Heart failure & cardiomyopathiesRandomised controlled trial
Everolimus and Low-Dose Tacrolimus After Heart Transplant in Children
- Randomised controlled trial
- multicentre
- open-label
- noninferiority (safety)
Authors' conclusion
Among 6-month pediatric heart transplant survivors, everolimus and low-dose tacrolimus did not differ from tacrolimus and mycophenolate in preventing the composite of cellular rejection, CAV, and CKD at 30 months.
Study context
- Population
- Children alive 6 months after heart transplant, 25 US sites, 2018–2020
- Participants
- 211 participants
- Comparison
- Everolimus vs Mycophenolate
- Everolimusn = 107
- Mycophenolaten = 104reference
- Primary endpoint
- MATE-3 score (composite ordinal:
- Acute cellular rejection
- Cardiac allograft vasculopathy (CAV)
- Chronic kidney disease (CKD))
- Primary safety end point MATE-6 score
- Follow-up
- 30 months
Primary result
As reported in the abstract
MATE-3 score
Mean MATE-3 score did not differ between the 2 treatment groups (mean difference, −0.32; 95% CI, −0.90 to 0.20)
P = .16
Further findings
| Outcome | mean difference (mL/min/1.73 m²) (95% CI) | |
|---|---|---|
| Improvement in eGFR · 12 months | 10.5 (1.09–19.91) | |
| −1001020Difference, mL/min/1.73 m² (linear scale) |
| Outcome | HR (95% CI) | |
|---|---|---|
| CMV infection | 0.50 (0.26–0.93) | |
| 0.20.5125Hazard ratio (log scale) |
Graft survival, MATE-free survival, freedom from any individual MATE
- No differences
Safety
| Outcome | baseline-adjusted mean difference (95% CI) | |
|---|---|---|
| MATE-6 score (primary safety end point) · meeting the success criterion for safety | −0.40 (−1.81 to 0.93) | |
| −2−101Difference (linear scale) |
- MATE-6 score (primary safety end point): noninferiority margin <3
Original publication
Everolimus and Low-Dose Tacrolimus After Heart Transplant in Children. JAMA. Published 21 October 2025. doi:10.1001/jama.2025.14338
Summarised from the published abstract; every number is checked against it