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Immunosuppressive therapy in virus-negative inflammatory cardiomyopathy: 20-year follow-up of the TIMIC trial
European Heart Journal ( IF 39.3 ) Pub Date : 2022-07-14 , DOI: 10.1093/eurheartj/ehac348
Cristina Chimenti 1, 2 , Matteo Antonio Russo 3 , Andrea Frustaci 1, 2
Affiliation  

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.

中文翻译:

病毒阴性炎症性心肌病的免疫抑制治疗:TIMIC 试验的 20 年随访

目的 对病毒阴性炎症性心肌病 (TIMIC) 试验方案中定制免疫抑制的长期结果进行了评估。方法和结果 85 名经心内膜活检证实为病毒阴性的慢性炎症性心肌病患者参加了随机、双盲、安慰剂对照的 TIMIC 试验,分别接受泼尼松和硫唑嘌呤 (n = 43) 与安慰剂 (n = 42) ) 6 个月。免疫抑制治疗促进了 88% 的病例的心功能改善,而安慰剂组中没有任何患者在 6 个月的研究期结束时转为 6 个月的免疫抑制治疗。将最初参加 TIMIC 试验(A 组)的 85 名患者的整个队列的长期(长达 20 年)临床结果与 1:2 倾向得分匹配的对照组患者未接受 TIMIC 方案治疗(B 组),且随访时间相当。主要结局是心血管死亡和心脏移植的复合结局。在长期随访中,心血管死亡风险 [风险比 (HR) 6.77;B 组患者的 95% 置信区间 (CI) 2.36–19.45] 和心脏移植 (HR 7.92;95% CI 1.80–34.88) 显着更高。与 B 组相比,A 组左心室射血分数持续改善(HR 7.24;95% CI 3.05–17.18)。较多数量的 B 组患者接受了植入式心律转复除颤器植入术。两组间复发性心肌炎的发生率相似,有复发性心脏炎症过程证据的患者对 TIMIC 协议应用程序迅速作出反应。结论 即使经过长期随访,病毒阴性炎症性心肌病仍可从免疫抑制治疗中获益。复发似乎响应新的 TIMIC 协议应用程序。
更新日期:2022-07-14
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