Coronary Artery DiseaseROMANCT03217006
Randomization of Single vs Multiple Arterial Grafts
A study testing Single arterial graft and Multiple arterial grafting in people with Coronary Artery Disease and Heart Diseases, run by Weill Medical College of Cornell University at 59 sites in 17 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Artery Disease, Heart Diseases
- What is being tested?
- Single arterial graft and Multiple arterial grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,300 participants
- Where
- 59 sitesin 17 countries
- Study dates
- 7 Jan 2018to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
59 sites in 17 countries. Contact the study team or a site near you to ask about taking part.
59 sites in 17 countries
United States11 sites, 11 recruiting
- Recruiting
University of Colorado
Boulder, Colorado, 80309
Jessica Rove
Jessica Rove
- Recruiting
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Sandhya Balaram, MD
Sandhya Balaram, MD
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44106
Faisal Bakaeen, bakaeef@ccf.org
Faisal Bakaeen
- Recruiting
Nebraska Heart Hospital
Lincoln, Nebraska, 68526
Thomas Kleisli
Thomas Kleisli
- Recruiting
Icahn School of Medicine, Mount Sinai
New York, New York, 10029
John Puskas, John.Puskas@mountsinai.org
John Puskas
- Recruiting
Weil Cornell Medical College Department of Cardiothoracic Surgery
New York, New York, 10065
Mario FL Gaudino, MD, 212-746-1815, mfg9004@med.cornell.edu
Nathan T Palaparthi, MS, 212-746-5194, ntp2001@med.cornell.edu
- Recruiting
Lenox Hill Hospital (Northwell)
New York, New York, 10075
Nirav Patel, nipatel@northwell.edu
Nirav Patel
- Recruiting
NewYork-Presbyterian Queens
New York, New York, 11355
Charles Mack, MD
Charles Mack, MD
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Aleem Siddique
Aleem Siddique
- Recruiting
Allegheny General Hospital (Cardiovascular Institute)
Pittsburgh, Pennsylvania, 15232
Scott Halbreiner, Scott.halbreiner@ahn.org
Scott Halbreiner
- Recruiting
Baystate Health
Springfield, Massachusetts, 01109
Daniel Engelman, Daniel.Engelman@baystatehealth.org
Daniel Engelman
Germany11 sites, 11 recruiting
- Recruiting
Duisburg Heart Center
Duisburg
Jochen Börgermann, jochen.boergermann@evkln.de
Jochen Börgermann
- Recruiting
Essen University
Duisburg
Matthias Klaus Thielmann, Matthias.Thielmann@uk-essen.de
Matthias Klaus Thielmann
- Recruiting
Düsseldorf University
Düsseldorf
Alexander Assmann
Alexander Assmann
- Recruiting
University Hospital Erlangen
Erlangen
Ehab Nooh, ehab.nooh@uk-erlangen.de
Ehab Nooh
- Recruiting
Giessen Hospital
Giessen
Andreas Boening, andreas.boening@chiru.med.uni-giessen.de
Andreas Boening
- Enrolling by invitation
University Medical Center of Goettingen
Göttingen
- Recruiting
Jena University Hospital
Jena
Torsten Doenst
Torsten Doenst
- Recruiting
Heart Center (Herzzentrum)
Leipzig
Michael Borger
Michael Borger
- Recruiting
HDZ NRW Bad
Oeynhausen
Kavous Haikim- Meibodi, khakim-meibodi@hdz-nrw.de
Kavous Haikim- Meibodi
- Recruiting
Robert-Bosch-Hospital
Stuttgart
Marc Albert, marc.albert@rbk.de
Marc Alber
- Recruiting
Krankenhaus der Barmherzigen Brüder Trier
Trier
Terrence John Donovan
Terrence John Donovan
Canada9 sites, 9 recruiting
- Recruiting
Hamilton General Hospital
Hamilton
Andre Lamy, lamya@mcmaster.ca
Andre Lamy
- Recruiting
London Health Sciences Ontario Canada
London
Michael Chu, Michael.chu@lhsc.on.ca
Michael Chu
- Recruiting
University Hospital of Montreal (CHUM)
Montreal
Nicolas Noiseux
Nicolas Noiseux
- Recruiting
University of Ottawa Heart Institute Canada
Ottawa
Marc Ruel, mruel@ottawaheart.ca
Marc Ruel
- Recruiting
Royal Victoria Hospital (McGill)
Québec
Kevin Lachapelle,
Kevin Lachapelle
- Recruiting
Universite Laval Quebec (CRIUCPQ) Canada
Québec
Pierre Voisine, pierre.voisine@chg.ulaval.ca
Pierre Voisine
- Recruiting
Sunnybrook Health Sciences Centre
Toronto
Stephen Fremes, Stephen.Fremes@sunnybrook.ca
Stephen Fremes
- Recruiting
Toronto General Hospital
Toronto
Vivek Rao
Vivek Rao
- Recruiting
St. Boniface General Hospital / WHRA
Winnipeg
Rakesh Arora
Rakesh Arora
Italy6 sites, 6 recruiting
- Recruiting
Anthea Hospital
Bari
