Randomised controlled trial
Transplantation Outcomes with Donor Hearts after Circulatory Death
- Randomised controlled trial
- non-inferiority
- 3:1 randomisation
Authors' conclusion
In this trial, risk-adjusted survival at 6 months after transplantation with a donor heart that had been reanimated and assessed with the use of extracorporeal nonischemic perfusion after circulatory death was not inferior to that after standard-care transplantation with a donor heart that had been preserved with the use of cold storage after brain death.
Study context
- Population
- Adult candidates for heart transplantation166 in as-treated analysis
- Participants
- 180 candidates
- Comparison
- Donor hearts after circulatory death vs after brain death
- Primary endpoint
- Risk-adjusted survival (as-treated)
- Follow-up
- 6 months
Primary result
Risk-adjusted survival
Least-squares mean difference
−3 percentage points
90% CI −10 to 3
P < 0.001 for non-inferiority
By group
Non-inferiority margin 20 as printed, not drawn
As reported in the abstract
Safety
Serious adverse events associated with the heart graft (mean per patient) · 30 days after transplantation
- No substantial between-group differences
- primary safety end point
Original publication
Summarised from the published abstract; every number is checked against it