Interim prediction of two-year all-cause mortality in patients with de novo multivessel coronary artery disease undergoing intended multivessel PCI

Background/Introduction coronary revascularization in patients with de novo three-vessel coronary artery disease (3VD) without Left Main disease can be performed by either PCI or CABG after objective Heart Team consensus. In the ongoing Multivessel TALENT trial (NCT04390672)1, the intended multivessel PCI is performed using DES with ultrathin struts and biodegradable polymers under the guidance of quantitative flow ratio (QFR) and intracoronary imaging with IVUS or OCT. Purpose The Logistic Clinical SYNTAX score (logSYNTAX) to predict 2-year all-cause mortality after PCI was developed in 15,883 patients treated in the GLOBAL LEADERS trial and externally validated in 10,100 patients. This study aims to predict 2-year all-cause mortality after intended multivessel PCI in the currently enrolled trial population to identify patients who should be considered high risk. Methods and results We performed an interim analysis in the first consecutive 781 patients of the ongoing Multivessel TALENT Trial aimed to enrol 1550 patients. Thirteen clinical predictors are used in the logSYNTAX score: SYNTAX I-score, presence of 3VD and/or LM disease, age, creatinine clearance in mL/min, LVEF, BMI, serum hemoglobin level(g/dL), the White Blood Cell Count (WBC, in 109 cells/L) and the presence of COPD, PVD, diabetes mellitus, current smoking and/or a history of stroke. LVEF and BMI have additional squared terms to adjust for non-linear associations with all-cause mortality. The predicted mortality was estimated using the survival function developed in the GLOBAL LEADERS trial. We considered patients high-risk if the estimated risk was above the 3rd quartile. In 563 patients, all thirteen predictors necessary for 2-year mortality prediction were available. Median 2-year all-cause mortality of 1.9% (1.09-3.82; IQR2.73). 142 patients (25%) with an increased estimated 2-year mortality risk (>3.8%) due to higher prevalence of the aforementioned predictors; higher median age [75 (9.0) vs. 67 (12.0), p <0.001], a lower median LVEF [55% (20) vs. 94% (35.5), p <0.001] and a higher median SYNTAX score [26.0 (13.5) vs. 20.0(11.0), p <0.001]. A complete overview of predictors can be found in table 1. High age, an impaired LVEF, and an increased anatomical SYNTAX-I score were the main contributors to high mortality in this study cohort (see figure 1). Conclusion(s) In 563 patients, the median predicted 2-year all-cause mortality was 1.9%. Nevertheless, a non-neglectable amount of patients were estimated to be at increased risk for all-cause 2-year mortality. Accurate prediction by knowledge of aforementioned predictors is pivotal for appropriate mortality risk prediction to segregate high-risk patients with 3VD for individual decision-making on coronary revascularization, even if surgical revascularization is no option, and guide optimal treatment with use of intravascular imaging to achieve an optimal PCI result.Table 1Figure 1