Date: Saturday, June 1, 2019
Session Time: 5:30pm-7:30pm
Presentation Time: 5:30pm-7:30pm
Location: Hall C & D
*Purpose: The standard immunosuppressive regimen used for younger patients may not be adequate for the elderly cohort.
*Methods: The nEverOld is a prospective, single-center, randomized trial comparing EVL/ low tacrolimus exposure (EVL n=53) with sodium mycophenolate /standard TAC/ (MPS n=47) in elderly (≥60y) recipients (baseline: 65±4y, 60-78y).In the EVL arm, MPS was switched to EVL after the 1st month.A single 2mg/kg ATG dose was given as induction. CMV prophylaxis for 90 days was given for the MPS group only and protocol biopsies performed at the end of each year. Primary efficacy end-point (PEP) was a composite of first occurrence of death, graft loss or measured GFR<50ml/min/1.73m2 at the end of 1st year. Secondary end-points were rejection rate and long-term serious adverse (safety). Data was analyzed as ITT.
*Results: Baseline characteristics were very similar with a high rate of comorbidities. The primary end-point occurred in 32 and 34% of EVL and MPS groups, respectively (p=ns). By per-protocol analysis (after conversion), 23 and 28% of the EVL and MPS arms reached the PEP (p=ns). After a mean follow-up of 47±14 months, bx-proven acute rejection throughout the study period, was diagnosed in 15 (28%) and 12 (26%) of the EVL and MPS groups (73% borderline). 4-y patient survival (66%) was similar between groups. eGFR was also very similar in both groups (~47±15 ml/min/1.73m2) during the whole follow-up period. There were differences in the profile of serious adverse events (SAEs). By Kaplan-Meier estimates, deep venous thrombosis (20×6%, p=0.069) and UTI requiring hospitalization (30×20%,p=0.112) tended to be more frequent in the EVL group. On the other side, Herpes zoster infection (0x36%,p=0.009) and non-skin cancers (2×14%,p=0.084) presented a lower incidence in the EVL group. There was also a trend to less CMV disease even without prophylaxis (7×15%, p=0.295) and clinically-diagnosed dementia syndrome (11×31%,p=0.147) in the EVL group. The dementia syndrome is being currently investigated by amyloid- β PET-Scan.
*Conclusions: These data indicate that, in the elderly kidney transplant recipient, the IS regimen consisted of EVL/ low exposure tacrolimus presents the same long-term efficacy as MPS/standard tacrolimus. However, the long-term safety seems to favour EVL/low tacrolimus regimen. The main long-term SAEs in the EVL group (UTI, DVP) are feasible to be prevented but those in the MPS group(non-skin cancer and dementia) are not.
To cite this abstract in AMA style:David-Neto E, Agena F, Paula FJ, Galante NZ, David DS, Ramos F, Triboni AK, Romano P, Ebner PA, Coelho V, Altona M, Falci R, Piovesan A, Nahas WC. Everolimus/Low Tacrolimus Exposure versus Sodium Mycophenolate/Standard Tacrolimus for the Elderly Kidney Transplant Recipient. A 4-y Follow-Up of the nEverOld Trial [abstract]. Am J Transplant. 2019; 19 (suppl 3). https://atcmeetingabstracts.com/abstract/everolimus-low-tacrolimus-exposure-versus-sodium-mycophenolate-standard-tacrolimus-for-the-elderly-kidney-transplant-recipient-a-4-y-follow-up-of-the-neverold-trial/. Accessed April 15, 2021.
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