Virtual Histology Assessment of Cardiac Allograft Vasculopathy Following Introduction of Everolimus-Results of a Multicenter Trial.
Arora S, Erikstad I, et al.American Journal of Transplantation 2012; 12(10):2700-2709.
Aims
This sub-study of the NOCTET trial aimed to evaluate the influence of everolimus on cardiac allograft vasculopathy (CAV) morphology using virtual histology (VH) assessment.
Interventions
Everolimus with reduced calcineurin inhibitor (CNI) exposure versus continued standard CNI therapy.
Participants
78 heart transplant recipients who were enrolled in NOCTET trial and had matching VH examination recordings at baseline and follow-up.
Outcomes
The parameters of CAV morphology included Intima volume, plaque index, fibrous component, fibrofatty component, calcified component and necrotic component. Markers of inflammation and endothelial cell activation were levels of vWF, CRP and VCAM-1.
Follow-up
12 month
CET Conclusions
In this sub-study of the NOCTET trial which included 190 heart transplant recipients, 78 patients were the Virtual Histology study population. 30 of these patients received everolimus together with low dose CNI therapy while 48 patients were receiving standard CNI therapy. The Virtual Histology is a novel technique using images obtained from the intravenous ultrasound during pull back allowing a tissue map of the coronary arteries to be constructed. Results at varying times after transplantation suggested that in patients receiving everolimus there was a significant increase in calcified and necrotic tissue components and this was associated with an increase in vWF and VCAM levels, all of which suggest an unknown influence by everolimus on these inflammatory pathways. These are very interesting observations which obviously deserve further studies.
Data analysis
Per protocol analysis
Trial registration
NCT00377962 (ClinicalTrials.gov)