Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women
ROMA:Women
Randomized Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (ROMA:Women) Trial
1 other identifier
interventional
2,300
24 countries
140
Brief Summary
The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grafting (SAG). The specific aims of ROMA:Women are: Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grafting (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,300 women randomized 1:1 to MAG or SAG. Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time. Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events. Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups. Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated. Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG. Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG. Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
140 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2019
CompletedFirst Posted
Study publicly available on registry
October 11, 2019
CompletedStudy Start
First participant enrolled
April 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2030
April 1, 2026
March 1, 2026
6.9 years
October 10, 2019
March 31, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Primary outcome for aim 1: Death from any cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.
The primary outcome for aim 1 will be a composite of the first occurrence of death from any cause, any stroke, non-procedural myocardial infarction (\>48 hours after surgery), repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.
Postoperatively, minimum 2.5 year follow-up
Primary outcome for aim 2: Disease-specific quality of life
Assessed using the Seattle Angina Questionnaire (SAQ), a validated 19-item questionnaire that measures five domains related to coronary disease: angina frequency, physical limitations, quality of life, angina stability, and treatment satisfaction. Scores range from 0 to 100 with higher scores indicating fewer symptoms and better health status. The minimum clinically important difference on the SAQ is 5 points. The primary endpoint for aim 2 is the absolute change in the Seattle Angina Questionnaire (SAQ) at 12 months compared to baseline.
Postoperatively, minimum 2.5 year follow-up
Secondary Outcomes (11)
Death from any cause, any stroke, non-procedural myocardial infarction, and repeat revascularization.
Postoperatively, minimum 2.5 year follow-up
Death from cardiac cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.
Postoperatively, minimum 2.5 year follow-up
Death from any cause
Postoperatively, minimum 2.5 year follow-up
Stroke
Postoperatively, minimum 2.5 year follow-up
Non-procedural myocardial infarction
> 48 hours postoperatively, minimum 2.5 year follow-up
- +6 more secondary outcomes
Other Outcomes (1)
Other recorded outcomes (safety endpoints)
Within 30 days of surgery or during index hospitalization, whichever is longer.
Study Arms (2)
Single Arterial Graft (SAG) group
EXPERIMENTALPatients 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.
Multiple Arterial Graft (MAG) group
EXPERIMENTALPatients 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.
Interventions
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.
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
You may qualify if:
- Women patients ≥18 years old.
- Isolated coronary artery bypass grafting.
- Primary (first time) cardiac surgery procedure.
- Significant disease of the left main coronary artery or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.
You may not qualify if:
- Male gender
- Single graft
- Emergency operation
- Myocardial infarction within 72 hours of surgery
- Left ventricular ejection fraction \< 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 reduces 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cedars-Sinai Medical Centercollaborator
- Weill Medical College of Cornell Universitylead
- New York Presbyterian Hospitalcollaborator
- Sunnybrook Health Sciences Centrecollaborator
- Columbia Universitycollaborator
- Duke Universitycollaborator
Study Sites (146)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Pomona Valley Hospital Medical Center
