Date: Tuesday, May 5, 2015
Session Time: 5:30pm-6:30pm
Presentation Time: 5:30pm-6:30pm
Location: Exhibit Hall E
Purpose. Development of cardiac allograft vasculopathy (CAV), renal dysfunction and malignancies are the main risks due to long-term immunosuppressive therapy after heart transplantation (HTx). We collected long-term follow-up data of a randomized HTx intervention cohort to compare the intended treatment containing tacrolimus (TAC) or cyclosporin A (CsA) both with mycophenolate mofetil (MMF).
Methods. After a mean duration of 15 years (enrollement 1998-2000) a prospective, randomized HTx cohort was analyzed as intention-to-treat. Randomized immunosuppressive regimens were TAC/MMF or CsA/MMF (n=60, randomization 1:1, corticosteroids were withdrawn after six month in patients without repeated rejection episodes, statines treatment routinely). Baseline characteristics were well balanced. CAV was graduated in accordance to the ISHLT classification.
Results: Study results are listed in the table
|TAC/MMF ITT (e)||CsA/MMF ITT (e)||p value|
|Duration after HTX (a)||15.1±0.7||14.9±0.9||0.544|
|Follow-up after HTX (a), (b)||10.9±5.1||11.7±5.1||0.589|
|Freedom from treatment switch||75.9%||53.3%||0.094|
|Freedom from acute rejection ≥2R (c)||65.5%||26.7%||0.004|
|Freedom from ISHLT CAV ≥1||38.5%||24.1%||0.042|
|Freedom from ISHLT CAV ≥2||84.6%||72.4%||0.361|
|Serum creatinine levels (mg/dL) (a),(d)||1.5±0.8||2.2±1.4||0.098|
Conclusions. This long-term analysis reveals, that a TAC-based treatment is superior over a CsA-based treatment regarding CAV onset and serum creatinine levels. Benefit of TAC/MMF over CsA/MMF regimen did not result in better long-term survival. Cross-over effects due to treatment switch and the small study cohort should be considered in this intention-to-treat analysis.
To cite this abstract in AMA style:Guethoff S, Grinninger C, Reichart B, Ueberfuhr P, Hagl C, Meiser B. Long-Term Results After Heart Transplantation A Randomized Trial Comparing Tacrolimus Versus Cyclosporine A in Combination With Mycophenolate Mofetil After a Mean Duration of 15 Years [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/long-term-results-after-heart-transplantation-a-randomized-trial-comparing-tacrolimus-versus-cyclosporine-a-in-combination-with-mycophenolate-mofetil-after-a-mean-duration-of-15-years/. Accessed January 19, 2021.
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