Immunosuppressive therapy in virus-negative inflammatory cardiomyopathy: 20-year follow-up of the TIMIC trial

被引:57
作者
Chimenti, Cristina [1 ,2 ]
Russo, Matteo Antonio [3 ]
Frustaci, Andrea [1 ,2 ]
机构
[1] Sapienza Univ Rome, Dept Clin Internal Anesthesiol & Cardiovasc Sci, Rome, Italy
[2] IRCCS L Spallanzani, Mol & Cellular Cardiol Lab, Rome, Italy
[3] San Raffaele 21 Univ, MEBIC Consortium, Rome, Italy
关键词
Inflammatory cardiomyopathy; Myocarditis; Immunosuppressive therapy; Follow-up; TIMIC; CARDIOLOGY WORKING GROUP; POSITION STATEMENT; EUROPEAN-SOCIETY; MYOCARDITIS; MANAGEMENT; DIAGNOSIS; BIOPSY;
D O I
10.1093/eurheartj/ehac348
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Aims Long-term results of the Tailored IMmunosuppression in virus-negative Inflammatory Cardiomyopathy (TIMIC) trial protocol have been evaluated. Methods and results Eighty-five patients with endomyocardial biopsy-proven virus-negative chronic inflammatory cardiomyopathy were enrolled in the randomized, double-blind, placebo-controlled TIMIC trial and received prednisone and azathioprine (n = 43) vs. placebo (n = 42) for 6 months. Immunosuppressive treatment promoted an improvement in cardiac function in 88% of the cases compared with none of the patients in the placebo group, which were switched to a 6-month immunosuppressive therapy at the end of the 6-month study period. Long-term (up to 20 years) clinical outcomes of the whole cohort of 85 patients originally enrolled in the TIMIC trial (Group A) were compared with those of a 1:2 propensity score-matched control cohort of patients untreated with the TIMIC protocol (Group B) and followed for a comparable period of time. The primary outcome was a composite of cardiovascular death and heart transplantation. At long-term follow-up, the risk of cardiovascular death [hazard ratio (HR) 6.77; 95% confidence interval (CI) 2.36-19.45] and heart transplantation (HR 7.92; 95% CI 1.80-34.88) was significantly higher in Group B patients. Group A showed a persistent improvement in the left ventricular ejection fraction compared with Group B (HR 7.24; 95% CI 3.05-17.18). A higher number of Group B patients underwent implantable cardioverter defibrillator implantation. The incidence of recurrent myocarditis was similar between groups, and patients with evidence of a recurrent cardiac inflammatory process promptly responded to a TIMIC protocol application. Conclusion Virus-negative inflammatory cardiomyopathy benefits from immunosuppressive therapy even after long-term follow-up. Recurrence appears to respond to a new TIMIC protocol application.
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收藏
页码:3463 / 3473
页数:11
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