Pomona, California, 91767, United States
University of California, San Francisco
San Francisco, California, 94118, United States
University of Colorado
Aurora, Colorado, 80045, United States
Hartford Hospital
Hartford, Connecticut, 06106, United States
Yale University Hospital
New Haven, Connecticut, 06510, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Chicago
Chicago, Illinois, 60637, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Johns Hopkins University
Baltimore, Maryland, 21218, United States
Baystate Health
Springfield, Massachusetts, 01199, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655, United States
University of Michigan
Ann Arbor, Michigan, 48104, United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Nebraska Heart Hospital
Lincoln, Nebraska, 68526, United States
Methodist Physicians Health
Omaha, Nebraska, 68118, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Englewood Health
Englewood, New Jersey, 07631, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Weill Cornell Medicine
New York, New York, 10021, United States
Columbia University Medical Center
New York, New York, 10032, United States
Lenox Hill Hospital
New York, New York, 10075, United States
New York Presbyterian Queens
Queens, New York, 11355, United States
Duke University
Durham, North Carolina, 27710, United States
East Carolina University
Greenville, North Carolina, 27858, United States
Wake Forest University
Winston-Salem, North Carolina, 27106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Genesis Healthcare System
Zanesville, Ohio, 43701, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Baylor Scott & White Research Institute
Dallas, Texas, 75204, United States
The University of Texas Medical Health Branch at Galveston
Galveston, Texas, 77550, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
UT Health San Antonio
San Antonio, Texas, 78229, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Victorian Heart Hospital
Clayton, 3168, Australia
The University of Melbourne
Melbourne, Australia
Medical University of Graz
Graz, 8010, Austria
Innsbruck Medical University
Innsbruck, 6020, Austria
Kepler University Hospital
Linz, Austria
Medical University of Vienna
Vienna, 1090, Austria
Krankenhaus Nord Vienna North Hospital
Vienna, 1210, Austria
Institute of Cardiology Porto Alegre
Porto Alegre, 9062000, Brazil
Heart Institute University of São Paulo
São Paulo, 05508, Brazil
Instituto Dante Pazzanese de Cardiologia
Vila Mariana, 04012-909, Brazil
Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
Horizon Health Network - Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Newfoundland and Labrador Health Services
St. John's, Newfoundland and Labrador, A1B 3R4, Canada
Health Sciences North
Greater Sudbury, Ontario, P3E 5J1, Canada
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
London Health Sciences
London, Ontario, N6A 5A5, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
Sunnybrook Health Sciences
Toronto, Ontario, M4N 3M5, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
University Hospital of Montreal
Montreal, Quebec, H2X 3E4, Canada
Royal Victoria Hospital
Montreal, Quebec, H4A 3J1, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Ste Foy, Quebec, G1V 4G5, Canada
Hopital Sacre-Coeur
Montreal, Canada
Fraser Clinical Trials
New Westminster, Canada
Fuwai Hospital China
Beijing, Beijing Municipality, 100037, China
Jilin Heart Hospital China
Changchun, Jilin, 130052, China
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Teda Hospital Tianjin China
Tianjin, Tianjin Municipality, 300456, China
University Hospital Dubrava
Zagreb, 10000, Croatia
University Hradec Králové
Hradec Králové, 500 03, Czechia
General University Hospital, Prague
New Town, 128 08, Czechia
Aalborg University Hospital
Aalborg, 9000, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Universitäts-Herzzentrum Bad Krozingen Freiburg
Bad Krozingen, Baden-Wurttemberg, 79189, Germany
HDZ NRW Bad Oeynhausen Germany
Bad Oeynhausen, 32545, Germany
Deutsches Herzzentrum der Charite
Berlin, Germany
Duisburg Heart Center
Duisburg, 47137, Germany
Dusseldorf University