Giuseppe Speziale, gspeziale@gvmnet.it
Giuseppe Speziale
- Recruiting
Fondazione Poliambulanza
Brescia
Gianni Troise, giovanni.troise@poliambulanza.it
Gianni Troise
- Recruiting
Maria Cecilia Hospital GVM
Cotignola
Alberto Albertini
Alberto Albertini
- Recruiting
Universita' Cattolica del Sacro Cuore
Roma
Massimo Massetti, massimo.massetti@unicatt.it
Massimo Massetti
- Recruiting
European Hospital
Rome
Ruggero De Paulis, depauli@tin.it
Ruggero De Paulis
- Recruiting
Ospedale Le Molinette
Torino
Mauro Rinaldi, mauro.rinaldi@unito.it
Mauro Rinaldi
China5 sites, 5 recruiting
- Recruiting
Fuwai Hospital
Beijing
Zhe Zheng, zhengzhe@fuwai.com
Zhe Zheng
- Recruiting
Jilin Heart Hospital
Changchun
Massimo Lemma, dr.lemma@jlheart.org
Massimo Lemma
- Recruiting
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai
Qiang Zhao, zq11607@rjh.com.cn
Qiang Zhao
- Recruiting
National Taiwan University Hospital
Taiwan
Yih-Sharng Chen, yschen1234@gmail.com
Yih-Sharng Chen
- Recruiting
Teda Hospital (TICH)
Tianjin
Guo-Wei He, gwhezj@163.com
Guo-Wei He
Austria3 sites, 3 recruiting
- Recruiting
Innsbruck (Medical University) Austria
Innsbruck
Elfriede Ruttmann-Ulmer, Elfriede.Ruttmann@i-med.ac.at
Elfriede Ruttmann-Ulmer
- Recruiting
Krankenhaus Nord Vienna North Hospital
Vienna
Berhard Winkler, bernhard.winkler@wienkav.at
Berhard Winkler
- Recruiting
MU Vienna Austria
Vienna
Sigrid Sandner, sigrid.sandner@meduniwien.ac.at
Sigrid Sandner
Portugal3 sites, 3 recruiting
- Recruiting
Hospitalar de Lisboa Central
Capuchos
Miguel Sousa Uva
Miguel Sousa Uva
- Recruiting
University Hospital (Praceta Mota Pinto)
Coimbra
Manuel Antunes, Mjantunes48@sapo.pt
Manuel Antunes
- Recruiting
Centro Hospitalar e Universitário São João
Porto
Adelino Leite-Moreira
Adelino Leite-Moreira
Spain2 sites, 2 recruiting
- Recruiting
Hospital Univeritario Del Vinalopo
Alicante
Jose Albors Martin
Jose Albors Martin
- Recruiting
Hospital Clinic de Barcelona (ICCV)
Barcelona
Jorge Alcocer
Jorge Alcocer
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Sao Paulo
São Paulo
Fabio Biscegli Jatene
Fabio Biscegli Jatene
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Dubrava
Zagreb
Igor Rudez, rudi@kbd.hr
Igor Rudez
Czechia1 site, 1 recruiting
- Recruiting
General University Hospital, Prague
Prague
Tomas Prskavec
Tomas Prskavec
Japan1 site, 1 recruiting
- Recruiting
Saitama Medical University
Saitama
Hiroyuki Nakajima, nakajim@saitama-med.ac.jp
Hiroyuki Nakajima
Netherlands1 site, 1 recruiting
- Recruiting
MUMC Maastricht (University Medical Centre)
Maastricht
Roberto Lorusso, Roberto.lorussobs@gmail.com;
Roberto Lorusso
Poland1 site, 1 recruiting
- Recruiting
Medical University of Silesia (Katowice)
Katowice
Mark Deja
Mark Deja
Serbia1 site, 1 recruiting
- Recruiting
Dedinje Cardiovascular Institute
Belgrade
Milan Milojevic, m.milojevic@erasmusmc.nl
Milan Milojevic
Singapore1 site, 1 recruiting
- Recruiting
National University of Singapore
Singapore
Theodoros Kofidis, kofidis_theodoros@nuhs.edu.sg
Theodoros Kofidis
South Korea1 site, 1 recruiting
- Recruiting
Severance Cardiovascular Hospital, Yonsei University College of Medicine
Sinchŏn-dong
Kyung-Jong Yoo, YSGS@yuhs.ac
Kyung-Jong Yoo
About this study
Official title: Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts: the ROMA Trial
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Heart Diseases
- Being tested
- Single arterial graft, Multiple arterial grafting
- Keywords
- coronary artery bypass surgery, multiple arterial graft, radial artery graft
- Medical subject headings
- Coronary Artery Disease, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single arterial graftProcedure or surgery
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 graftingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arterial Group | Experimental | 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. Receives: Procedure: Single arterial graft |
| Multiple Arterial Group | Experimental | 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. Receives: Procedure: Multiple arterial grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Outcome
A composite of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization.
