Clinical trial NCT03217006: Randomization of Single vs Multiple Arterial Grafts
Official title: Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts: the ROMA Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Heart Diseases
Keywords: coronary artery bypass surgery
multiple arterial graft
radial artery graft
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Canadian Institutes of Health Research (CIHR)
First posted: 2017-07-13
Enrollment: 4300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Composite Outcome
timeFrame: > 72 hours after surgery and/or repeat revascularization
Secondary outcomes:
measure: 30-day mortality
timeFrame: 30 days post-operatively
measure: Major postoperative complications
timeFrame: In-hospital stay, up to 30 days post-operatively
measure: Sternal wound complication
timeFrame: 6 months post-operatively
measure: Composite Outcome of Death from any cause
timeFrame: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years.
measure: Stroke
timeFrame: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years.
measure: Cause-specific death (cardiac vs non-cardiac)
timeFrame: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years
measure: Hospital readmissions
timeFrame: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado
state: Colorado
city: Springfield
country: United States
facility: Baystate Health
state: Massachusetts
city: Lincoln
country: United States
facility: Nebraska Heart Hospital
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Brooklyn
country: United States
facility: NewYork-Presbyterian Brooklyn Methodist Hospital
state: New York
city: New York
country: United States
facility: Icahn School of Medicine, Mount Sinai
state: New York
city: New York
country: United States
facility: Weil Cornell Medical College Department of Cardiothoracic Surgery
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital (Northwell)
state: New York
city: New York
country: United States
facility: NewYork-Presbyterian Queens
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny General Hospital (Cardiovascular Institute)
state: Pennsylvania
city: Innsbruck
country: Austria
facility: Innsbruck (Medical University) Austria
city: Vienna
country: Austria
facility: Krankenhaus Nord Vienna North Hospital
city: Vienna
country: Austria
facility: MU Vienna Austria
city: São Paulo
country: Brazil
facility: Federal University of Sao Paulo
city: Hamilton
country: Canada
facility: Hamilton General Hospital
city: London
country: Canada
facility: London Health Sciences Ontario Canada
city: Montréal
country: Canada
facility: University Hospital of Montreal (CHUM)
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute Canada
city: Quebec
country: Canada
facility: Royal Victoria Hospital (McGill)
city: Quebec
country: Canada
facility: Universite Laval Quebec (CRIUCPQ) Canada
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
city: Toronto
country: Canada
facility: Toronto General Hospital
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital / WHRA
city: Beijing
country: China
facility: Fuwai Hospital
city: Changchun
country: China
facility: Jilin Heart Hospital
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University School of Medicine
city: Taiwan
country: China
facility: National Taiwan University Hospital
city: Tianjin
country: China
facility: Teda Hospital (TICH)
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
city: Prague
country: Czechia
facility: General University Hospital, Prague
city: Duisburg
country: Germany
facility: Duisburg Heart Center
city: Duisburg
country: Germany
facility: Essen University
city: Düsseldorf
country: Germany
facility: Düsseldorf University
city: Erlangen
country: Germany
facility: University Hospital Erlangen
city: Giessen
country: Germany
facility: Giessen Hospital
city: Göttingen
country: Germany
facility: University Medical Center of Goettingen
city: Jena
country: Germany
facility: Jena University Hospital
city: Leipzig
country: Germany
facility: Heart Center (Herzzentrum)
city: Oeynhausen
country: Germany
facility: HDZ NRW Bad
city: Stuttgart
country: Germany
facility: Robert-Bosch-Hospital
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier
city: Bari
country: Italy
facility: Anthea Hospital
city: Brescia
country: Italy
facility: Fondazione Poliambulanza
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital GVM
city: Roma
country: Italy
facility: Universita' Cattolica del Sacro Cuore
city: Rome
country: Italy
facility: European Hospital
city: Torino
country: Italy
facility: Ospedale Le Molinette
city: Saitama
country: Japan
facility: Saitama Medical University
city: Sinchŏn-dong
country: Korea, Republic of
facility: Severance Cardiovascular Hospital, Yonsei University College of Medicine
city: Maastricht
country: Netherlands
facility: MUMC Maastricht (University Medical Centre)
city: Katowice
country: Poland
facility: Medical University of Silesia (Katowice)
city: Capuchos
country: Portugal
facility: Hospitalar de Lisboa Central
city: Coimbra
country: Portugal
facility: University Hospital (Praceta Mota Pinto)
city: Porto
country: Portugal
facility: Centro Hospitalar e Universitário São João
city: Belgrade
country: Serbia
facility: Dedinje Cardiovascular Institute
city: Singapore
country: Singapore
facility: National University of Singapore
city: Alicante
country: Spain
facility: Hospital Univeritario Del Vinalopo
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona (ICCV)
Study officials:
affiliation: Weill Medical College of Cornell University
name: Mario Gaudino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Stephen Fremes, MD
role: PRINCIPAL_INVESTIGATOR
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