Abstract 1614: Sequential Analysis of Immunosuppressive Therapy in Autoreactive Myocarditis - Sequential Analysis from ESETCID
In the European Study on Epidemiology and Treatment of Cardiac Inflammatory Disease (ESETCID) pts with autoreactive (virus-negative) myocarditis (AM) and an ejection fraction <45% were randomised for 6 months of treatment with azathioprin (2mg/kg BW/day for 1 m and 0.85mg/kg BW/day for 5 m) + prednisolone (1.25mg/kg BW/ for 1 m and 0.3mg/kg BW/day for 5 m) or placebo on top of their heart failure treatment and followed-up for up to 8 years.
Patients: 3149 pts with dilated cardiomyopathy were screened, 103 pts (mean age 47± 9 years, 81 male, 22 female) with AM and an EF 14 infiltrating cells/mm2), persistence of viral or bacterial genomes for Parvo B19, coxsackie-, influenza-, adeno-, cytomegalo-, HHV 6, EBV, chlamydia and borrelia were excluded from the analysis. 56 pts (45 m) with AM were treated with verum, 47 pts ( 38m) with placebo. MACE are defined as cardiac death, heart transplantation, ICD implantation or hospitalisation for cardiac decompensation. Time to MACE is given in days to the event.
Results: Inflammation was eradicated in 63% in the treatment group, but it also vanished spontaneously in 40% in the placebo arm(p<0,05). After 12 months the Kaplan Mayer MACE curves began to diverge. At 4 years freedom from MACE was 50% in the verum and 40% in the placebo group. Respective data at 8 years were 40% and 20% freedom from MACE. NYHA-association class and Minnesota Heart Failure Score improved in treatment and placebo arms to a similar extend. Ejection fraction by echo and radioventriculography improved in both arms with a trend for immunosuppression(IS). Independent from IS pts with no inflammation in the follow-up biopsy (n=45) showed a better NYHA-class (p<0,05), ejection fraction and superior long term freedom from MACE than those with persistent inflammation..
Conclusion: Immunosuppression is superior to conventional heart failure treatment in the acute eradication of the inflammatory infiltrate iDCM patients and bears better long-term prognosis.