Measured: > 72 hours after surgery and/or repeat revascularization
Secondary outcomes (7)
30-day mortality
Death from any cause at 30-days
Measured: 30 days post-operatively
Major postoperative complications
Revision for bleeding, perioperative myocardial infarction, any stroke, need for dialysis, need for tracheostomy, and surgical site infection.
Measured: In-hospital stay, up to 30 days post-operatively
Sternal wound complication
Wound drainage, skin separation, unstable sternum, and sternal dehiscence, infection
Measured: 6 months post-operatively
Composite Outcome of Death from any cause
A composite of death from any cause, post discharge myocardial infarction,stroke, and/or repeat revascularization
Measured: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years.
Stroke
Post discharge myocardial infarction and repeat revascularization considered as individual events
Measured: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years.
Cause-specific death (cardiac vs non-cardiac)
Death as either cardiac or non-cardiac in etiology
Measured: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years
Hospital readmissions
Hospital readmissions with specific causes
Measured: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start7 Jan 2018
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Mario Gaudino, MD, Principal investigator, Weill Medical College of Cornell UniversityStephen Fremes, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217006
- Sponsor's protocol ID
- 1703018094
- Other IDs
- 1R01HL152021-01
- Acronym
- ROMA
- Status last verified
- Aug 2026
- First submitted
- 6 Jul 2017
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 3484393Tatoulis 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.
PubMed 14726042Lytle 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.
PubMed 10220677Taggart 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.
PubMed 11567701Yi 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.
PubMed 24916209Hillis 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. 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. Circulation. 2011 Dec 6;124(23):e652-735. doi: 10.1161/CIR.0b013e31823c074e. Epub 2011 Nov 7. No abstract available.
PubMed 22064599Authors/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.
PubMed 25173339Aldea 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.
PubMed 26680310Benedetto 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.
PubMed 24686003Nasso G, Coppola R, Bonifazi R, Piancone F, Bozzetti G, Speziale G. Arterial revascularization in primary coronary artery bypass grafting: Direct comparison of 4 strategies--results of the Stand-in-Y Mammary Study. J Thorac Cardiovasc Surg. 2009 May;137(5):1093-100. doi: 10.1016/j.jtcvs.2008.10.029. Epub 2009 Feb 7.
PubMed 19379973Taggart DP, Altman DG, Gray AM, Lees B, Gerry S, Benedetto U, Flather M; ART Investigators. Randomized Trial of Bilateral versus Single Internal-Thoracic-Artery Grafts. N Engl J Med. 2016 Dec 29;375(26):2540-9. doi: 10.1056/NEJMoa1610021. Epub 2016 Nov 14.
PubMed 27959712Zhang H, Wang ZW, Wu HB, Hu XP, Zhou Z, Xu P. Radial artery graft vs. saphenous vein graft for coronary artery bypass surgery : which conduit offers better efficacy? Herz. 2014 Jun;39(4):458-65. doi: 10.1007/s00059-013-3848-5. Epub 2013 Jun 21.
PubMed 23784362Harskamp RE, Alexander JH, Ferguson TB Jr, Hager R, Mack MJ, Englum B, Wojdyla D, Schulte PJ, Kouchoukos NT, de Winter RJ, Gibson CM, Peterson ED, Harrington RA, Smith PK, Lopes RD. Frequency and Predictors of Internal Mammary Artery Graft Failure and Subsequent Clinical Outcomes: Insights From the Project of Ex-vivo Vein Graft Engineering via Transfection (PREVENT) IV Trial. Circulation. 2016 Jan 12;133(2):131-8. doi: 10.1161/CIRCULATIONAHA.115.015549. Epub 2015 Dec 8.
