Table 1.
Steroid-free regimen in adult heart transplantation recipients.
| References | Study design | Participants and intervention | Survival | Rejection | Infections and other ADRs | Authors' conclusions | Quality assessment |
|---|---|---|---|---|---|---|---|
| 53 | Prospective RCT |
N = 60. SG: 29 pts, mean age 42 years, M:F = 23:6; SFG: 31 pts, mean age 40 years, M:F = 25:5 SG: Cyc + AZA + CSs SFG: Cyc + AZA |
SG: 2-year survival = 92%, SFG: 2-year survival = 93%. No patient died for transplant-related adverse events in both the groups | Higher overall incidence of rejection and at 1, 3, 6 and 12 months in the SFG (overall: 2.3 in SFG vs. 1.1 in SG, P < 0.002) | Overall incidence of infections: 1.6 in SG vs. 1.3 in SFG (P > 0.05). Similar occurrence of other ADRs, apart from obesity, being more common among SG pts (14/29 in SG vs. 9/31 in SFG) | The two protocols of therapy produce actuarial survival and morbidity rates comparable | 3/10 |
| 54 | Prospective RCT |
N = 112 SG: 59 pts; SFG: 53 pts. Reported as well matched at randomization. SG: Cyc + AZA + CSs SFG:Cyc + AZA |
Analyses were conducted “as treated”. SG survival rates: 86% and 78% at 2 years and 5 years, respectively; SFG survival rates: 85% and 82% at 2 years and 5 years, respectively(P > 0.05) | Analyses were conducted “as treated”. Higher incidence of rejection at 3 months in the SFG(2.3 episodes/100 patients vs. 1.5/100 patients in the SG, P = 0.01). No differences in rejection rates thereafter | Analyses were conducted “as treated”. Similar total infection rates but increased antihypertensive drug use and cholesterol levels in SG. Steroid-related morbidity and coronary artery disease were comparable between the two groups | The rate of steroid-related morbidity (diabetes, bone complications, cataracts, and obesity) was low in both the groups and did not differ significantly | 3/10 |
| 55 | Retrospective, observational | Only SFG. N = 112, M:F = 92:20, median age 50 (1–68 years). All patients: Cyc + AZA |
95% and 94% at 1 year and 2 years, respectively | Acute rejection was common (nearly 100%). Overall rejection rate: 1.7 ± 1.0 episodes per patient. Rejection-free survival rates: 20%, 10%, 7%, and 5% at 1, 6, 12, and 48 months. 21% of patients required steroid addition for persistent or repeated rejection | Infection rate was 0.1 ± 0.4 episode/patient. Freedom from infection survival rate was 85% at 2 years. Increasing trend in hypertension occurrence up to 57%. Lipid metabolism normal during follow-up | High incidence of acute rejection. Excellent medium-term survival and low incidence of both infection and chronic rejection | High quality |
| 56 | Prospective, open-label RCT |
N = 32, 1:1 randomization. SG: mean age 49 years, M:F = 14:18. SFG: mean age 51 years, M:F = 13:19. SG: TC + MMF + Prednisone. SFG: TC + MMF + TMG. All patients received intra-operative TMG |
One death per group (no further information) | Acute cellular rejections occurred in 69% of SG vs. 50% of SFG (P = 0.29). Mean number of acute cellular rejection episodes not significantly different between the two groups (1.07 in SG vs. 0.81 in SFG) | No difference in opportunistic infections incidence. Reduction in bone loss and augmented cardiac strength in the SFG. Four cases of skin cancers in the SFG group. No major bleedings, no lymphoproliferative disorders | With use of TMG, CSs avoidance seems to be safe with significant improvement in muscular strength and lower lost in bone density | 4/10 |
AZA, azathioprine; CSs, corticosteroids; Cyc, cyclosporine; OKT3, muromonab-CD3; SFG, steroid-free group; SG, steroid group; MMF, mycophenolate mofetil; TC, tacrolimus; TMG, thymoglobulin.