Appropriateness of the modality of revascularization according to the SYNTAX Score II 2020 in the FASTTRACK CABG study: An interim report on patient selection

Kai Ninomiya; Patrick W Serruys; Scot Garg; Shinichiro Masuda; Shigetaka Kageyama; Nozomi Kotoku; Marie Angele Morel; Charles Taylor; John D Puskas; Jagat Narula; Ulrich Schneider; Torsten Doenst; Kaoru Tanaka; Johan De Mey; Mark La Meir; Saima Mushtaq; Antonio L Bartorelli; Giulio Pompilio; Daniele Andreini; Yoshinobu Onuma

doi:10.1016/j.carrev.2023.01.001

Appropriateness of the modality of revascularization according to the SYNTAX Score II 2020 in the FASTTRACK CABG study: An interim report on patient selection

Kai Ninomiya, Patrick W Serruys, Scot Garg, Shinichiro Masuda, Shigetaka Kageyama, Nozomi Kotoku, Marie Angele Morel, Charles Taylor, John D Puskas, Jagat Narula, Ulrich Schneider, Torsten Doenst, Kaoru Tanaka, Johan De Mey, Mark La Meir, Saima Mushtaq, Antonio L Bartorelli, Giulio Pompilio, Daniele Andreini, Yoshinobu Onuma

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Abstract

BACKGROUND: Personalized long term vital prognosis plays a key role in deciding between percutaneous coronary intervention (PCI) and CABG in patients with complex coronary artery disease. The FASTTRACK CABG trial enrolls patients with the sole guidance of coronary computed tomographic angiography (CCTA) and fractional flow reserve CCTA (FFRCT). The feasibility/non-feasibility of this approach is determined by the surgeon request to have access to the invasive coronary angiography.

METHODS: This interim analysis, which was requested by the Data and Safety Monitoring Board (DSMB), compared the treatment decision of the "on site" Heart team to the recommended treatment as per the SYNTAX Score II 2020 (SS-2020), which was prospectively assessed by the central core laboratory in the first 57 consecutive patients (half of the planned population) enrolled in this First in Man study.

RESULTS: The average anatomical SYTAX Score is 35.6 ± 11.5. The SS-2020 predicted 5-year MACE and 10-year all-cause mortality are 14.7 % and 21.6 % following CABG, and 23.0 % and 30.4 % following PCI. Among the enrolled patients the SS-2020 predicts long-term PCI outcomes similar to CABG (absolute risk difference ≤0 % in favor of PCI) in only two patients whilst the remaining 55 patients had a predicted survival benefit with CABG.

CONCLUSIONS: According to the SS-2020, the first 57 patients recruited into the FASTTRACK CABG trial received the appropriate modality of revascularization and the DSMB allowed the investigators to complete the study.

Original language	English
Pages (from-to)	34-40
Number of pages	7
Journal	Cardiovascular Revascularization Medicine
Volume	50
Early online date	9 Jan 2023
DOIs	https://doi.org/10.1016/j.carrev.2023.01.001
Publication status	Published - May 2023

Bibliographical note

Funding Information:
The FASTTRACK CABG trial is an investigator-driven study sponsored by the National University of Ireland, Galway (NUIG). For this study, the NUIG received research grants from GE Healthcare and HeartFlow .

Funding Information:
None. The FASTTRACK CABG trial is an investigator-driven study sponsored by the National University of Ireland, Galway (NUIG). For this study, the NUIG received research grants from GE Healthcare and HeartFlow.

Publisher Copyright:
© 2023 The Authors

Copyright:
Copyright 2023 Elsevier B.V., All rights reserved.

Keywords

Coronary artery bypass grafts (CABG)
Percutaneous coronary intervention (PCI)
Risk stratification
SYNTAX Score

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Ninomiya, K., Serruys, P. W., Garg, S., Masuda, S., Kageyama, S., Kotoku, N., Morel, M. A., Taylor, C., Puskas, J. D., Narula, J., Schneider, U., Doenst, T., Tanaka, K., De Mey, J., La Meir, M., Mushtaq, S., Bartorelli, A. L., Pompilio, G., Andreini, D., & Onuma, Y. (2023). Appropriateness of the modality of revascularization according to the SYNTAX Score II 2020 in the FASTTRACK CABG study: An interim report on patient selection. Cardiovascular Revascularization Medicine, 50, 34-40. https://doi.org/10.1016/j.carrev.2023.01.001

Ninomiya, Kai ; Serruys, Patrick W ; Garg, Scot ; Masuda, Shinichiro ; Kageyama, Shigetaka ; Kotoku, Nozomi ; Morel, Marie Angele ; Taylor, Charles ; Puskas, John D ; Narula, Jagat ; Schneider, Ulrich ; Doenst, Torsten ; Tanaka, Kaoru ; De Mey, Johan ; La Meir, Mark ; Mushtaq, Saima ; Bartorelli, Antonio L ; Pompilio, Giulio ; Andreini, Daniele ; Onuma, Yoshinobu. / Appropriateness of the modality of revascularization according to the SYNTAX Score II 2020 in the FASTTRACK CABG study : An interim report on patient selection. In: Cardiovascular Revascularization Medicine. 2023 ; Vol. 50. pp. 34-40.

