Wound complications and surgical events in de novo heart transplant patients treated with everolimus: Post-hoc analysis of the SCHEDULE trial

Rashidi, Mitra; Esmaily, S.; Fiane, Arnt E.; Gude, Einar; Tønseth, Kim Alexander; Ueland, Thor; Gustafsson, Finn; Eiskjær, Hans; Rådegran, Göran; Dellgren, Göran

doi:10.1016/j.ijcard.2016.02.075

Cited by 10 publications

(2 citation statements)

References 14 publications

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“…Similar findings are seen with a tacrolimus‐based platform . Everolimus has been associated with delayed wound healing, and most recommend to delay initiation of this drug beyond the period of wound healing to avoid complications . Use of everolimus allows marked reduction in calcineurin trough levels or complete avoidance of calcineurin antagonists, leading to improved renal function.…”

mentioning

confidence: 65%

Rejection: the emperor’s new clothes

Baran

2020

Transpl Int

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mentioning

confidence: 65%

Rejection: the emperor’s new clothes

Baran

2020

Transpl Int

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“…19,20 However, a recent post hoc analysis of patients in the SCHEDULE trial found no difference in adverse wound healing events between patients on everolimus as compared to cyclosporine. 21 Similarly, an analysis that pooled the data from 3 clinical trials found no increase in wound healing events in patients with everolimus at 1.5 mg compared with MPA, whereas patients treated with everolimus at 3 mg did have more wound healing events than MPA. 8 At this point, it is important to differentiate the roles that inhibitor dose and derivative use play in wound healing complications.…”

Section: Discussionmentioning

confidence: 99%

mTOR Inhibition by Everolimus Does Not Impair Closure of Punch Biopsy Wounds in Renal Transplant Patients

Dutt

Gonzales

Boyett

et al. 2017

Transplantation Direct

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BackgroundMammalian target of rapamycin (mTOR) inhibitors are approved to prevent allograft rejection and control malignancy. Unfortunately, they are associated with adverse effects, such as wound healing complications that detract from more extensive use. There is a lack of prospective wound healing studies to monitor patients treated with mTOR inhibitors, such as everolimus or sirolimus, especially in nondiabetics.MethodsPatients receiving everolimus with standard immunosuppressant therapy or standard immunosuppressant therapy without everolimus were administered 3-mm skin biopsy punch wounds in the left scapular region. Homeostatic gene expression was examined in the skin obtained from the biopsy and wound surface area was examined on day 7. Peripheral blood mononuclear cells were examined for cytokine production.ResultsThere are no significant changes in autophagy related 13, epidermal growth factor, insulin-like growth factor binding protein 3, IL-2, kruppel-like factor 4, and TGFB1 gene expression in the skin suggesting that there is little impact of everolimus on these genes within nonwounded skin. Peripheral blood T cells are more sensitive to cell death in everolimus-treated patients, but they retain the ability to produce proinflammatory cytokines required for efficient wound repair. Importantly, there is no delay in the closure of biopsy wounds in patients receiving everolimus as compared to those not receiving mTOR inhibition.ConclusionsEverolimus treatment is not associated with impaired closure of skin biopsy wounds in kidney transplant recipients. These data highlight the importance of exploring whether larger surgical wounds would show a similar result and how other factors, such as diabetes, impact wound healing complications associated with mTOR suppression.

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