DCD Heart
Trial question
Is heart transplantation from donors after circulatory death noninferior to heart transplantation from donors after brain death?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
27.0% female
73.0% male
N = 180
180 patients (48 female, 132 male).
Inclusion criteria: primary adult candidates for heart transplantation.
Key exclusion criteria: recipients who were candidates for multiorgan transplantation; history of solid-organ or bone marrow transplantation; chronic renal failure, and receipt of hemodialysis.
Interventions
N=90 circulatory-death (receipt of heart after circulatory death of the donor or a heart from a donor after brain death if that heart was available first).
N=90 brain-death (receipt of only a heart that had been preserved with the use of traditional cold storage after the brain death of the donor).
Primary outcome
Risk-adjusted survival at 6 months
94%
90%
94.0 %
70.5 %
47.0 %
23.5 %
0.0 %
Circulatory-death
Brain-death
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in risk-adjusted survival at 6 months (94% vs. 90%; MD -3, 90% CI -10 to 3).
Safety outcomes
No significant difference in mean per-patient number of serious adverse events associated with heart graft at 30 days after transplantation.
Conclusion
In primary adult candidates for heart transplantation, circulatory-death was noninferior to brain-death with respect to a risk-adjusted survival at 6 months.
Reference
Jacob N Schroder, Chetan B Patel, Adam D DeVore et al. Transplantation Outcomes with Donor Hearts after Circulatory Death. N Engl J Med. 2023 Jun 8;388(23):2121-2131.
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