BIOLOGIC AND THERAPEUTIC ADVANCES IN HEART TRANSPLANTATION I

M.G. Crespo-leiro¹, A. Zuckermann², A. Keogh³, D. Mancini⁴, F. González-vilchez⁵, L. Almenar⁶, S. Brozena⁷, H. Eisen⁸, S. See tai⁹, S. Kushwaha^10
1Unidad De Insuficiencia Cardiaca Avanzada Y Trasplante Cardiaco, Hospital Universitario A Coruña, La Coruña/SPAIN, ²Dept. Of Cardiothoracic Surgery, Medical University of Vienna, Vienna/AUSTRIA, ³, St. Vincent's Hospital, Sydney/AUSTRALIA, ⁴, Columbia University Medical Center, New York/UNITED STATES OF AMERICA, ⁵, Hospital Marques de Valdecilla, Santander/SPAIN, ⁶, Hospital La Fe, Valencia/SPAIN, ⁷, University of Pennsylvania, Philadelphia/UNITED STATES OF AMERICA, ⁸, Drexel University College of Medicine, Philadelphia/PA/UNITED STATES OF AMERICA, ⁹, Pfizer Inc., Collegeville/UNITED STATES OF AMERICA, ¹⁰, Mayo Clinic Rochester, Rochester/UNITED STATES OF AMERICA

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Introduction: Cardiac transplant recipients can develop renal insufficiency related to CNI nephrotoxicity. This study evaluates the effect of converting from CNIs to sirolimus on renal function in cardiac transplant recipients with mild to moderate renal dysfunction.

Methods: This ongoing, prospective, randomized, phase 4 study is being conducted in Australia, Europe, New Zealand, and North America. Adult cardiac transplant recipients (n=116) were randomly assigned to either convert from CNIs to sirolimus (n=57) or continue with CNIs (n=59). Eligible patients were 1 to 8 years posttransplant, receiving a CNI-based regimen, and with GFR >40 but <90 mL/min/1.73m². Patients with acute rejection within 3 months or proteinuria >500 mg/day were excluded. Safety assessment included a protocol-mandated biopsy only in patients converted to sirolimus. The primary endpoint is change from baseline in calculated creatinine clearance (Cockcroft-Gault) at 1 year.

Results: Demographic characteristics were similar between groups (see Table). Overall, the mean time since transplant was 3.9 years. Ischemic cardiomyopathy (48.3%) and idiopathic cardiomyopathy (44.8%) were the main reasons for transplant. Six-month interim data will be presented.
Conclusions: The results from this clinical trial may help clarify whether conversion to sirolimus-based therapy is associated with improved renal function in cardiac transplant patients with mild to moderate renal insufficiency.

Disclosure: All authors have declared no conflicts of interest.