@article{61429711f36a480c828463441a1ed093,

title = "Appropriateness of the modality of revascularization according to the SYNTAX Score II 2020 in the FASTTRACK CABG study: An interim report on patient selection",

abstract = "BACKGROUND: Personalized long term vital prognosis plays a key role in deciding between percutaneous coronary intervention (PCI) and CABG in patients with complex coronary artery disease. The FASTTRACK CABG trial enrolls patients with the sole guidance of coronary computed tomographic angiography (CCTA) and fractional flow reserve CCTA (FFRCT). The feasibility/non-feasibility of this approach is determined by the surgeon request to have access to the invasive coronary angiography.METHODS: This interim analysis, which was requested by the Data and Safety Monitoring Board (DSMB), compared the treatment decision of the {"}on site{"} Heart team to the recommended treatment as per the SYNTAX Score II 2020 (SS-2020), which was prospectively assessed by the central core laboratory in the first 57 consecutive patients (half of the planned population) enrolled in this First in Man study.RESULTS: The average anatomical SYTAX Score is 35.6 ± 11.5. The SS-2020 predicted 5-year MACE and 10-year all-cause mortality are 14.7 % and 21.6 % following CABG, and 23.0 % and 30.4 % following PCI. Among the enrolled patients the SS-2020 predicts long-term PCI outcomes similar to CABG (absolute risk difference ≤0 % in favor of PCI) in only two patients whilst the remaining 55 patients had a predicted survival benefit with CABG.CONCLUSIONS: According to the SS-2020, the first 57 patients recruited into the FASTTRACK CABG trial received the appropriate modality of revascularization and the DSMB allowed the investigators to complete the study.",

keywords = "Coronary artery bypass grafts (CABG), Percutaneous coronary intervention (PCI), Risk stratification, SYNTAX Score",

author = "Kai Ninomiya and Serruys, {Patrick W} and Scot Garg and Shinichiro Masuda and Shigetaka Kageyama and Nozomi Kotoku and Morel, {Marie Angele} and Charles Taylor and Puskas, {John D} and Jagat Narula and Ulrich Schneider and Torsten Doenst and Kaoru Tanaka and {De Mey}, Johan and {La Meir}, Mark and Saima Mushtaq and Bartorelli, {Antonio L} and Giulio Pompilio and Daniele Andreini and Yoshinobu Onuma",

note = "Funding Information: The FASTTRACK CABG trial is an investigator-driven study sponsored by the National University of Ireland, Galway (NUIG). For this study, the NUIG received research grants from GE Healthcare and HeartFlow . Funding Information: None. The FASTTRACK CABG trial is an investigator-driven study sponsored by the National University of Ireland, Galway (NUIG). For this study, the NUIG received research grants from GE Healthcare and HeartFlow. Publisher Copyright: {\textcopyright} 2023 The Authors Copyright: Copyright 2023 Elsevier B.V., All rights reserved.",

year = "2023",

month = may,

doi = "10.1016/j.carrev.2023.01.001",

language = "English",

volume = "50",

pages = "34--40",

journal = "Cardiovascular Revascularization Medicine",

issn = "1553-8389",

publisher = "Elsevier Inc.",

}

Ninomiya, K, Serruys, PW, Garg, S, Masuda, S, Kageyama, S, Kotoku, N, Morel, MA, Taylor, C, Puskas, JD, Narula, J, Schneider, U, Doenst, T, Tanaka, K , De Mey, J , La Meir, M, Mushtaq, S, Bartorelli, AL, Pompilio, G, Andreini, D & Onuma, Y 2023, 'Appropriateness of the modality of revascularization according to the SYNTAX Score II 2020 in the FASTTRACK CABG study: An interim report on patient selection', Cardiovascular Revascularization Medicine, vol. 50, pp. 34-40. https://doi.org/10.1016/j.carrev.2023.01.001

Appropriateness of the modality of revascularization according to the SYNTAX Score II 2020 in the FASTTRACK CABG study : An interim report on patient selection. / Ninomiya, Kai; Serruys, Patrick W; Garg, Scot; Masuda, Shinichiro; Kageyama, Shigetaka; Kotoku, Nozomi; Morel, Marie Angele; Taylor, Charles; Puskas, John D; Narula, Jagat; Schneider, Ulrich; Doenst, Torsten; Tanaka, Kaoru ; De Mey, Johan ; La Meir, Mark; Mushtaq, Saima; Bartorelli, Antonio L; Pompilio, Giulio; Andreini, Daniele; Onuma, Yoshinobu.

