Randomization of Single vs Multiple Arterial Grafts
- Conditions
- Coronary Artery DiseaseHeart Diseases
- Interventions
- Procedure: Multiple arterial graftingProcedure: Single arterial graft
- Registration Number
- NCT03217006
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 4300
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multiple Arterial Group Multiple arterial grafting 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. Single Arterial Group Single arterial graft 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.
- Primary Outcome Measures
Name Time Method Composite Outcome > 72 hours after surgery and/or repeat revascularization A composite of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization.
- Secondary Outcome Measures
Name Time Method 30-day mortality 30 days post-operatively Death from any cause at 30-days
Stroke Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years. Post discharge myocardial infarction and repeat revascularization considered as individual events
Cause-specific death (cardiac vs non-cardiac) Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years Death as either cardiac or non-cardiac in etiology
Major postoperative complications 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.
Sternal wound complication 6 months post-operatively Wound drainage, skin separation, unstable sternum, and sternal dehiscence, infection
Composite Outcome of Death from any cause Analysis will be performed after 631 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,stroke, and/or repeat revascularization
Hospital readmissions Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years Hospital readmissions with specific causes
Trial Locations
- Locations (59)
University Hospital Erlangen
🇩🇪Erlangen, Germany
Heart Center (Herzzentrum)
🇩🇪Leipzig, Germany
Robert-Bosch-Hospital
🇩🇪Stuttgart, Germany
Krankenhaus der Barmherzigen Brüder Trier
🇩🇪Trier, Germany
Ospedale Le Molinette
🇮🇹Torino, Italy
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Allegheny General Hospital (Cardiovascular Institute)
🇺🇸Pittsburgh, Pennsylvania, United States
MU Vienna Austria
🇦🇹Vienna, Austria
Dedinje Cardiovascular Institute
🇷🇸Belgrade, Serbia
Krankenhaus Nord Vienna North Hospital
🇦🇹Vienna, Austria
Hospitalar de Lisboa Central
🇵🇹Capuchos, Portugal
University of Colorado
🇺🇸Boulder, Colorado, United States
Innsbruck (Medical University) Austria
🇦🇹Innsbruck, Austria
University Hospital (Praceta Mota Pinto)
🇵🇹Coimbra, Portugal
Centro Hospitalar e Universitário São João
🇵🇹Porto, Portugal
Baystate Health
🇺🇸Springfield, Massachusetts, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Nebraska Heart Hospital
🇺🇸Lincoln, Nebraska, United States
NewYork-Presbyterian Brooklyn Methodist Hospital
🇺🇸Brooklyn, New York, United States
Weil Cornell Medical College Department of Cardiothoracic Surgery
🇺🇸New York, New York, United States
Icahn School of Medicine, Mount Sinai
🇺🇸New York, New York, United States
Lenox Hill Hospital (Northwell)
🇺🇸New York, New York, United States
NewYork-Presbyterian Queens
🇺🇸New York, New York, United States
Federal University of Sao Paulo
🇧🇷São Paulo, Brazil
Hamilton General Hospital
🇨🇦Hamilton, Canada
London Health Sciences Ontario Canada
🇨🇦London, Canada
University Hospital of Montreal (CHUM)
🇨🇦Montréal, Canada
University of Ottawa Heart Institute Canada
🇨🇦Ottawa, Canada
Royal Victoria Hospital (McGill)
🇨🇦Quebec, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Canada
Universite Laval Quebec (CRIUCPQ) Canada
🇨🇦Quebec, Canada
St. Boniface General Hospital / WHRA
🇨🇦Winnipeg, Canada
Toronto General Hospital
🇨🇦Toronto, Canada
Jilin Heart Hospital
🇨🇳Changchun, China
Fuwai Hospital
🇨🇳Beijing, China
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
University Hospital Dubrava
🇭🇷Zagreb, Croatia
Teda Hospital (TICH)
🇨🇳Tianjin, China
National Taiwan University Hospital
🇨🇳Taiwan, China
General University Hospital, Prague
🇨🇿Prague, Czechia
Duisburg Heart Center
🇩🇪Duisburg, Germany
Essen University
🇩🇪Duisburg, Germany
Düsseldorf University
🇩🇪Düsseldorf, Germany
University Medical Center of Goettingen
🇩🇪Göttingen, Germany
Jena University Hospital
🇩🇪Jena, Germany
Giessen Hospital
🇩🇪Giessen, Germany
HDZ NRW Bad
🇩🇪Oeynhausen, Germany
Fondazione Poliambulanza
🇮🇹Brescia, Italy
Universita' Cattolica del Sacro Cuore
🇮🇹Roma, Italy
Anthea Hospital
🇮🇹Bari, Italy
European Hospital
🇮🇹Rome, Italy
Maria Cecilia Hospital GVM
🇮🇹Cotignola, Italy
Saitama Medical University
🇯🇵Saitama, Japan
Severance Cardiovascular Hospital, Yonsei University College of Medicine
🇰🇷Sinchŏn-dong, Korea, Republic of
MUMC Maastricht (University Medical Centre)
🇳🇱Maastricht, Netherlands
Medical University of Silesia (Katowice)
🇵🇱Katowice, Poland
Hospital Univeritario Del Vinalopo
🇪🇸Alicante, Spain
Hospital Clinic de Barcelona (ICCV)
🇪🇸Barcelona, Spain
National University of Singapore
🇸🇬Singapore, Singapore