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

Mario Gaudino; Massimo Lemma; Sigrid Sandner; Andreas Boening; Lamia Harik; Marc Albert; Jose Albors Martin; Jorge Alcocer; John H. Alexander; Deepak L. Bhatt; Nikolaos Bonaros; Michael Borger; Bernhard C. Danner; Piroze Davierwala; Marek A. Deja; Ruggero De Paulis; Marcus Andre Deutsch; Marcus Flather; Pieter Kappetein; Paul Kurlansky; Andre Lamy; Roberto Lorusso; Gopi Chand Mannam; Mohamed Marzouk; Ruth Masterson Creber; Milan Milojevic; Giuseppe Nasso; Nirav Patel; Ivana Petrovic; Eduard Quintana; Lokeswara Rao Sajja; Mauro Rinaldi; Lisa Rong; Igor Rudez; Marc Ruel; Elfriede Ruttmann-Ulmer; Pierre Voisine; Qiang Zhao; Zhe Zheng; Stephen E. Fremes

doi:10.1093/ejcts/ezae188

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

Mario Gaudino^*, Massimo Lemma, Sigrid Sandner, Andreas Boening, Lamia Harik, Marc Albert, Jose Albors Martin, Jorge Alcocer, John H. Alexander, Deepak L. Bhatt, Nikolaos Bonaros, Michael Borger, Bernhard C. Danner, Piroze Davierwala, Marek A. Deja, Ruggero De Paulis, Marcus Andre Deutsch, Marcus Flather, Pieter Kappetein, Paul KurlanskyAndre Lamy, Roberto Lorusso, Gopi Chand Mannam, Mohamed Marzouk, Ruth Masterson Creber, Milan Milojevic, Giuseppe Nasso, Nirav Patel, Ivana Petrovic, Eduard Quintana, Lokeswara Rao Sajja, Mauro Rinaldi, Lisa Rong, Igor Rudez, Marc Ruel, Elfriede Ruttmann-Ulmer, Pierre Voisine, Qiang Zhao, Zhe Zheng, Stephen E. Fremes

^*Corresponding author for this work

Cardiothoracic Surgery

Research output: Contribution to journal › Editorial › Academic › peer-review

Abstract

INTRODUCTION
The Randomized Comparison of the Clinical Outcomes of Single versus Multiple Arterial Grafts (ROMA) trial (NCT03217006) [1] is the largest randomized trial testing the hypothesis that multiple arterial grafting (MAG) provides superior clinical outcomes compared to single arterial grafting (SAG) in patients undergoing coronary artery bypass surgery (CABG).

Trial activities started in January 2017, the first patient was enrolled in January 2018, and the last one (# 4375) was enrolled on 14 April 2023.

Here, we summarize the first 7 years of ROMA activities, with particular focus on those aspects that may potentially be relevant for trialists interested in designing or implementing other large cardiac surgery trials. As the trial is ongoing and the primary analysis has not been performed yet, no outcomes or individual patient data are provided.

Original language	English
Article number	ezae188
Journal	European Journal of Cardio-thoracic Surgery
Volume	65
Issue number	5
DOIs	https://doi.org/10.1093/ejcts/ezae188
Publication status	Published - 1 May 2024

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Gaudino, M., Lemma, M., Sandner, S., Boening, A., Harik, L., Albert, M., Martin, J. A., Alcocer, J., Alexander, J. H., Bhatt, D. L., Bonaros, N., Borger, M., Danner, B. C., Davierwala, P., Deja, M. A., De Paulis, R., Deutsch, M. A., Flather, M., Kappetein, P., ... Fremes, S. E. (2024). The ROMA trial: 7 years of trial activities and the development of the ROMA trial network. European Journal of Cardio-thoracic Surgery, 65(5), Article ezae188. https://doi.org/10.1093/ejcts/ezae188

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title = "The ROMA trial: 7 years of trial activities and the development of the ROMA trial network",

abstract = "INTRODUCTIONThe Randomized Comparison of the Clinical Outcomes of Single versus Multiple Arterial Grafts (ROMA) trial (NCT03217006) [1] is the largest randomized trial testing the hypothesis that multiple arterial grafting (MAG) provides superior clinical outcomes compared to single arterial grafting (SAG) in patients undergoing coronary artery bypass surgery (CABG).Trial activities started in January 2017, the first patient was enrolled in January 2018, and the last one (# 4375) was enrolled on 14 April 2023.Here, we summarize the first 7 years of ROMA activities, with particular focus on those aspects that may potentially be relevant for trialists interested in designing or implementing other large cardiac surgery trials. As the trial is ongoing and the primary analysis has not been performed yet, no outcomes or individual patient data are provided.",

author = "Mario Gaudino and Massimo Lemma and Sigrid Sandner and Andreas Boening and Lamia Harik and Marc Albert and Martin, {Jose Albors} and Jorge Alcocer and Alexander, {John H.} and Bhatt, {Deepak L.} and Nikolaos Bonaros and Michael Borger and Danner, {Bernhard C.} and Piroze Davierwala and Deja, {Marek A.} and {De Paulis}, Ruggero and Deutsch, {Marcus Andre} and Marcus Flather and Pieter Kappetein and Paul Kurlansky and Andre Lamy and Roberto Lorusso and Mannam, {Gopi Chand} and Mohamed Marzouk and Creber, {Ruth Masterson} and Milan Milojevic and Giuseppe Nasso and Nirav Patel and Ivana Petrovic and Eduard Quintana and Sajja, {Lokeswara Rao} and Mauro Rinaldi and Lisa Rong and Igor Rudez and Marc Ruel and Elfriede Ruttmann-Ulmer and Pierre Voisine and Qiang Zhao and Zhe Zheng and Fremes, {Stephen E.}",

