Abstract 1614: Sequential Analysis of Immunosuppressive Therapy in Autoreactive Myocarditis - Sequential Analysis from ESETCID

Abstract

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/mm 2 ), 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. Results

Immunosuppressive Therapy of Biopsy-Proven, Virus-Negative, Autoimmune/Immune-Mediated Myocarditis—Focus on Azathioprine: A Review of Existing Evidence and Future Perspectives

“…Another study by Maisch et al (the European Study on the Epidemiology and Treatment of Cardiac Inflammatory Disease), a double-blind, randomized, placebo-controlled trial IT with prednisolone and AZA was effective in patients with AI, virus-negative, inflammatory dilated cardiomyopathy with an LVEF <45% [ 50 ]. Following 6 months of treatment, a significant improvement was observed in both LVEF and major adverse cardiac events, which was still lasting after 1 year of follow-up.…”

“…Most available clinical studies seem to show an overall benefit from IT in the treatment of AI, biopsy-proven, virus-negative myocarditis, but the targeted therapy has still not been specified. Published studies have mostly presented inhomogeneous patient populations (small, underpowered groups) [ 53 ] at a different disease stage (acute vs. chronic myocarditis) [ 14 , 50 ], often with an undefined type of cellular infiltration (e.g., lymphocytic) and/or of unknown viral presence in heart biopsy [ 13 , 53 ].…”