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
1Department of Cardiac Surgery, Ludwig-Maximilians University, Munich, Germany
2Transplantation Center, Ludwig-Maximilians University, Munich, Germany.
Meeting: 2015 American Transplant Congress
Abstract number: D255
Keywords: Graft arterlosclerosis, Heart transplant patients, Immunosuppression, Renal dysfunction
Session Information
Session Name: Poster Session D: "The Tell-Tale Heart": Allograft Rejection and Post-Transplant Monitoring
Session Type: Poster Session
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 Randomized immunosuppressive regimens were TAC/MMF or CsA/MMF (n=60, randomization 1:1, corticosteroids were withdrawn after six month in patients without repeated rejection episodes, statines treatment routinely).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 |
(95% CI) | (14.8-15.3) | (14.4-15.2) | |
Follow-up after HTX (a), (b) | 10.9±5.1 | 11.7±5.1 | 0.589 |
(95% CI) | (9.0-12.8) | (9.8-13.6) | |
Freedom from treatment switch | 75.9% | 53.3% | 0.094 |
(log-rank) | 2.8 | ||
Freedom from acute rejection ≥2R (c) | 65.5% | 26.7% | 0.004 |
(log-rank) | 8.5 | ||
Freedom from ISHLT CAV ≥1 | 38.5% | 24.1% | 0.042 |
(log-rank) | 4.1 | ||
Freedom from ISHLT CAV ≥2 | 84.6% | 72.4% | 0.361 |
(log-rank) | 0.8 | ||
Malignancies | 31.0% | 32.1% | 0.577 |
Serum creatinine levels (mg/dL) (a),(d) | 1.5±0.8 | 2.2±1.4 | 0.098 |
(95% CI) | (1.0-0.8) | (1.4-2.9) | |
Survival | 50.0% | 56.7% | 0.595 |
(log-rank) | 0.3 |
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 October 9, 2024.« Back to 2015 American Transplant Congress