Düsseldorf, 40225, Germany
University Hospital Erlangen
Erlangen, 91054, Germany
Essen University
Essen, 45147, Germany
Frankfurt University
Frankfurt, 60323, Germany
University Hospital of Giessen and Marburg
Giessen, 35385, Germany
University Medical Center of Göttingen
Göttingen, 37075, Germany
Heidelberg University
Heidelberg, Germany
Jena University Hospital
Jena, 07743, Germany
Heart Center Herzzentrum, Leipzig
Leipzig, 04289, Germany
TUM University Hospital German Heart Center
Munich, Germany
Robert-Bosch-Hospital Stuttgart Germany
Stuttgart, 70376, Germany
Krankenhaus der Barmherzigen Brüder Trier
Trier, 54292, Germany
G Kuppuswamy Naidu Memorial Hospital (GKNM)
Coimbatore, Tamil Nadu, 641037, India
Star Hospitals - Hyderabad, India
Hyderabad, Telangana, 500034, India
Rambam Health Care Campus
Haifa, 3109601, Israel
Anthea Hospital
Bari, 70124, Italy
Humanitas Gavazzeni of Bergamo
Bergamo, 24125, Italy
Fondazione Poliambulanza
Brescia, 25124, Italy
Maria Cecilia Hospital GVM
Cotignola, 48033, Italy
Careggi University Hospital
Florence, 50134, Italy
European Hospital
Roma, 00149, Italy
Universita' Cattolica del Sacro Cuore
Roma, 00168, Italy
Ospedale Le Molinette, Torino
Torino, 10126, Italy
Tokyo Medical and Dental University
Bunkyō-Ku, Tokyo, 113-8510, Japan
Saitama Medical University Japan
Saitama, 350-0451, Japan
Leiden University Medical Center
Leiden, South Holland, 2333, Netherlands
Erasmus Medical Center
Rotterdam, South Holland, 3015, Netherlands
Maastricht University Medical Centre
Maastricht, 6229, Netherlands
Acibadem-Sistina Hospital
Skopje, North Macedonia
Medical University Gdansk
Gdansk, 80-210, Poland
Medical University of Silesia
Katowice, 40-055, Poland
Zbigniew Religa Lower Silesian Heart Disease Centre
Zabrze, 41-800, Poland
University Hospital Coimbra
Coimbra, 3004-561, Portugal
Centro Hospitalar Lisboa Ocidental
Lisbon, 1300-598, Portugal
Centro Hospitalar e Universitário Sao Joao
Porto, 4200-072, Portugal
National Research Medical Center of the Russian Academy of Sciences - Tomsk, Russia
Tomsk, Russia
Dedinje Cardiovascular Institute
Belgrade, 11000, Serbia
National University of Singapore
Singapore, 119077, Singapore
Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 03722, South Korea
Seoul National University Hospital
Seoul, South Korea
Hospital Universitario del Vinalopo
Elche, Alicante, 03293, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Clinico de San Carlos
Madrid, Spain
NavarraBiomed
Pamplona, Spain
Sahlgrenska University Hospital
Gothenburg, Sweden
Karonlinska University Hospital
Stockholm, 171 76, Sweden
National Taiwan University Hospital
Zhongzheng, Taipei, 100229, Taiwan
Blackpool Teaching Hospitals NHS Trust
Blackpool, Lancashire, FY3 8NR, United Kingdom
Oxford University Hospitals NHS Trust
Multiple Locations, Oxford, United Kingdom
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
Royal Papworth NHS Foundation Trust
Cambridge, CB2 0A, United Kingdom
NHS Golden Jubilee
Clydebank, G81 4DY, United Kingdom
The Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA, United Kingdom
Hull University Hospitals
Hull, United Kingdom
University Hospitals of Leicester
Leicester, United Kingdom
Liverpool Heart and Chest Hospital Foundation Trust
Liverpool, L14 3PE, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH, United Kingdom
Imperial College Healthcare NHS Trust
London, W2 1NY, United Kingdom
Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
London, United Kingdom
St George's University Hospitals
London, United Kingdom
Manchester University NHS Trust
Manchester, M13 9WL, United Kingdom
South Tees Hospitals NHS Trust
Middlesbrough, TS4 3BW, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2SB, United Kingdom
Mid and South Essex NHS Foundation Trust
Westcliff-on-Sea, United Kingdom
Royal Wolverhampton NHS Trust
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (9)
Loop FD, Lytle BW, Cosgrove DM, Stewart RW, Goormastic M, Williams GW, Golding LA, Gill CC, Taylor PC, Sheldon WC, et al. Influence of the internal-mammary-artery graft on 10-year survival and other cardiac events. N Engl J Med. 1986 Jan 2;314(1):1-6. doi: 10.1056/NEJM198601023140101.
