The ROMA trial: 7 years of trial activities and the development of the ROMA trial network

Mario Gaudino¹, Massimo Lemma², Sigrid Sandner³, Andreas Boening⁴, Lamia Harik¹, Marc Albert⁵, Jose Albors Martin⁶, Jorge Alcocer⁷, John H Alexander⁸, Deepak L Bhatt⁹, Nikolaos Bonaros¹⁰, Michael Borger¹¹, Bernhard C Danner¹², Piroze Davierwala¹³, Marek A Deja¹⁴, Ruggero De Paulis¹⁵, Marcus-Andre Deutsch¹⁶, Marcus Flather¹⁷, Pieter Kappetein¹⁸, Paul Kurlansky¹⁹, Andre Lamy²⁰, Roberto Lorusso²¹, Gopi Chand Mannam²², Mohamed Marzouk²³, Ruth Masterson Creber²⁴, Milan Milojevic^{25

26}, Giuseppe Nasso²⁷, Nirav Patel²⁸, Ivana Petrovic²⁹, Eduard Quintana⁷, Lokeswara Rao Sajja²², Mauro Rinaldi³⁰, Lisa Rong³¹, Igor Rudez³², Marc Ruel³³, Elfriede Ruttmann-Ulmer¹⁰, Pierre Voisine³³, Qiang Zhao³⁴, Zhe Zheng³⁵, Stephen E Fremes³⁶

Affiliations

¹ Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, NY, USA.
² Department of Cardiac Surgery, Jilin Heart Hospital, Changchun, China.
³ Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
⁴ Department of Cardiovascular Surgery, University Hospital Giessen, Giessen, Germany.
⁵ Department of Cardiovascular Surgery, Robert-Bosch Hospital, Stuttgart, Germany.
⁶ Department of Cardiac Surgery, Hospital Universitario del Vinalopo, Alicante, Spain.
⁷ Department of Cardiac Surgery, Hospital Clinic de Barcelona, Barcelona, Spain.
⁸ Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC, USA.
⁹ Department of Medicine, Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
¹⁰ Department of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.
¹¹ Department of Cardiac Surgery, Leipzig Heart Center, Leipzig, Germany.
¹² Department of Thoracic and Cardiovascular Surgery, University Hospital of Goettingen, Goettingen, Germany.
¹³ Department of Surgery, Division of Cardiac Surgery, Toronto General Hospital, Toronto, ON, Canada.
¹⁴ Department of Cardiac Surgery, Medical University of Silesia-Katowice, Katowice, Poland.
¹⁵ Department of Cardiac Surgery, European Hospital, Unicamillus University, Rome, Italy.
¹⁶ Department of Thoracic and Cardiovascular Surgery, HDZ NRW, University Hospital Ruhr-University Bochum, Bad Oeynhausen, Germany.
¹⁷ Department of Medicine, Norwich Medical School, University of East Anglia, Norwich, UK.
¹⁸ Medtronic Bakken Research Center, Maastricht, Netherlands.
¹⁹ Department of Surgery, Columbia University College of Physicians and Surgeons, New York, NY, USA.
²⁰ Department of Surgery, McMaster University, Hamilton, ON, Canada.
²¹ Department of Cardio-Thoracic Surgery, Maastricht University Medical Center and Cardiovascular Research Maastricht, Maastricht, Netherlands.
²² Department of Cardiothoracic Surgery, Star Hospitals, Hyderabad, India.
²³ Department of Cardiovascular Surgery, IUCPQ, Universite Laval, Quebec City, QC, Canada.
²⁴ Columbia University School of Nursing, New York, NY, USA.
²⁵ Department of Cardiac Surgery and Cardiovascular Research, Dedinje Cardiovascular Institute, Belgrade, Serbia.
²⁶ Department of Cardiothoracic Surgery, Erasmus MC, Rotterdam, Netherlands.
²⁷ Department of Cardiac Surgery, Anthea Hospital, Bari, Italy.
²⁸ Department of Cardiovascular and Thoracic Surgery, Northwell Health, New Hyde Park, NY, USA.
²⁹ Department of Cardiosurgery, Center of Excellence, Dedinje Cardiovascular Institute, Belgrade, Serbia.
³⁰ Department of Cardiac Surgery, University of Turin, Turin, Italy.
³¹ Department of Anesthesia, Weill Cornell Medicine, New York, NY, USA.
³² Department of Cardiac and Transplant Surgery, Dubrava University Hospital, Zagreb, Croatia.
³³ Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, ON, Canada.
³⁴ Department of Cardiac Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
³⁵ Department of Cardiac Surgery, Fuwai Hospital, Beijing, China.
³⁶ Division of Cardiac Surgery, Schulich Heart Centre, Department of Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.

PMID: 38758192
PMCID: PMC11099650
DOI: 10.1093/ejcts/ezae188

Editorial

The ROMA trial: 7 years of trial activities and the development of the ROMA trial network

Mario Gaudino et al. Eur J Cardiothorac Surg. 2024.

. 2024 May 3;65(5):ezae188.

doi: 10.1093/ejcts/ezae188.

