Key result
Sirolimus cuts grade 3A or greater acute rejection ~43% vs. azathioprine after transplantation.
Why the study?
The effects of sirolimus on acute rejection and transplant vasculopathy in human heart transplant recipients were unknown.
Does sirolimus reduce acute rejection and prevent transplant vasculopathy in de novo heart transplant recipients compared to azathioprine?
Population
136 cardiac allograft recipients
Comparison
Sirolimus vs azathioprine in combination with cyclosporine and steroids
Design
Randomized open-label study with 2:1 randomization
Follow-up
2 years
Authors
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Sirolimus may lower early rejection after transplantation; leaves open its role versus azathioprine pending randomized trials.
RCT (n=136)
Open-label
2:1
Does sirolimus reduce acute rejection and prevent transplant vasculopathy in de novo heart transplant recipients compared to azathioprine?
Absolute Event Rate: 32.4% vs 56.8%
p-value: p=0.027
Sirolimus significantly reduces acute rejection and prevents the progression of transplant vasculopathy at up to 2 years compared to azathioprine in de novo heart transplant recipients.
Keogh et al. (2004) conducted an RCT in De novo heart transplant (n=136). Sirolimus vs. Azathioprine was evaluated on 6-month rejection rates (grade 3a or greater acute rejection) (p=0.027). Sirolimus use from the time of transplantation significantly reduced the 6-month rate of grade 3a or greater acute rejection compared to azathioprine (32.4% for 3 mg/d vs 56.8%; P=0.027).
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