Importance Over 10 000 people with Chagas disease experience sudden cardiac death (SCD) annually, mostly caused by ventricular fibrillation. Amiodarone hydrochloride and the implantable cardioverter-defibrillator (ICD) have been empirically used to prevent SCD in patients with chronic Chagas cardiomyopathy. Objective To test the hypothesis that ICD is more effective than amiodarone therapy for primary prevention of all-cause mortality in patients with chronic Chagas cardiomyopathy and moderate to high mortality risk, assessed by the Rassi score. Design, Setting, and Participants CHAGASICS is an open-label, randomized clinical trial. The study enrolled patients from 13 centers in Brazil from May 30, 2014, to August 13, 2021, with the last follow-up November 8, 2021. Patients with serological findings positive for Chagas disease, a Rassi risk score of at least 10 points (intermediate to high risk), and at least 1 episode of nonsustained ventricular tachycardia were eligible to participate. Data were analyzed from May 3, 2022, to June 16, 2023. Interventions Patients were randomized 1:1 to receive ICD or amiodarone (with a loading dose of 600 mg after randomization). Main Outcomes and Measures The primary outcome was all-cause mortality, and secondary outcomes included SCD, hospitalization for heart failure, and necessity of a pacemaker during the entire follow-up. Results The study was stopped prematurely for administrative reasons, with 323 patients randomized (166 in the amiodarone group and 157 in the ICD group), rather than the intended 1100 patients. Analysis was by intention to treat at a median follow-up of 3.6 (IQR, 1.8-4.4) years. Mean (SD) age was 57.4 (9.8) years, 185 patients (57.3%) were male, and the mean (SD) left ventricular ejection fraction was 37.0% (11.6%). There were 60 deaths (38.2%) in the ICD arm and 64 (38.6%) in the amiodarone group (hazard ratio [HR], 0.86 [95% CI, 0.60-1.22]; P = .40). The rates of SCD (6 [3.8%] vs 23 [13.9%]; HR, 0.25 [95% CI, 0.10-0.61]; P = .001), bradycardia requiring pacing (3 [1.9%] vs 27 [16.3%]; HR, 0.10 [95% CI, 0.03-0.34]; P < .001), and heart failure hospitalization (14 [8.9%] vs 28 [16.9%]; HR, 0.46 [95% CI, 0.24-0.87]; P = .01) were lower in the ICD group compared with the amiodarone arm. Conclusions and Relevance In patients with chronic Chagas cardiomyopathy at moderate to high risk of mortality, ICD did not reduce the risk of all-cause mortality. However, ICD significantly reduced the risk of SCD, pacing need, and heart failure hospitalization compared with amiodarone therapy. Further studies are warranted to confirm the evidence generated by this trial. Trial Registration ClinicalTrials.gov Identifier: NCT01722942.

中文翻译：

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胺碘酮或植入式心脏复律除颤器治疗恰加斯心肌病：CHAGASICS 随机临床试验。


重要性 每年有超过 10 000 名恰加斯病患者经历心源性猝死 (SCD)，大部分由心室颤动引起。盐酸胺碘酮和植入式心律转复除颤器 (ICD) 已被经验性地用于预防慢性恰加斯心肌病患者的 SCD。目的 检验 ICD 比胺碘酮治疗更有效地一级预防慢性恰加斯心肌病和中度至高度死亡风险（通过 Rassi 评分评估）患者全因死亡的假设。设计、设置和参与者 CHAGASICS 是一项开放标签、随机临床试验。该研究招募了2014年5月30日至2021年8月13日期间来自巴西13个中心的患者，最后一次随访时间为2021年11月8日。血清学检查发现恰加斯病呈阳性的患者，Rassi风险评分至少为10分（中到高风险），并且至少有 1 次非持续性室性心动过速发作才有资格参加。数据分析时间为 2022 年 5 月 3 日至 2023 年 6 月 16 日。 干预措施 患者以 1:1 的比例随机分配接受 ICD 或胺碘酮（随机化后负荷剂量为 600 mg）。主要结局和措施 主要结局是全因死亡率，次要结局包括 SCD、心力衰竭住院以及整个随访期间起搏器的必要性。结果 由于管理原因，该研究提前停止，随机分配了 323 名患者（胺碘酮组 166 名，ICD 组 157 名），而不是原定的 1100 名患者。分析是按意向治疗进行的，中位随访时间为 3.6 年（IQR，1.8-4.4）。平均 (SD) 年龄为 57.4 (9.8) 岁，185 名患者 (57.3%) 为男性，平均 (SD) 左心室射血分数为 37.0% (11.0)。6%）。 ICD 组有 60 例死亡 (38.2%)，胺碘酮组有 64 例死亡 (38.6%)（风险比 [HR]，0.86 [95% CI，0.60-1.22]；P = .40）。 SCD 发生率（6 [3.8%] vs 23 [13.9%]；HR，0.25 [95% CI，0.10-0.61]；P = 0.001），需要起搏的心动过缓（3 [1.9%] vs 27 [16.3%] ]；HR，0.10 [95% CI，0.03-0.34]；P < .001），以及心力衰竭住院（14 [8.9%] vs 28 [16.9%]；HR，0.46 [95% CI，0.24-0.87] ]; P = .01) 与胺碘酮组相比，ICD 组较低。结论和相关性 对于中度至高死亡风险的慢性恰加斯心肌病患者，ICD 并未降低全因死亡风险。然而，与胺碘酮治疗相比，ICD 显着降低了 SCD、起搏需求和心力衰竭住院的风险。需要进一步的研究来证实该试验产生的证据。试验注册 ClinicalTrials.gov 标识符：NCT01722942。