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Coronary Artery DiseaseAMI-PONTNCT01585285

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

A study testing LIMA to SVG Bridge Technique and Conventional CABG in people with Coronary Artery Disease, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
LIMA to SVG Bridge Technique and Conventional CABG
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
1 siteCanada
Study dates
Jul 2012to Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

  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.

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:

  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%. Other exclusion criteria precluding MSCT include:
  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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2W1T8

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
LIMA to SVG Bridge Technique, Conventional CABG
Keywords
Coronary artery bypass grafting, Left internal mammary artery, Composite grafting, Multislice Spiral Computed Tomography Scanner, Graft patency assessment
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LIMA to SVG Bridge TechniqueProcedure or surgery

    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 CABGProcedure or surgery

    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

Study groups in NCT01585285
Study groupRoleWhat they receive
LIMA to SVG BridgeExperimentalPatients will receive composite coronary artery bypass grafting (CABG) with left internal mammary artery (LIMA) and saphenous vein graft (SVG) Bridge for the anterolateral targets
Receives: Procedure: LIMA to SVG Bridge Technique
Conventional CABGActive comparatorPatients 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
Receives: Procedure: Conventional CABG

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year

Secondary outcomes (5)

  1. 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

    Measured: 1 and 5 years

  2. 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.

    Measured: 30 days, 1, 5 and 10 years

  3. 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.

    Measured: 30 days, 1, 5 and 10 years

  4. 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.

    Measured: 30 days, 1, 5 and 10 years

  5. 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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionApr 2022
  4. Study completionApr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01585285
Sponsor's protocol ID
CHUM-11-233
Acronym
AMI-PONT
Status last verified
Nov 2022
First submitted
24 Apr 2012
Last updated
16 Nov 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Manuscripts, Abstracts, Presentations

Publications

  • 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.

    PubMed 23971858

  • 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.

    PubMed 23904134

  • 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.

    PubMed 36805638

Questions about this trial

What is this clinical trial studying?

A study testing LIMA to SVG Bridge Technique and Conventional CABG in people with Coronary Artery Disease, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anterolateral territory graft patency index (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01585285, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.

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