PMID: 3484393BACKGROUNDTatoulis J, Buxton BF, Fuller JA. Patencies of 2127 arterial to coronary conduits over 15 years. Ann Thorac Surg. 2004 Jan;77(1):93-101. doi: 10.1016/s0003-4975(03)01331-6.
PMID: 14726042BACKGROUNDLytle BW, Blackstone EH, Loop FD, Houghtaling PL, Arnold JH, Akhrass R, McCarthy PM, Cosgrove DM. Two internal thoracic artery grafts are better than one. J Thorac Cardiovasc Surg. 1999 May;117(5):855-72. doi: 10.1016/S0022-5223(99)70365-X.
PMID: 10220677BACKGROUNDTaggart DP, D'Amico R, Altman DG. Effect of arterial revascularisation on survival: a systematic review of studies comparing bilateral and single internal mammary arteries. Lancet. 2001 Sep 15;358(9285):870-5. doi: 10.1016/S0140-6736(01)06069-X.
PMID: 11567701BACKGROUNDYi G, Shine B, Rehman SM, Altman DG, Taggart DP. Effect of bilateral internal mammary artery grafts on long-term survival: a meta-analysis approach. Circulation. 2014 Aug 12;130(7):539-45. doi: 10.1161/CIRCULATIONAHA.113.004255. Epub 2014 Jun 10.
PMID: 24916209BACKGROUNDHillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, Cigarroa JE, Disesa VJ, Hiratzka LF, Hutter AM Jr, Jessen ME, Keeley EC, Lahey SJ, Lange RA, London MJ, Mack MJ, Patel MR, Puskas JD, Sabik JF, Selnes O, Shahian DM, Trost JC, Winniford MD; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; Society of Cardiovascular Anesthesiologists; Society of Thoracic Surgeons. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Developed in collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2011 Dec 6;58(24):e123-210. doi: 10.1016/j.jacc.2011.08.009. Epub 2011 Nov 7. No abstract available.
PMID: 22070836BACKGROUNDAuthors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.
PMID: 25173339BACKGROUNDAldea GS, Bakaeen FG, Pal J, Fremes S, Head SJ, Sabik J, Rosengart T, Kappetein AP, Thourani VH, Firestone S, Mitchell JD; Society of Thoracic Surgeons. The Society of Thoracic Surgeons Clinical Practice Guidelines on Arterial Conduits for Coronary Artery Bypass Grafting. Ann Thorac Surg. 2016 Feb;101(2):801-9. doi: 10.1016/j.athoracsur.2015.09.100. Epub 2015 Dec 8.
PMID: 26680310BACKGROUNDBenedetto U, Raja SG, Albanese A, Amrani M, Biondi-Zoccai G, Frati G. Searching for the second best graft for coronary artery bypass surgery: a network meta-analysis of randomized controlled trialsdagger. Eur J Cardiothorac Surg. 2015 Jan;47(1):59-65; discussion 65. doi: 10.1093/ejcts/ezu111. Epub 2014 Mar 30.
PMID: 24686003BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mario Gaudino, Prof/PhD/MD
Weill Medical College of Cornell University
- PRINCIPAL INVESTIGATOR
Stephen Fremes, MD
Sunnybrook Health Sciences Centre
- PRINCIPAL INVESTIGATOR
Ruth Masterson Creber, RN, PhD
Columbia University
- PRINCIPAL INVESTIGATOR
C. Noel Bairey Merz, MD
Cedars-Sinai
- PRINCIPAL INVESTIGATOR
Karla Ballman, PhD
Weill Medical College of Cornell University
- PRINCIPAL INVESTIGATOR
Sean O'Brien, PhD
Duke University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The endpoint assessors will be blinded to treatment allocation (PROBE).
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2019
First Posted
October 11, 2019
Study Start
April 17, 2023
Primary Completion (Estimated)
March 1, 2030
Study Completion (Estimated)
March 1, 2030
Last Updated
April 1, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- From publication until the third year after publication
- Access Criteria
- Research scope
Primary outcome data under request