Clinical trial NCT01585285: Coronary Artery Bypass Grafting Strategies for the Anterolateral Territory: a Prospective Randomized Clinical Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary artery bypass grafting
Left internal mammary artery
Composite grafting
Multislice Spiral Computed Tomography Scanner
Graft patency assessment
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2012-04-25
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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.

Primary outcomes:
measure: Anterolateral territory graft patency index
timeFrame: 1 year
Secondary outcomes:
measure: Assessment of grafts patency taken separately
timeFrame: 1 and 5 years
measure: Composite clinical outcome
timeFrame: 30 days, 1, 5 and 10 years
measure: Cardiovascular mortality
timeFrame: 30 days, 1, 5 and 10 years
measure: Recurrence of angina
timeFrame: 30 days, 1, 5 and 10 years
measure: Anterolateral territory graft patency index
timeFrame: 5 years
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal (CHUM)
state: Quebec
Study officials:
affiliation: Centre Hospitalier de l'Universite de Montreal (CHUM)
name: Louis-Mathieu Stevens, MD, PhD (c)
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.