Abstract 2950: The European Study of Epidemiology and Treatment of Cardiac Inflammatory Diseases (ESETCID) - Intermediate Analysis of Immunosuppressive Therapy
Treatment of inflammatory dilated Cardiomyopathy (iDCM) is still controversial. In ESETCID pts with autoreactive (virus-negative) myocarditis and an ejection fraction < 45% were randomised for 6 months of treatment with azathioprin (2mg/kg BW/day for 1 month and 0.85mg/kg BW/day for 5 months) + prednisolone (1.25mg/kg BW/for 1 month and 0.3mg/kg BW/day for 5 months) or placebo on top of their heart failure treatment.
Patients: 2452 pts were screened, 89 pts (mean age 47 ± 9 years, 70 male, 19 female) with iDCM could be randomized for ESETCID after informed consent.
Methods: Endomyocardial biopsies (EMB) were examined for lymphocytes & macrophages by immunhistochemistry according to the World Heart Federation (WHF)-criteria (≥ 14 infiltrating cells/mm2). Pts with viral or bacterial genomes for Parvo B19, coxsackie, influenza-, adeno-, cytomegalo-, herpes, EB virus, chlamydia and borreli the immunosuppression. 51 pts (41 m) were treated with verum, 37 pts ( 38m) with placebo.
Results: Inflammation was eradicated in 59% in the treatment group, but it also vanished spontaneously in 40% in the placebo arm. The difference was significant.(p < 0,05). NYHA-association class and Minnesota Heart Failure Score improved in treatment and placebo arm to a similar extend. Ejection fraction by echo and radionuclidventriculography improved in both arms. Independent from the immunosuppressive treatment patients with no inflammation in the follow-up biopsy (n = 45) showed a more improved NYHA-class by Class 2 + 0,73 when compared to those with persisting inflammation (n = 43) with NYHA 2,37 + 0,8 (p < 0,05). Similarily ejection fraction after 6 months was more reduced in persisting inflammation (EF = 38,3 + 14,15%) when compared to healed myocarditis (EF = 40,6 + 12,2%) (p < 0,05).
Conclusion: Immunosuppression is superior to conventional heart failure treatment in the eradication of the inflammatory infiltrate iDCM patients. Patients with no infiltrate at the end of treatment of the study had improved more than those, in whom inflammation had persisted.