Heart failure & cardiomyopathies
Everolimus and Low-Dose Tacrolimus After Heart Transplant in Children: A Randomized Clinical Trial
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 + low-dose tacrolimus vs standard-dose tacrolimus + mycophenolate mofetil
- 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
Methodological detailsmulticentre, open-label, noninferiority (safety)
- Multicentre
- Open-label
- Noninferiority (safety)
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: A Randomized Clinical Trial. JAMA. Published 21 October 2025. doi:10.
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