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

International Journal of Cardiology 2016; 210: 80-84.

Aims
To compare wound complications between everolimus (EVE) and calcineurin (CNI) based regimens using results from the Scandinavian heart transplant (HTx) EVE de novo trial with early CNI avoidance (SCHEDULE) trial*.

Interventions
Participants were randomized within five days post-HTx to low dose EVE and reduced dose Cyclosporine (CyA) followed by CyA withdrawal week 7–11 post-HTx (EVE group), versus standard CyA regimen (CyA group).

Participants
115 HTx recipients from the SCHEDULE trial.

Outcomes
The primary measured outcome was the number of wound complications. The secondary measured outcome was the rate of total surgical events.

Follow-up
12 months

CET Conclusions
This is a retrospective analysis of the SCHEDULE trial, which compared everolimus versus standard calcineurin inhibitor (CNI) in 115 heart transplant recipients. The retrospective analysis evaluated wound complications and surgical events in the first 12 months posttransplant. Low-dose everolimus was started within five days posttransplant followed by gradual CNI withdrawal and increased everolimus together with MMF and corticosteroids. Data were prospectively collected and retrospectively re-assessed by two independent, unblinded reviewers. A surgical event was defined as any adverse or serious adverse event requiring operative intervention and wound complications as any complication associated with failure of tissue healing such as chronic wound infection, need of antibiotics, wound dehiscence and chronic fistulas. Most complications occurred in the first 2 weeks posttransplant with 30% of the study population experiencing would complications. There were no significant differences between the groups for wound complications or surgical events.

Jadad score
2

Data analysis
Available case analysis

Allocation concealment
Yes

Quality notes
Previously assessed as *AndreassenA.K. et al, SCHEDULE Investigators. Everolimus initiation and early calcineurin inhibitor withdrawal in heart transplant recipients: a randomized trial. Everolimus initiation and early calcineurin inhibitor withdrawal in heart transplant recipients: a randomized trial, Am J Transplant 2014; 14(8):1828–1838

Trial registration
ClinicalTrials.gov - NCT01266148

Funding source
No funding received