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Change in Maximum Intimal Thickness with Everolimus-Based Immunosuppression after Heart Transplantation in Patients at Increased Risk of Cardiac Allograft Vasculopathy
Journal article   Peer reviewed

Change in Maximum Intimal Thickness with Everolimus-Based Immunosuppression after Heart Transplantation in Patients at Increased Risk of Cardiac Allograft Vasculopathy

J. Kobashigawa, R. Starling, G. Dong, P. Lopez and H.J. Eisen
The Journal of heart and lung transplantation, v 32(4), pp S25-S26
Apr 2013
DOI: https://doi.org/10.1016/j.healun.2013.01.047

Abstract

Heart transplant (HTx) patients (pts) on everolimus(EVR) have less change in maximum intimal thickness (MIT) over 12 m in the A2310 and B253 studies compared to pts on mycophenolate mofetil (MMF) or azathioprine (AZA). In A2310 this benefit was also seen in distinct pt subpopulations at increased risk of cardiac allograft vasculopathy (CAV). The purpose of the current study was to determine the effect of EVR on MIT change in the B253 study. B253 was a randomized, 24m (12m double-blind), multicenter study comparing fixed-dose EVR (1.5mg or 3mg/day) to AZA (1-3mg/kg/day) with cyclosporine (CsA) and corticosteroids in 634 pts. The IVUS substudy included 211 pts. MIT was analyzed retrospectively for pt subgroups divided by age, gender, presence of diabetes, presence of donor disease (MIT≥0.5 mm at baseline (BL)), and based on Time-normalized lipid profiles. Results were compared to results from A2310. As in A2310, average MIT change from baseline to 12m was smaller in the EVR 1.5mg arm of study B253 for pts who were ≥50 years, male, diabetic, had donor disease, high triglycerides, or low HDL (Table). MIT change in pts with high total cholesterol was comparable in EVR 1.5mg and AZA, whereas in A2310 it had been smaller for the EVR group (Table). HTx subgroups at increased risk of CAV treated with EVR in study B253 had less increase in MIT. Although EVR is known to raise lipid levels, there was either less or comparable change in MIT with EVR. These results confirm the findings from study A2310. Mean change in MIT (mm) from baseline to M12Study B253Study A2310Baseline characteristicEVR 1.5mg (n=88)AZA (n=101)EVR 1.5mg (n=70)MMF (N=72)Age ≥ 50 years0.040.150.030.08Male gender0.030.110.030.07Diabetes0.060.090.040.08Donor disease-0.10-0.050.030.09Time-normalized lipids categorized by AHA classificationEVR 1.5mgAZAEVR 1.5mgMMFHigh total cholesterol0.050.060.040.15Low HDL-C0.020.050.020.10High triglycerides0.040.130.030.10

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Collaboration types
Industry collaboration
Domestic collaboration
International collaboration
Web of Science research areas
Cardiac & Cardiovascular Systems
Respiratory System
Surgery
Transplantation
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