PubMed 26647082Lopes RD, Mehta RH, Hafley GE, Williams JB, Mack MJ, Peterson ED, Allen KB, Harrington RA, Gibson CM, Califf RM, Kouchoukos NT, Ferguson TB Jr, Alexander JH; Project of Ex Vivo Vein Graft Engineering via Transfection IV (PREVENT IV) Investigators. Relationship between vein graft failure and subsequent clinical outcomes after coronary artery bypass surgery. Circulation. 2012 Feb 14;125(6):749-56. doi: 10.1161/CIRCULATIONAHA.111.040311. Epub 2012 Jan 11.
PubMed 22238227Shavadia J, Norris CM, Graham MM, Verma S, Ali I, Bainey KR. Symptomatic graft failure and impact on clinical outcome after coronary artery bypass grafting surgery: Results from the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease registry. Am Heart J. 2015 Jun;169(6):833-40. doi: 10.1016/j.ahj.2015.02.022. Epub 2015 Mar 13.
PubMed 26027621
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts: the ROMA Trial
- ClinicalTrials.gov ID
- NCT03217006
- Acronym / sponsor ID
- ROMA / 1703018094
- Conditions
- Coronary Artery Disease, Heart Diseases
- Keywords
- coronary artery bypass surgery, multiple arterial graft, radial artery graft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,300 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Canadian Institutes of Health Research (CIHR)
- Study start
- 7 Jan 2018 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single Arterial Group | Experimental | Procedure: Single arterial graftPatients 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 Group | Experimental | Procedure: Multiple arterial graftingPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- Age > 70 years
- Single graft
- Emergency operation
- Evolving myocardial infarction within 48 hours of surgery
- Left ventricular ejection fraction of < 35%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single arterial graftThis 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. | Procedure or surgery | Single Arterial Group |
| Multiple arterial graftingThis 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. | Procedure or surgery | Multiple Arterial Group |
Primary outcome
Composite Outcome
Time frame: > 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.
7 secondary outcomes
30-day mortality
Time frame: 30 days post-operatively
Major postoperative complications
Time frame: In-hospital stay, up to 30 days post-operatively
Sternal wound complication
Time frame: 6 months post-operatively
Composite Outcome of Death from any cause
Time frame: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years.
Stroke
Time frame: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years.
Cause-specific death (cardiac vs non-cardiac)
Time frame: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years
Hospital readmissions
Time frame: Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 3484393Loop 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.
- Background: PubMed 14726042Tatoulis 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.
- Background: PubMed 10220677Lytle 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.
- Background: PubMed 11567701Taggart 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.
- Background: PubMed 24916209Yi 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.
- Background: PubMed 22064599Hillis 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. 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. Circulation. 2011 Dec 6;124(23):e652-735. doi: 10.1161/CIR.0b013e31823c074e. Epub 2011 Nov 7. No abstract available.
- Background: PubMed 25173339Authors/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.
- Background: PubMed 26680310Aldea 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.
- Background: PubMed 24686003Benedetto 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.
- Background: PubMed 19379973Nasso G, Coppola R, Bonifazi R, Piancone F, Bozzetti G, Speziale G. Arterial revascularization in primary coronary artery bypass grafting: Direct comparison of 4 strategies--results of the Stand-in-Y Mammary Study. J Thorac Cardiovasc Surg. 2009 May;137(5):1093-100. doi: 10.1016/j.jtcvs.2008.10.029. Epub 2009 Feb 7.
- Background: PubMed 27959712Taggart DP, Altman DG, Gray AM, Lees B, Gerry S, Benedetto U, Flather M; ART Investigators. Randomized Trial of Bilateral versus Single Internal-Thoracic-Artery Grafts. N Engl J Med. 2016 Dec 29;375(26):2540-9. doi: 10.1056/NEJMoa1610021. Epub 2016 Nov 14.
- Background: PubMed 23784362Zhang H, Wang ZW, Wu HB, Hu XP, Zhou Z, Xu P. Radial artery graft vs. saphenous vein graft for coronary artery bypass surgery : which conduit offers better efficacy? Herz. 2014 Jun;39(4):458-65. doi: 10.1007/s00059-013-3848-5. Epub 2013 Jun 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mario Gaudino, MD principal investigator
Weill Medical College of Cornell University
Stephen Fremes, MD principal investigator
Sunnybrook Health Sciences Centre
59 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single arterial graft and Multiple arterial grafting in people with Coronary Artery Disease and Heart Diseases, run by Weill Medical College of Cornell University at 59 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, Germany, Canada, Italy, China and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario Gaudino, MD (212.746.1812, mfg9004@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Outcome (time frame: > 72 hours after surgery and/or repeat revascularization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03217006, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.