Wound healing complications in kidney transplant recipients receiving everolimus.
Ueno P, Felipe C, et al.Transplantation 2016 [record in progress].
Aims
To perform a sub-analysis to compare the incidence of wound healing adverse events (WHAE) in patients receiving everolimus (EVR) or mycophenolate sodium (MPS).
Interventions
Participants were randomized to one of three different regimens and received either, rabbit anti-thymocyte globulin (r-ATG) followed by tacrolimus (TAC), EVR and prednisone (r-ATG/EVR group), versus basiliximab (BAS), TAC and prednisone (BAS/EVR group), versus BAS, TAC, MPS and prednisone (BAS/MPS group).
Participants
288 recipients of living or deceased donor kidney transplants.
Outcomes
The primary outcome measured was the incidence of patients with at least one clinical WHAE. Secondary outcomes included the incidence of patients who required surgical intervention due to WHAE, subclinical WHAE, total incidence of clinical and subclinical WHAE, and risk factors associated with the development of WHAE.
Follow-up
12 months
CET Conclusions
This was a prespecified subgroup analysis of an RCT comparing rATG/everolimus, basiliximab/everolimus and basiliximab/mycophenolate sodium (MPS) in living or deceased donor kidney transplants with maintenance immunosuppression being tacrolimus and prednisone. The subgroup analysis evaluated wound healing adverse events, which were assessed by a dedicated physician during hospital stay and at the outpatient clinic. Subclinical wound healing adverse events were detected by abdominal ultrasound at 30 days posttransplant. It is unclear from the report whether these clinical and subclinical assessments were done blindly. There were significant differences between the basiliximab/everolimus and basiliximab/MPS groups for the number of patients presenting with at least one wound complication, incidence of subclinical wound complications and cumulative incidence of clinical and subclinical wound healing complications but not for the other wound healing outcomes. The percentage of patients requiring re-interventions was similar between groups. Multivariable logistic regression analysis showed no significant association between clinical variables and wound healing adverse events. This explorative, unpowered subgroup analysis showed similar results as previously reported namely a possible increased incidence of wound healing adverse events when everolimus is administered from the time of transplantation.
Data analysis
Modified intention-to-treat analysis
Quality notes
Previously assessed as Tedescoâ€Silva H, et al. Reduced Incidence of Cytomegalovirus Infection in Kidney Transplant Recipients Receiving Everolimus and Reduced Tacrolimus Doses. Am J Transplant. 2015; 15: 2655–2664.
Trial registration
ClinicalTrials.gov - NCT01354301