Randomization of Single vs Multiple Arterial Grafts

Description

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.

Interventions

• Single arterial graft (Procedure)
  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.
• Multiple arterial grafting (Procedure)
  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.

Eligibility criteria

Conditions

Locations

• University of Colorado — Boulder, Colorado, United States
• Baystate Health — Springfield, Massachusetts, United States
• Nebraska Heart Hospital — Lincoln, Nebraska, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• NewYork-Presbyterian Brooklyn Methodist Hospital — Brooklyn, New York, United States
• Icahn School of Medicine, Mount Sinai — New York, New York, United States
• Weil Cornell Medical College Department of Cardiothoracic Surgery — 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
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Allegheny General Hospital (Cardiovascular Institute) — Pittsburgh, Pennsylvania, United States
• Innsbruck (Medical University) Austria — Innsbruck, Austria
• Krankenhaus Nord Vienna North Hospital — Vienna, Austria
• MU Vienna Austria — Vienna, Austria
• 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) — Montreal, Canada
• University of Ottawa Heart Institute Canada — Ottawa, Canada
• Royal Victoria Hospital (McGill) — Québec, Canada
• Universite Laval Quebec (CRIUCPQ) Canada — Québec, Canada
• Sunnybrook Health Sciences Centre — Toronto, Canada
• Toronto General Hospital — Toronto, Canada
• St. Boniface General Hospital / WHRA — Winnipeg, Canada
• Fuwai Hospital — Beijing, China
• Jilin Heart Hospital — Changchun, China
• Ruijin Hospital Shanghai Jiao Tong University School of Medicine — Shanghai, China
• National Taiwan University Hospital — Taiwan, China
• Teda Hospital (TICH) — Tianjin, China
• University Hospital Dubrava — Zagreb, Croatia
• General University Hospital, Prague — Prague, Czechia
• Duisburg Heart Center — Duisburg, Germany
• Essen University — Duisburg, Germany
• Düsseldorf University — Düsseldorf, Germany
• University Hospital Erlangen — Erlangen, Germany
• Giessen Hospital — Giessen, Germany
• University Medical Center of Goettingen — Göttingen, Germany
• Jena University Hospital — Jena, Germany
• Heart Center (Herzzentrum) — Leipzig, Germany
• HDZ NRW Bad — Oeynhausen, Germany
• Robert-Bosch-Hospital — Stuttgart, Germany
• Krankenhaus der Barmherzigen Brüder Trier — Trier, Germany
• Anthea Hospital — Bari, Italy
• Fondazione Poliambulanza — Brescia, Italy
• Maria Cecilia Hospital GVM — Cotignola, Italy
• Universita' Cattolica del Sacro Cuore — Roma, Italy
• European Hospital — Rome, Italy
• Ospedale Le Molinette — Torino, Italy
• Saitama Medical University — Saitama, Japan
• MUMC Maastricht (University Medical Centre) — Maastricht, Netherlands
• Medical University of Silesia (Katowice) — Katowice, Poland
• Hospitalar de Lisboa Central — Capuchos, Portugal
• University Hospital (Praceta Mota Pinto) — Coimbra, Portugal
• Centro Hospitalar e Universitário São João — Porto, Portugal
• Dedinje Cardiovascular Institute — Belgrade, Serbia
• National University of Singapore — Singapore, Singapore
• Severance Cardiovascular Hospital, Yonsei University College of Medicine — Sinchŏn-dong, South Korea
• Hospital Univeritario Del Vinalopo — Alicante, Spain
• Hospital Clinic de Barcelona (ICCV) — Barcelona, Spain