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Blood Pressure in De Novo Heart Transplant Recipients Treated With Everolimus Compared With a Cyclosporine-based Regimen

Results From the Randomized SCHEDULE Trial

Andreassen, Arne K., MD, PhD1,2; Broch, Kaspar, MD, PhD1; Eiskjær, Hans, MD, PhD3; Karason, Kristjan, MD, PhD4; Gude, Einar, MD, PhD1; Mølbak, Dorte, RN3; Stueflotten, Wenche, RN1; Gullestad, Lars, MD, PhD1,2 on behalf of the SCHEDULE (SCandinavian HEart transplant everolimus De-novo stUdy with earLy calcineurin inhibitors avoidancE) Investigators

doi: 10.1097/TP.0000000000002445
Original Clinical Science—General
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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.

1 Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.

2 Faculty of Medicine, University of Oslo, Oslo, Norway.

3 Department of Cardiology, Aarhus University Hospital, Skejby, Denmark.

4 Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.

Received 14 May 2018. Revision received 31 July 2018.

Accepted 21 August 2018.

The authors declare no conflicts of interest.

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.

A.K.A. participated in research design, performance of the research, writing of the article, and critical revision of the article for important intellectual content. K.B. participated in writing of the article, performance of the research, data analysis, and critical revision of the article for important intellectual content. H.E. participated in research design, performance of the research, and critical revision of the article for important intellectual content. K.K. participated in research design, performance of the research, and critical revision of the article for important intellectual content. E.G. participated in research design, performance of the research, and critical revision of the article for important intellectual content. D.M. participated in performance of the research, and critical revision of the article for important intellectual content. W.S. participated in performance of the research, and critical revision of the article for important intellectual content. L.G. participated in research design, performance of the research, and critical revision of the article for important intellectual content.

ClinicalTrials.gov (NCT01266148) at http://clinicaltrials.gov/.

Supplemental digital content (SDC) is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal’s Web site (www.transplantjournal.com).

Correspondence: Arne K. Andreassen, MD, Department of Cardiology, Oslo University Hospital Rikshospitalet, PO Box 4950 Nydalen, 0424 Oslo, Norway. (aandreas@ous-hf.no).

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