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.

Appropriateness of the modality of revascularization according to the SYNTAX Score II 2020 in the FASTTRACK CABG study: An interim report on patient selection / K. Ninomiya, P.W. Serruys, S. Garg, S. Masuda, S. Kageyama, N. Kotoku, M.A. Morel, C. Taylor, J.D. Puskas, J. Narula, U. Schneider, T. Doenst, K. Tanaka, J. De Mey, M. La Meir, S. Mushtaq, A.L. Bartorelli, G. Pompilio, D. Andreini, Y. Onuma. - In: CARDIOVASCULAR REVASCULARIZATION MEDICINE. - ISSN 1553-8389. - 50:(2023 May), pp. 34-40. [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

A.L. Bartorelli;G. Pompilio;D. Andreini;
2023

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.
Coronary artery bypass grafts (CABG); Percutaneous coronary intervention (PCI); Risk stratification; SYNTAX Score;
Settore MED/23 - Chirurgia Cardiaca
mag-2023
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/958197
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