Abstract
The SCHEDULE (Scandinavian heart transplant everolimus de-novo study with early calcineurin inhibitors avoidance) trial has sought to evaluate whether initiation of the proliferation signal inhibitor everolimus and total early cyclosporine elimination can significantly reduce the development of CAV in de-novo HTx recipients. We have previously reported that patients treated with everolimus demonstrated significantly reduced CAV progression when compared to cyclosporine therapy at both 12 and 36 months (12-month IVUS examination revealed ∆Maximal Intimal Thickness (MIT) 0.02±0.05 versus 0.08±0.12 mm (p<0.01), ∆Percent Atheroma Volume (PAV) 1.2±2.0 versus 3.7±4.1% (p<0.01), ∆Total Atheroma Volume (TAV) -0.13±20.5 mm3 versus 11.1±27.6 mm3 (p=0.08) and 36-month examination showed ∆MlT 0.09±0.05 versus 0.15±0.16 mm (p=0.01), ∆PAV 5.4±3.1 versus 7.6±5.9% (p=0.02), ∆TAV 33.9±71.2 mm3 versus 54.2±96.0 mm3 (p=0.26), respectively). Treatment according to study arm has been further extended to a total treatment period of 6 years and the IVUS results of this follow-up period will be presented. In addition, Virtual Histology (VH) data will be included to assess the morphological changes associated with everolimus treatment.
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