Abstract 18491: BeTACTIC Study: Best Therapy After Cardiac Transplantation, the Italian Challenge
Introduction: Survival after heart transplantation (HTx) has improved, while the attrition rate beyond the 1st year did not change substantially. Cardiac allograft vasculopathy (CAV) and cancer are the leading causes of death late after HTx. Significant morbidity/mortality derive from renal insufficiency and vascular complications.
Hypothesis: Everolimus (Ev) and Micophenolate (MMF) were adopted due to better efficacy vs Azathioprine in de novo HTx. However, Ev and MMF have not been tested in a head to head comparison late after HTx. We assessed the effect of Ev and MMF on renal function late after HTx.
Methods: BeTACTIC is a multicenter, randomized, Investigator-driven trial, funded by the National Health Service, comparing efficacy and safety of Ev and MMF in association with Cyclosporine (CyA) in pts with acute multiple/late rejection (3 or more episodes requiring steroids), CAV, worsening renal dysfunction, enrolled at least 1yr after HTx and followed-up for 3 yrs. The primary endpoint was a composite of hierarchical occurrence of death, retransplantation, hospitalization for cardiovascular causes, reduction of EF, progression of CAV detected with coronary angiography/IVUS, renal function worsening and cancer.
Results and Conclusions: A total of 80 pts with a median age of 60 yrs, 84% men, were randomized in 9 Transplant Centers in Italy. Hypertension was present in 70% of pts, diabetes in 22.5%, CAD history CAD in 6.3%, and CHF in 7.6%. HTx was mainly due to dilated (47.4%) and ischemic (44.7%) cardiomyopathies. At 12 months, patients showing worsening of renal function accounted for the 32.5% of the cumulative incidence of the primary endpoint (53.8%). We evaluated the changes in the estimated glomerular filtration rate (eGFR) at 6 and 12 months from baseline. At 6 months the mean changes in eGFR did not differ between Ev and MMF (+1.25 vs 1.32, p=0.98); at 12 months there was a trend in favor of MMF, even if not statistically significant (+5.25 vs 0.92, p=0.18), stronger in patients assigned to MMF and enrolled in the trial after 5 years or more from HTx. We observed a significant reduction of CyA trough level in patients assigned to Ev. Results will be re-assessed at 3 years follow-up analysis.
Author Disclosures: F.M. Turazza: None. M. Franzosi: None. M. Frigerio: None. E. Gardinale: None. S. Barlera: None. M. Magnoli: None.
- © 2016 by American Heart Association, Inc.