year = "2024",

month = may,

day = "1",

doi = "10.1093/ejcts/ezae188",

language = "English",

volume = "65",

journal = "European Journal of Cardio-thoracic Surgery",

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Gaudino, M, Lemma, M, Sandner, S, Boening, A, Harik, L, Albert, M, Martin, JA, Alcocer, J, Alexander, JH, Bhatt, DL, Bonaros, N, Borger, M, Danner, BC, Davierwala, P, Deja, MA, De Paulis, R, Deutsch, MA, Flather, M, Kappetein, P, Kurlansky, P, Lamy, A, Lorusso, R, Mannam, GC, Marzouk, M, Creber, RM, Milojevic, M, Nasso, G, Patel, N, Petrovic, I, Quintana, E, Sajja, LR, Rinaldi, M, Rong, L, Rudez, I, Ruel, M, Ruttmann-Ulmer, E, Voisine, P, Zhao, Q, Zheng, Z & Fremes, SE 2024, 'The ROMA trial: 7 years of trial activities and the development of the ROMA trial network', European Journal of Cardio-thoracic Surgery, vol. 65, no. 5, ezae188. https://doi.org/10.1093/ejcts/ezae188

TY - JOUR

T1 - The ROMA trial: 7 years of trial activities and the development of the ROMA trial network

AU - Gaudino, Mario

AU - Lemma, Massimo

AU - Sandner, Sigrid

AU - Boening, Andreas

AU - Harik, Lamia

AU - Albert, Marc

AU - Martin, Jose Albors

AU - Alcocer, Jorge

AU - Alexander, John H.

AU - Bhatt, Deepak L.

AU - Bonaros, Nikolaos

AU - Borger, Michael

AU - Danner, Bernhard C.

AU - Davierwala, Piroze

AU - Deja, Marek A.

AU - De Paulis, Ruggero

AU - Deutsch, Marcus Andre

AU - Flather, Marcus

AU - Kappetein, Pieter

AU - Kurlansky, Paul

AU - Lamy, Andre

AU - Lorusso, Roberto

AU - Mannam, Gopi Chand

AU - Marzouk, Mohamed

AU - Creber, Ruth Masterson

AU - Milojevic, Milan

AU - Nasso, Giuseppe

AU - Patel, Nirav

AU - Petrovic, Ivana

AU - Quintana, Eduard

AU - Sajja, Lokeswara Rao

AU - Rinaldi, Mauro

AU - Rong, Lisa

AU - Rudez, Igor

AU - Ruel, Marc

AU - Ruttmann-Ulmer, Elfriede

AU - Voisine, Pierre

AU - Zhao, Qiang

AU - Zheng, Zhe

AU - Fremes, Stephen E.

PY - 2024/5/1

Y1 - 2024/5/1

N2 - INTRODUCTIONThe Randomized Comparison of the Clinical Outcomes of Single versus Multiple Arterial Grafts (ROMA) trial (NCT03217006) [1] is the largest randomized trial testing the hypothesis that multiple arterial grafting (MAG) provides superior clinical outcomes compared to single arterial grafting (SAG) in patients undergoing coronary artery bypass surgery (CABG).Trial activities started in January 2017, the first patient was enrolled in January 2018, and the last one (# 4375) was enrolled on 14 April 2023.Here, we summarize the first 7 years of ROMA activities, with particular focus on those aspects that may potentially be relevant for trialists interested in designing or implementing other large cardiac surgery trials. As the trial is ongoing and the primary analysis has not been performed yet, no outcomes or individual patient data are provided.

AB - INTRODUCTIONThe Randomized Comparison of the Clinical Outcomes of Single versus Multiple Arterial Grafts (ROMA) trial (NCT03217006) [1] is the largest randomized trial testing the hypothesis that multiple arterial grafting (MAG) provides superior clinical outcomes compared to single arterial grafting (SAG) in patients undergoing coronary artery bypass surgery (CABG).Trial activities started in January 2017, the first patient was enrolled in January 2018, and the last one (# 4375) was enrolled on 14 April 2023.Here, we summarize the first 7 years of ROMA activities, with particular focus on those aspects that may potentially be relevant for trialists interested in designing or implementing other large cardiac surgery trials. As the trial is ongoing and the primary analysis has not been performed yet, no outcomes or individual patient data are provided.

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U2 - 10.1093/ejcts/ezae188

DO - 10.1093/ejcts/ezae188

M3 - Editorial

C2 - 38758192

AN - SCOPUS:85193539734

SN - 1010-7940

VL - 65

JO - European Journal of Cardio-thoracic Surgery

JF - European Journal of Cardio-thoracic Surgery

IS - 5

M1 - ezae188

ER -

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

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