Authors

Affiliations

¹ Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, NY, USA.
² Department of Cardiac Surgery, Jilin Heart Hospital, Changchun, China.
³ Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
⁴ Department of Cardiovascular Surgery, University Hospital Giessen, Giessen, Germany.
⁵ Department of Cardiovascular Surgery, Robert-Bosch Hospital, Stuttgart, Germany.
⁶ Department of Cardiac Surgery, Hospital Universitario del Vinalopo, Alicante, Spain.
⁷ Department of Cardiac Surgery, Hospital Clinic de Barcelona, Barcelona, Spain.
⁸ Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC, USA.
⁹ Department of Medicine, Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
¹⁰ Department of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.
¹¹ Department of Cardiac Surgery, Leipzig Heart Center, Leipzig, Germany.
¹² Department of Thoracic and Cardiovascular Surgery, University Hospital of Goettingen, Goettingen, Germany.
¹³ Department of Surgery, Division of Cardiac Surgery, Toronto General Hospital, Toronto, ON, Canada.
¹⁴ Department of Cardiac Surgery, Medical University of Silesia-Katowice, Katowice, Poland.
¹⁵ Department of Cardiac Surgery, European Hospital, Unicamillus University, Rome, Italy.
¹⁶ Department of Thoracic and Cardiovascular Surgery, HDZ NRW, University Hospital Ruhr-University Bochum, Bad Oeynhausen, Germany.
¹⁷ Department of Medicine, Norwich Medical School, University of East Anglia, Norwich, UK.
¹⁸ Medtronic Bakken Research Center, Maastricht, Netherlands.
¹⁹ Department of Surgery, Columbia University College of Physicians and Surgeons, New York, NY, USA.
²⁰ Department of Surgery, McMaster University, Hamilton, ON, Canada.
²¹ Department of Cardio-Thoracic Surgery, Maastricht University Medical Center and Cardiovascular Research Maastricht, Maastricht, Netherlands.
²² Department of Cardiothoracic Surgery, Star Hospitals, Hyderabad, India.
²³ Department of Cardiovascular Surgery, IUCPQ, Universite Laval, Quebec City, QC, Canada.
²⁴ Columbia University School of Nursing, New York, NY, USA.
²⁵ Department of Cardiac Surgery and Cardiovascular Research, Dedinje Cardiovascular Institute, Belgrade, Serbia.
²⁶ Department of Cardiothoracic Surgery, Erasmus MC, Rotterdam, Netherlands.
²⁷ Department of Cardiac Surgery, Anthea Hospital, Bari, Italy.
²⁸ Department of Cardiovascular and Thoracic Surgery, Northwell Health, New Hyde Park, NY, USA.
²⁹ Department of Cardiosurgery, Center of Excellence, Dedinje Cardiovascular Institute, Belgrade, Serbia.
³⁰ Department of Cardiac Surgery, University of Turin, Turin, Italy.
³¹ Department of Anesthesia, Weill Cornell Medicine, New York, NY, USA.
³² Department of Cardiac and Transplant Surgery, Dubrava University Hospital, Zagreb, Croatia.
³³ Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, ON, Canada.
³⁴ Department of Cardiac Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
³⁵ Department of Cardiac Surgery, Fuwai Hospital, Beijing, China.
³⁶ Division of Cardiac Surgery, Schulich Heart Centre, Department of Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.

PMID: 38758192
PMCID: PMC11099650
DOI: 10.1093/ejcts/ezae188

No abstract available

Keywords: Coronary artery bypass grafting; Multiple arterial grafting; Randomized clinical trials.

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Figures

**Figure 1:**
ROMA cumulative enrollment and the effect of the COVID-19 pandemic (panel). COVID-19: coronavirus disease 2019; ROMA: Randomized Comparison of the Clinical Outcomes of Single versus Multiple Arterial Grafts.

**Figure 2:**
Large contemporary CABG trials. ART: Arterial Revascularization Trial; CORONARY: Coronary Artery Bypass Surgery Off or On Pump Revascularization Study; EXCEL: Evaluation of XIENCE versus Coronary Artery Bypass Graft Surgery for Effectiveness of Left Main Revascularizaton trial; FREEDOM: Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease trial; NOBLE: Nordic Baltic British Left Main Revascularization trial; PREVENT IV: The PRoject of Ex vivo Vein graft ENgineering via Transfection IV trial; ROOBY: Randomized On/Off Bypass trial; ROMA: Randomized Comparison of the Clinical Outcomes of Single versus Multiple Arterial Grafts trial; SYNTAX: Synergy Between PCI with Taxus and Cardiac Surgery trial.

See this image and copyright information in PMC

References

1. Gaudino M, Alexander JH, Bakaeen FG, Ballman K, Barili F, Calafiore AM. et al. Randomized comparison of the clinical outcome of single versus multiple arterial grafts: the ROMA trial—rationale and study protocol. Eur J Cardiothorac Surg 2017;52:1031–40. - PubMed
1. Taggart DP, Altman DG, Gray AM, Lees B, Gerry S, Benedetto U. et al.; ART Investigators. Randomized trial of bilateral versus single internal-thoracic-artery grafts. N Engl J Med 2016;375:2540–9. - PubMed
1. Gaudino M, Bakaeen F, Benedetto U, Rahouma M, Di Franco A, Tam DY. et al. Use rate and outcome in bilateral internal thoracic artery grafting: insights from a systematic review and meta‐analysis. JAHA 2018;7:e009361. - PMC - PubMed
1. Benedetto 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 trials. Eur J Cardiothorac Surg 2015;47:59–65; discussion 65. - PubMed
1. Persson M, Sartipy U.. Bilateral versus single internal thoracic artery grafts. Curr Cardiol Rep 2018;20:4. - PMC - PubMed

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The ROMA trial: 7 years of trial activities and the development of the ROMA trial network

Affiliations

The ROMA trial: 7 years of trial activities and the development of the ROMA trial network

Authors

Affiliations

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources