Appropriateness of the modality of revascularization according to the SYNTAX 2020 in the FASTTRACK CABG study

Abstract

Abstract Objectives To compare the modality of revascularization selected by the local heart team to the one recommended by the core laboratory according to the SYNTAX score 2020 amongst patients with three-vessel disease (3VD) with or without left main disease (LMCAD), who were allocated to CABG planned and solely guided by coronary computerized tomographic angiography in the FASTTRACK CABG trial. Background Personalized long term vital prognosis plays a key role in deciding between PCI and coronary artery bypass grafting (CABG) in patients with complex coronary artery disease. Methods In an interim analysis requested by the Data Safety Monitoring Board the treatment recommendations according to the SYNTAX 2020 were prospectively assessed in 57 consecutive patients (half of the planned population in this First in Man) by a core laboratory and compared to the decision of the “on site” heart team. Results According to SS-2020, the predicted absolute risk difference (ARD) in mortality between the virtual PCI treatment population and the CABG treatment group, which can be considered a virtual surrogate for the average treatment effect, increased with the duration of follow up, from 4.8±3.5% at 5 years to 8.8±5.1% at 10 years (Table 1). The ARD of less than 0% in mortality at 5-year in favour of PCI was only documented in two patients while the 55 remaining patients had a predicted survival benefit over PCI if receiving CABG. However, based on a novel threshold of equipoise (ARD <4.5%) recently validated in a contemporary registry of 3VD and LMCAD, CABG was mandatory in 26 (45.6%) patients, whereas PCI or CABG could have been equally selected in 31 (54.4%) patients (Figure 1). Conclusions According to the SYNTAX Score 2020 there was a strict observance of the CABG treatment recommendation in the first 57 consecutive patients with 3VD or LMCAD, screened on site in the FAST TRACK CABG trial. The more lenient selection criteria derived from the contemporary regitry will have to be tested propectively. Application of artificial intelligence with expanded collection of baseline characteristics, scientific endorsement and regulatory enforcement as well as further prospective evaluation are the challenges of future decision-making scores, that should be ultimately shared with the patients. Funding Acknowledgement Type of funding sources: None.