ATC Abstracts

American Transplant Congress abstracts

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: , , ,

Session Information

Date: Tuesday, May 5, 2015

Session Name: Poster Session D: "The Tell-Tale Heart": Allograft Rejection and Post-Transplant Monitoring

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 Randomized immunosuppressive regimens were TAC/MMF or CsA/MMF (n=60, randomization 1:1, corticosteroids were withdrawn after six month in patients without repeated rejection episodes, statines treatment routinely).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

Study results after a mean duration of 15 years after heart transplantation.
  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
(a) Mean±SD; (b) reduced due to death; (c) or 1R, if clinical treatment was required ; (d) in the subgroup of long-term survivors who were still alive by the end of 2014; (e) ITT, intention-to-treat.

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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