Key result
Everolimus reduces SBP by ~13 mmHg versus cyclosporine in de novo heart transplant recipients.
Why the study?
Systemic hypertension is prevalent in heart transplant recipients and has been partially attributed to treatment with calcineurin inhibitors, but randomized data comparing blood pressure effects of everolimus-based versus CNI-based regimens were lacking.
Does an everolimus-based immunosuppressive regimen reduce blood pressure compared to a cyclosporine-based regimen in de novo heart transplant recipients?
RCT
Randomized
Does an everolimus-based immunosuppressive regimen reduce blood pressure compared to a cyclosporine-based regimen in de novo heart transplant recipients?
Mean Difference: 13 (95% CI 2–23)
Absolute Event Rate: -13% vs 0%
p-value: p=0.02
Early withdrawal of calcineurin inhibitors and replacement with an everolimus-based regimen significantly reduces systolic blood pressure at 3 years in de novo heart transplant recipients.
Supports everolimus-based regimens to lower blood pressure after heart transplantation; extends evidence for early CNI-sparing strategies.
BACKGROUND: Systemic hypertension is prevalent in heart transplant recipients and has been partially attributed to treatment with calcineurin inhibitors (CNIs). SCandinavian HEart transplant De-novo stUdy with earLy calcineurin inhibitors avoidancE trial was the first randomized trial to study early withdrawal of CNIs in de novo heart transplant recipients, comparing an everolimus-based immunosuppressive regimen with conventional CNI-based treatment. As a prespecified secondary endpoint, blood pressure was repeatedly compared across treatment arms. METHODS: The The SCandinavian HEart transplant De-novo stUdy with earLy calcineurin inhibitors avoidancE trial was a prospective, multicenter, randomized, controlled, parallel-group, open-label trial in de novo adult heart transplant recipients, undertaken at transplant centers in Scandinavia. Blood pressure was assessed with 24-hour ambulatory blood pressure monitoring up to 3 years after heart transplantation (HTx) in 83 patients. RESULTS: Overall, systolic blood pressure fell with time, from 138 ± 15 mm Hg 2 weeks after HTx to 134 ± 11 mm Hg after 12 months and 132 ± 14 mm Hg after 36 months (P = 0.003). Diastolic blood pressure did not change over time. After 12 months, there was a numerically larger fall in systolic blood pressure in the everolimus arm (between-group difference 8 mm Hg; P = 0.053), and after 36 months, there was a significant between group difference of 13 mm Hg (P = 0.02) in favor of everolimus. CONCLUSIONS: In this first, randomized trial with early CNI avoidance in de novo HTx recipients, we observed a modest fall in systolic blood pressure over the first 1 to 3 years after transplantation. The fall in systolic blood pressure was more pronounced in patients allocated to everolimus.
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Broch et al. (2018) conducted an RCT in De Novo Heart Transplant. Everolimus vs. Cyclosporine-based regimen was evaluated on Difference in systolic blood pressure (SBP) from 2 weeks to 36 months (MD 13, 95% CI 2-23, p=0.02). In de novo heart transplant recipients, treatment with everolimus significantly reduced systolic blood pressure from 2 weeks to 36 months by 13 mmHg compared to a cyclosporine-based regimen.
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