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Novel Composite Endpoint for Assessing Outcomes in Liver Transplantation: Arterial and Biliary Complication–Free Survival
Liver Transplantation ( IF 4.7 ) Pub Date : 2021-08-17 , DOI: 10.1002/lt.26269
Eric Savier 1 , Yann De Rycke , Chetana Lim , Claire Goumard , Geraldine Rousseau , Fabiano Perdigao , Pierre Rufat , Chady Salloum , Laura Llado , Emilio Ramos , Josefina Lopez-Dominguez , Alba Cachero , Joan Fabregat , Daniel Azoulay , Olivier Scatton
Affiliation  

Transplant and patient survival are the validated endpoints to assess the success of liver transplantation (LT). This study evaluates arterial and biliary complication–free survival (ABCFS) as a new metric. ABC, considered as an event, was an arterial or biliary complication of Dindo-Clavien grade ≥III complication dated at the interventional, endoscopic, or surgical treatment required to correct it. ABCFS was defined as the time from the date of LT to the dates of first ABC, death, relisting, or last follow-up (transplant survival is time from LT to repeat LT or death). Following primary whole LT (n = 532), 106 ABCs occurred and 99 (93%) occurred during the first year after LT. An ABC occurring during the first year after LT (overall rate 19%) was an independent factor associated with transplant survival (hazard ratio [HR], 3.17; P < 0.001) and patient survival (HR, 2.7; P = 0.002) in univariate and multivariate analyses. This result was confirmed after extension of the cohort to split-liver graft, donation after circulatory death, or re-LT (n = 658). Data from 2 external cohorts of primary whole LTs (n = 249 and 229, respectively) confirmed that the first-year ABC was an independent prognostic factor for transplant survival but not for patient survival. ABCFS was correlated with transplant and patient survival (ρ = 0.85 [95% CI, 0.78-0.90] and 0.81 [95% CI, 0.71-0.88], respectively). Preoperative factors known to influence 5-year transplant survival influenced ABCFS after 1 year of follow-up. The 1-year ABCFS was indicative of 5-year transplant survival. ABCFS is a reproducible metric to evaluate the results of LT after 1 year of follow-up and could serve as a new endpoint in clinical trials.

中文翻译:

用于评估肝移植结果的新型复合终点:无动脉和胆道并发症的生存期

移植和患者存活是评估肝移植 (LT) 成功与否的有效终点。本研究将动脉和胆道无并发症生存期 (ABCFS) 作为一项新指标进行评估。ABC 被视为一个事件,是 Dindo-Clavien ≥ III 级并发症的动脉或胆道并发症,发生在需要介入、内窥镜或手术治疗以纠正它时。ABCFS 被定义为从 LT 日期到第一次 ABC、死亡、重新上市或最后一次随访日期的时间(移植存活是从 LT 到重复 LT 或死亡的时间)。在初次全 LT (n = 532) 之后,发生了 106 次 ABC,其中 99 次 (93%) 发生在 LT 后的第一年。LT 后第一年发生的 ABC(总发生率为 19%)是与移植存活相关的独立因素(风险比 [HR],3.17;P  < 0.001) 和患者存活率 (HR, 2.7; P  = 0.002) 在单变量和多变量分析中。这一结果在队列扩展至分裂肝移植、循环死亡后捐献或重新 LT (n = 658) 后得到证实。来自 2 个外部原发性完整 LT 队列(分别为 n = 249 和 229)的数据证实,第一年 ABC 是移植存活率而非患者存活率的独立预后因素。ABCFS 与移植和患者存活相关(ρ = 0.85 [95% CI,0.78-0.90] 和 0.81 [95% CI,0.71-0.88]。已知影响 5 年移植存活率的术前因素在 1 年随访后影响 ABCFS。1 年 ABCFS 表明 5 年移植存活率。ABCFS 是一种可重复的指标,用于评估 LT 随访 1 年后的结果,并可作为临床试验的新终点。
更新日期:2021-08-17
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