Blood Pressure in De novo Heart Transplant Recipients Treated with Everolimus Compared with a Cyclosporine-Based Regimen: Results from the Randomized SCHEDULE Trial

Background Systemic hypertension is prevalent in heart transplant recipients, and has been partially attributed to treatment with calcineurin inhibitors (CNIs). The SCHEDULE 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 SCHEDULE 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 HTx in 83 patients. Results Overall, systolic blood pressure fell with time, from 138 ± 15 mmHg 2 weeks after HTx to 134 ± 11 mmHg after 12 months and 132 ± 14 mmHg 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 mmHg; p = 0.053), and after 36 months, there was a significant between group difference of 13 mmHg (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 – 3 years after transplantation. The fall in systolic blood pressure was more pronounced in patients allocated to everolimus. Clinical trial registration: ClinicalTrials.gov (NCT01266148) at https://ift.tt/KkipBP Address for correspondence: Arne K. Andreassen, Department of Cardiology, Oslo University Hospital Rikshospitalet, PO Box 4950 Nydalen, 0424 Oslo, Norway. Phone +47230700. aandreas@ous-hf.no Authorship statement AK Andreassen participated in research design, performance of the research, writing of the manuscript, and critical revision of the manuscript for important intellectual content K Broch participated in writing of the manuscript, performance of the research, data analysis, and critical revision of the manuscript for important intellectual content H Eiskjær participated in research design, performance of the research, and critical revision of the manuscript for important intellectual content K Karason participated in research design, performance of the research, and critical revision of the manuscript for important intellectual content E Gude participated in research design, performance of the research, and critical revision of the manuscript for important intellectual content D Mølbak participated in performance of the research, and critical revision of the manuscript for important intellectual content W Stueflotten participated in performance of the research, and critical revision of the manuscript for important intellectual content L Gullestad participated in research design, performance of the research, and critical revision of the manuscript for important intellectual content Disclosure: The authors declare no conflicts of interest. Funding: The SCHEDULE trial was funded by Novartis Scandinavia. The funding source had no role in the design of the study, in the analyses of the results, or in the decision to publish. Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.

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