Angiographic derived physiological assessment after intervention for predicting 2-year vessel-oriented composite endpoints in Multivessel TALENT trial

Abstract

Abstract Aims The purpose of the study is to assess the treatment results in the first 200 patients in the ongoing Multivessel TALENT trial and to predict the vessel-oriented endpoint by assessing the quantitative flow ratio (QFR) post PCI in a central independent core laboratory. Methods In this prospective, randomized, 1:1 balanced, multi-centre, open-label trial, de novo multivessel coronary artery disease patients without left main disease are assigned to the sirolimus-eluting stent or everolimus-eluting stent arm. The percutaneous coronary intervention (PCI) is planned based on functional lesion evaluation by QFR provided by the Core laboratory and the PCI has to be optimized by intravascular imaging, optimal pharmacological treatment and prasugrel monotherapy. Results Mean age of the population was 66.6±14.7 years, and 78.1% of them were male. This population consists of 17.4% unstable angina and of 31.8% diabetic patients. Anatomical SYNTAX score was 18.8±9.1. Total 458 lesions were treated from September 2020 to December 2021. Left anterior descending artery accounts for 40.3%, bifurcation lesion was present in 40.8%, total occlusion in 4.2%. The average stent diameter and total stent length were 3.0±0.4mm and 38.7±22.4mm, respectively. Intravascular imaging was used in 92.8% of treated vessels (intravascular ultrasound 56.5%, optical coherent tomography 36.3%). Pre-PCI QFR was analysable in 435 vessels (0.59±0.21), and 5.5% of them were treated even though the pre-PCI QFR values were more than 0.8. Post-PCI QFR has been so far analysed in 303 vessels (0.93±0.11) and 79.5% of them achieved a post-PCI QFR equal or superior to 0.91. Based on the previous study [1], Two-year vessel-oriented composite endpoint (VOCE) was estimated to become 5.4% in the present study population (3.7% in the patient group that achieved post PCI QFR equal or superior to 0.91, while 12% in the patients who could not reach the threshold), which was almost equal to what is expected in the power calculation. Conclusions In the Multivessel TALENT trial, the large majority of the vessels treated (94.5%) complied with the hemodynamic criteria of recommended PCI as provided by the QFRs of the Core laboratory. Favourable post-PCI QFR (≥0.91) obtained in 80% of the patients let expected a favourable VOCE outcome of 5.4%. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): The National University of Ireland Galway