Appropriateness of the Modality of Revascularization According to the SYNTAX Score II 2020 in the FASTTRACK CABG Study: An Interim Report on Patient Selection

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 re-serve 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 pa-tients (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.(c) 2023 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Automated summary

The feasibility of using CCTA and FFRCT as guidance in the FASTTRACK CABG trial is determined by the need for invasive coronary angiography. According to the SS-2020, the first 57 patients enrolled in the trial received the appropriate revascularization modality, and the DSMB allowed the investigators to continue the study.