Session Name: Biomarkers: Clinical Outcomes II
Session Type: Rapid Fire Oral Abstract
Date: Tuesday, June 7, 2022
Session Time: 5:30pm-7:00pm
Presentation Time: 6:20pm-6:30pm
Location: Hynes Ballroom A
*Purpose: The purpose of this study was to validate the association of TruGraf GEP with clinical endpoints in a real-world cohort.
*Methods: This was a multicenter observational cohort analysis of the association of TruGraf GEP results with clinical endpoints and histologic findings. TruGraf was drawn at months 1, 4, 6, 9, and 12 and was surveillance biopsy-paired at months 4 and 12. TruGraf results are reported as TX (Transplant eXcellence, Negative result) or not-TX (Positive result). Patients were divided into cohorts of TX (all TruGraf results were TX), 1 Not-TX (only 1 not-TX result), and > 1 Not-TX. Endpoints of interest were graft loss or death within 12 months, IFTA grade ≥ 2 at the 12 month biopsy, de novo DSA and a composite endpoint including all of those endpoints. Dichotomous variables were analyzed with Chi Square and continuous variables were analyzed with Kruskal Wallis. Binary logistic regression was performed to identify independent associations with the composite endpoint. Finally a Kaplan-Meier analysis was performed to analyze the impact of not-TX results on graft loss, death, or lost-to-follow-up for the entire duration of follow-up.
*Results: A total of 240 subjects were enrolled in the study. Demographics and transplant characteristics are in Table 1. Both the 1 Not-TX and > 1 Not-TX cohorts showed significant differences in the proportion of subjects that developed IFTA grade ≥ 2 (Figure 1) The > 1 Not-Tx cohort developed significantly more de novo class I DSA and had a significantly higher proportion of subjects meet the composite endpoint than the TX cohort (Figure 1). The logistic regression demonstrated that for each additional Not-TX result, subjects had an 49% increased odds of meeting the composite endpoint (Table 2). Figure 2 demonstrates that subjects with all TX TruGraf results had significantly better graft survival during follow-up (p=0.002).
*Conclusions: This multicenter analysis demonstrates a strong association with TruGraf results and clinical endpoints and histologic findings. Further study of integrating TruGraf results into clinical decision-making is warranted.
To cite this abstract in AMA style:Heilman R, Park W, Mai M, Smith B, First R, Fleming J, West-Thielke P, Holman J, Stegall M. Association of Trugraf GEP with Clinical and Histological Outcomes in a Multicenter Cohort (TOGETHER Study) [abstract]. Am J Transplant. 2022; 22 (suppl 3). https://atcmeetingabstracts.com/abstract/association-of-trugraf-gep-with-clinical-and-histological-outcomes-in-a-multicenter-cohort-together-study/. Accessed January 29, 2023.
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