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Randomization of Single vs Multiple Arterial Grafts (ROMA)

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ClinicalTrials.gov Identifier: NCT03217006
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : May 23, 2019
Sponsor:
Collaborators:
Sunnybrook Health Sciences Centre
Duke University
The Cleveland Clinic
Heart Center Leipzig - University Hospital
University of Rotterdam, The Netherlands
Maastricht University Medical Center
University College Hospital Galway
Ottawa Heart Institute Research Corporation
University of Toledo Health Science Campus
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:

The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival.

Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects enrolled in at least 25 international centers. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1 fashion between the two groups. Permuted block randomization with random blocks stratified by the center and the type of second arterial graft will be used to provide treatment distribution in equal proportion.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Heart Diseases Procedure: Single arterial graft Procedure: Multiple arterial grafting Not Applicable

Detailed Description:

In the 1980's, it was recognized that long-term survival was enhanced in patients undergoing coronary surgery when the left anterior descending (LAD) was grafted with a left internal thoracic artery (ITA) rather than a saphenous vein (1). This difference was predicated, at least in part, due to greater and more durable patency of the left ITA compared to an increased early occlusion rate and later progressive atherosclerosis of saphenous vein grafts (SVG) (2).

For more than 20 years it has generally been accepted that patients who receive multiple arterial grafts (AGs) at the time of coronary artery bypass surgery (CABG) have increased postoperative survival compared to those who receive only one AG, especially over the long term (3-5). The current United States and European Guidelines encourage the use of AGs in patients with a long life expectancy (6, 7). Last year, a position paper from the Society of Thoracic Surgeons strongly recommended a wider use of AGs (8).

The putative mechanism underlying the AG hypothesis is greater patency. In line with the original findings of improved LAD graft patency with ITA vs. SVG, data from randomized control trials (RCTs) as well as observational studies and a network meta-analysis (9) have demonstrated that the patency of the RA, as well as the right ITA, exceed that of a SVG, providing mechanistic basis to support the AG hypothesis.

ROMA is a two arm event driven randomized multi-centre trial aimed at evaluating the impact of the use of one ITA vs two or more AGs for CABG on a composite of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The trial is powered to detect a 20% relative reduction in the primary outcome with 90% power at 5% alpha.

The primary aim is to conduct a multicenter international randomized control trial to test the hypothesis that the use of a two or more AGs compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization.

The secondary aim is to conduct a multicenter international randomized control trial to test the hypothesis that the use of two or more AGs compared to a single arterial graft is associated with improved survival.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients undergoing coronary artery bypass surgery will be in one of two groups. One group will receive a single arterial graft and the second group will receive two or more arterial grafts.
Masking: Single (Outcomes Assessor)
Masking Description: The endpoint assessors will be blinded to treatment allocation (PROBE).
Primary Purpose: Treatment
Official Title: Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts: the ROMA Trial
Actual Study Start Date : January 7, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : January 1, 2030

Arm Intervention/treatment
Experimental: Single Arterial Group
Patients in this group will receive a single arterial graft which will be the left internal thoracic artery. Additional grafts used in this group will all be venous grafts.
Procedure: Single arterial graft
This interventions consists of patients receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. In addition to the left internal thoracic artery patients will receive venous grafts for all additional grafting.

Experimental: Multiple Arterial Group
Patients in the group will receive multiple arterial grafts. All patients will receive at least two arterial grafts, the left internal thoracic artery with the addition of either the right internal thoracic artery or the radial artery as the second conduit. Some patients may receive additional arterial grafts consisting of the radial artery, the right internal thoracic artery, or the right gastroepiploic artery.
Procedure: Multiple arterial grafting
This intervention consists of the patient receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. The second arterial graft (right internal thoracic artery or radial artery) will be directed to the major branch of the circumflex. Additional grafts will include saphenous veins or arterial conduits.




Primary Outcome Measures :
  1. Composite Outcome [ Time Frame: Analysis will be performed after 845 events. The investigators assume this will occur at a mean follow-up of 5 years ]
    A composite of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization.


Secondary Outcome Measures :
  1. Primary Secondary Outcome (Overall mortality) [ Time Frame: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 10 years ]
    All cause mortality

  2. Major postoperative complications [ Time Frame: In-hospital stay, up to 30 days post-operatively ]
    Revision for bleeding, perioperative myocardial infarction, any stroke, need for dialysis, need for tracheostomy, and surgical site infection.

  3. Composite Outcome [ Time Frame: Analysis will be performed after 845 events. The investigators assume this will occur at a mean follow-up of 5 years ]
    A composite of death from any cause, post discharge myocardial infarction, and/or repeat revascularization.

  4. Composite Outcome [ Time Frame: Analysis will be performed after 845 events. The investigators assume this will occur at a mean follow-up of 5 years. ]
    A composite of death from any cause, any stroke, any myocardial infarction, and/or repeat revascularization

  5. Stroke [ Time Frame: Analysis will be performed after 845 events. The investigators assume this will occur at a mean follow-up of 5 years. ]
    Any stroke

  6. Post-operative myocardial infarct [ Time Frame: Up to 30 days post-operatively ]
    Any post-operative myocardial infarct

  7. Repeat revascularization [ Time Frame: Analysis will be performed after 845 events. The investigators assume this will occur at a mean follow-up of 5 years. ]
    Any post-operative repeat revascularization

  8. Cause specific mortality [ Time Frame: Analysis will be performed after 845 events. The investigators assume this will occur at a mean follow-up of 5 years ]
    Death as either cardiac or non-cardiac in etiology

  9. 30-day mortality [ Time Frame: 30 days ]
    Death from any cause at 30-days

  10. Harvest site complications [ Time Frame: 6 months ]
    Any complication directly related to the harvest site



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary isolated CABG patients with disease of the left main coronary artery and/or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.

Exclusion Criteria:

  • Age > 70 years
  • Single graft
  • Emergency operation
  • Evolving myocardial infarction within 48 hours of surgery
  • Left ventricular ejection fraction of < 35%
  • Any concomitant cardiac or non-cardiac procedure
  • Previous cardiac surgery
  • Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any co-morbidity that reduce life expectancy to less than 5 years.
  • Inability to use the saphenous vein or to use both radial and right internal thoracic arteries
  • Anticipated need for coronary thrombo-endarterectomy
  • Planned hybrid revascularization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03217006


Contacts
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Contact: Mario Gaudino, MD 212.746.1812 mfg9004@med.cornell.edu
Contact: Renee Aviv (212) 746-5194 rek9015@med.cornell.edu

Locations
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United States, New York
Weil Cornell Medical College Department of Cardiothoracic Surgery Recruiting
New York, New York, United States, 10065
Contact: Mario F Gaudino, MD    212-746-1815    mfg9004@med.cornell.edu   
Contact: Nathan T Palaparthi, MS    212-746-5194    ntp2001@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Sunnybrook Health Sciences Centre
Duke University
The Cleveland Clinic
Heart Center Leipzig - University Hospital
University of Rotterdam, The Netherlands
Maastricht University Medical Center
University College Hospital Galway
Ottawa Heart Institute Research Corporation
University of Toledo Health Science Campus
Investigators
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Principal Investigator: Mario Gaudino, MD Weill Cornell Medicine
Principal Investigator: Stephen Fremes, MD Sunnybrook Health Sciences Centre

Publications:

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03217006     History of Changes
Other Study ID Numbers: 1703018094
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Weill Medical College of Cornell University:
coronary artery bypass surgery
multiple arterial graft
radial artery graft

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases