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Amiodarone or Implantable Cardioverter-Defibrillator in Chagas Cardiomyopathy: The CHAGASICS Randomized Clinical Trial.
Martinelli-Filho, Martino; Marin-Neto, José A; Scanavacca, Mauricio Ibrahim; de Paola, Angelo Amato Vincenzo; Medeiros, Paulo de Tarso Jorge; Owen, Ruth; Pocock, Stuart J; de Siqueira, Sergio Freitas.
Afiliação
  • Martinelli-Filho M; Department of Cardiology, Instituto do Coração, Hospital das Clínicas da Universidade de São Paulo, São Paulo, Brazil.
  • Marin-Neto JA; Department of Interventional Cardiology, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, São Paulo, Brazil.
  • Scanavacca MI; Department of Cardiology, Instituto do Coração, Hospital das Clínicas da Universidade de São Paulo, São Paulo, Brazil.
  • de Paola AAV; Department of Cardiology, Escola Paulista de Medicina, São Paulo, Brazil.
  • Medeiros PTJ; Department of Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
  • Owen R; Oxon Epidemiology, Madrid, Spain.
  • Pocock SJ; Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.
  • de Siqueira SF; Department of Cardiology, Instituto do Coração, Hospital das Clínicas da Universidade de São Paulo, São Paulo, Brazil.
JAMA Cardiol ; 2024 Oct 02.
Article em En | MEDLINE | ID: mdl-39356542
ABSTRACT
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 11 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.

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: JAMA Cardiol Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Brasil País de publicação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: JAMA Cardiol Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Brasil País de publicação: Estados Unidos