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dc.contributor.authorArora, Satish
dc.contributor.authorAndreassen, Arne K.
dc.contributor.authorKarason, Kristjan
dc.contributor.authorGustafsson, Finn
dc.contributor.authorEiskjær, Hans
dc.contributor.authorBøtker, Hans Erik
dc.contributor.authorRådegran, Göran
dc.contributor.authorGude, Einar
dc.contributor.authorIoanes, Dan
dc.contributor.authorSolbu, Dag
dc.contributor.authorDellgren, Göran
dc.contributor.authorUeland, Thor
dc.contributor.authorAukrust, Pål
dc.contributor.authorGullestad, Lars
dc.date.accessioned2019-03-12T14:08:47Z
dc.date.available2019-03-12T14:08:47Z
dc.date.issued2018-09-07
dc.description.abstract<i>Background</i>: Cardiac allograft vasculopathy (CAV) limits survival after heart transplantation, and the effect of different immunosuppressive regimens on CAV is not fully understood. The randomized SCHEDULE trial (Scandinavian Heart Transplant Everolimus De Novo Study With Early Calcineurin Inhibitors Avoidance) evaluated whether initiation of the proliferation signal inhibitor everolimus and early cyclosporine elimination can reduce CAV development.<p> <p><i>Methods and results</i>: The SCHEDULE trial was a multicenter Scandinavian trial, where 115 de novo heart transplantation recipients were randomized to everolimus with complete cyclosporine withdrawal 7 to 11 weeks after heart transplantation or standard cyclosporinebased immunosuppression. Seventy-six (66%) patients had matched intravascular ultrasound examinations at baseline and 12 and 36 months. Intravascular ultrasound analysis evaluated maximal intimal thickness, percent atheroma volume, and total atheroma volume. Qualitative plaque analysis using virtual histology assessed fibrous, fibrofatty, and calcified tissue as well as necrotic core. Serum inflammatory markers were measured in parallel. The everolimus group (n=37) demonstrated significantly reduced CAV progression as compared with the cyclosporine group (n=39) at 36 months (∆ maximal intimal thickness, 0.09±0.05 versus 0.15±0.16 mm [<i>P</i>=0.03]; ∆ percent atheroma volume, 5.3±2.8% versus 7.6±5.9% [P=0.03]; and ∆ total atheroma volume, 33.9±71.2 versus 54.2±96.0 mm3 [P=0.34], respectively]. At 36 months the number of everolimus patients with rejection graded ≥2R was 15 (41%) as compared with 5 (13%) in the cyclosporine group (P=0.01). Everolimus did not affect CAV morphology or immune marker activity during the follow-up period.<p> <p><i>Conclusions</i>: The SCHEDULE trial demonstrates that everolimus initiation and early cyclosporine elimination significantly reduces CAV progression at 12 months, and this beneficial effect is clearly sustained at 36 months.en_US
dc.description.sponsorshipNovartis Scandinaviaen_US
dc.descriptionAccepted manuscript version. Published version available at <a href=https://doi.org/10.1161/CIRCHEARTFAILURE.117.004050>https://doi.org/10.1161/CIRCHEARTFAILURE.117.004050. </a>en_US
dc.identifier.citationArora, S., Andreassen, A.K., Karason, K., Gustafsson, F., Eiskjær, H., Bøtker, H.E. ... Gullestad, L. (2018). Effect of everolimus initiation and calcineurin inhibitor elimination on cardiac allograft vasculopathy in de novo heart transplant recipients - Three-year results of a Scandinavian randomized trial. <i>Circulation: Heart Failure, 11</i>(9), e004050. https://doi.org/10.1161/CIRCHEARTFAILURE.117.004050en_US
dc.identifier.cristinIDFRIDAID 1647877
dc.identifier.doi10.1161/CIRCHEARTFAILURE.117.004050
dc.identifier.issn1941-3289
dc.identifier.issn1941-3297
dc.identifier.urihttps://hdl.handle.net/10037/14957
dc.language.isoengen_US
dc.publisherAmerican Heart Association
dc.relation.journalCirculation: Heart Failure
dc.rights.accessRightsopenAccessen_US
dc.subjectallograften_US
dc.subjectcalcineurin inhibitorsen_US
dc.subjectcyclosporineen_US
dc.subjecteverolimusen_US
dc.subjectheart transplantationen_US
dc.subjectVDP::Medical disciplines: 700::Clinical medical disciplines: 750en_US
dc.subjectVDP::Medisinske Fag: 700::Klinisk medisinske fag: 750en_US
dc.titleEffect of everolimus initiation and calcineurin inhibitor elimination on cardiac allograft vasculopathy in de novo heart transplant recipients - Three-Year results of a Scandinavian randomized trialen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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