In: Cardiovascular Revascularization Medicine, Vol. 50, 05.2023, p. 34-40.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Appropriateness of the modality of revascularization according to the SYNTAX Score II 2020 in the FASTTRACK CABG study

T2 - An interim report on patient selection

AU - Ninomiya, Kai

AU - Serruys, Patrick W

AU - Garg, Scot

AU - Masuda, Shinichiro

AU - Kageyama, Shigetaka

AU - Kotoku, Nozomi

AU - Morel, Marie Angele

AU - Taylor, Charles

AU - Puskas, John D

AU - Narula, Jagat

AU - Schneider, Ulrich

AU - Doenst, Torsten

AU - Tanaka, Kaoru

AU - De Mey, Johan

AU - La Meir, Mark

AU - Mushtaq, Saima

AU - Bartorelli, Antonio L

AU - Pompilio, Giulio

AU - Andreini, Daniele

AU - Onuma, Yoshinobu

N1 - Funding Information: The FASTTRACK CABG trial is an investigator-driven study sponsored by the National University of Ireland, Galway (NUIG). For this study, the NUIG received research grants from GE Healthcare and HeartFlow . Funding Information: None. The FASTTRACK CABG trial is an investigator-driven study sponsored by the National University of Ireland, Galway (NUIG). For this study, the NUIG received research grants from GE Healthcare and HeartFlow. Publisher Copyright: © 2023 The Authors Copyright: Copyright 2023 Elsevier B.V., All rights reserved.

PY - 2023/5

Y1 - 2023/5

N2 - BACKGROUND: Personalized long term vital prognosis plays a key role in deciding between percutaneous coronary intervention (PCI) and CABG in patients with complex coronary artery disease. The FASTTRACK CABG trial enrolls patients with the sole guidance of coronary computed tomographic angiography (CCTA) and fractional flow reserve CCTA (FFRCT). The feasibility/non-feasibility of this approach is determined by the surgeon request to have access to the invasive coronary angiography.METHODS: This interim analysis, which was requested by the Data and Safety Monitoring Board (DSMB), compared the treatment decision of the "on site" Heart team to the recommended treatment as per the SYNTAX Score II 2020 (SS-2020), which was prospectively assessed by the central core laboratory in the first 57 consecutive patients (half of the planned population) enrolled in this First in Man study.RESULTS: The average anatomical SYTAX Score is 35.6 ± 11.5. The SS-2020 predicted 5-year MACE and 10-year all-cause mortality are 14.7 % and 21.6 % following CABG, and 23.0 % and 30.4 % following PCI. Among the enrolled patients the SS-2020 predicts long-term PCI outcomes similar to CABG (absolute risk difference ≤0 % in favor of PCI) in only two patients whilst the remaining 55 patients had a predicted survival benefit with CABG.CONCLUSIONS: According to the SS-2020, the first 57 patients recruited into the FASTTRACK CABG trial received the appropriate modality of revascularization and the DSMB allowed the investigators to complete the study.

AB - BACKGROUND: Personalized long term vital prognosis plays a key role in deciding between percutaneous coronary intervention (PCI) and CABG in patients with complex coronary artery disease. The FASTTRACK CABG trial enrolls patients with the sole guidance of coronary computed tomographic angiography (CCTA) and fractional flow reserve CCTA (FFRCT). The feasibility/non-feasibility of this approach is determined by the surgeon request to have access to the invasive coronary angiography.METHODS: This interim analysis, which was requested by the Data and Safety Monitoring Board (DSMB), compared the treatment decision of the "on site" Heart team to the recommended treatment as per the SYNTAX Score II 2020 (SS-2020), which was prospectively assessed by the central core laboratory in the first 57 consecutive patients (half of the planned population) enrolled in this First in Man study.RESULTS: The average anatomical SYTAX Score is 35.6 ± 11.5. The SS-2020 predicted 5-year MACE and 10-year all-cause mortality are 14.7 % and 21.6 % following CABG, and 23.0 % and 30.4 % following PCI. Among the enrolled patients the SS-2020 predicts long-term PCI outcomes similar to CABG (absolute risk difference ≤0 % in favor of PCI) in only two patients whilst the remaining 55 patients had a predicted survival benefit with CABG.CONCLUSIONS: According to the SS-2020, the first 57 patients recruited into the FASTTRACK CABG trial received the appropriate modality of revascularization and the DSMB allowed the investigators to complete the study.

KW - Coronary artery bypass grafts (CABG)

KW - Percutaneous coronary intervention (PCI)

KW - Risk stratification

KW - SYNTAX Score

UR - http://www.scopus.com/inward/record.url?scp=85146292927&partnerID=8YFLogxK

U2 - 10.1016/j.carrev.2023.01.001

DO - 10.1016/j.carrev.2023.01.001

M3 - Article

C2 - 36639338

VL - 50

SP - 34

EP - 40

JO - Cardiovascular Revascularization Medicine

JF - Cardiovascular Revascularization Medicine

SN - 1553-8389

ER -

Appropriateness of the modality of revascularization according to the SYNTAX Score II 2020 in the FASTTRACK CABG study: An interim report on patient selection

Abstract

Bibliographical note

Keywords

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