outcome

Description

Time Frame

30 days, 1, 5 and 10 years

Title

Cardiovascular mortality

Description

Time Frame

30 days, 1, 5 and 10 years

Title

Recurrence of angina

Description

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

Title

Anterolateral territory graft patency index

Description

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who undergo coronary artery bypass grafting (CABG) surgery (for single, double or triple vessel disease) will be eligible if they: 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. 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: 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%. Other exclusion criteria precluding MSCT include: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Louis-Mathieu Stevens, MD, PhD (c)

Organizational Affiliation

Centre Hospitalier de l'Universite de Montreal (CHUM)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier de l'Universite de Montreal (CHUM)

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W1T8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Manuscripts, Abstracts, Presentations

IPD Sharing Time Frame

The study was presented at the EACTS meeting in Milan Oct 2022

IPD Sharing Access Criteria

Access to Journal

Citations:

PubMed Identifier

23971858

Citation

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.

Results Reference

background

PubMed Identifier

23904134

Citation

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.

Results Reference

background

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

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