Chronic Use of Amiodarone Against Implantable Cardioverter-Defibrillator Therapy for Primary Prevention of Death in Patients With Chagas Cardiomyopathy Study - CHAGASICS

Oct 08, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Brazilian Ministry of Health
Date Published:
10/02/2024
Original Posted Date:
10/08/2024
References

Contribution To Literature:

The CHAGASICS trial failed to show that ICD implantation reduces all-cause mortality in chronic Chagas cardiomyopathy.

Description:

The goal of the trial was to evaluate implantable cardioverter-defibrillators (ICDs) compared with amiodarone among patients with chronic Chagas cardiomyopathy.

Study Design

  • Randomized
  • Parallel
  • Open-label

Patients with chronic Chagas cardiomyopathy were randomized to ICD (n = 157) vs. amiodarone (n = 166).

  • Total number of enrollees: 362
  • Total number randomized: 323
  • Duration of follow-up: median 3.6 years
  • Mean patient age: 57 years
  • Percentage female: 43%

Inclusion criteria:

  • Chronic Chagas cardiomyopathy
  • 18-75 years of age
  • Rassi risk score of ≥10 points
  • ≥1 episode of nonsustained ventricular tachycardia

Other salient features/characteristics:

  • Mean left ventricular ejection fraction: 37%

Principal Findings:

The trial was terminated early due to low enrollment. There were 362 subjects enrolled out of 1,100 initially intended.

The primary outcome, all-cause mortality, was 38.2% in the ICD group vs. 38.6% in the amiodarone group (p = 0.40).

Secondary outcomes:

  • Sudden cardiac death: 3.8% in the ICD group vs. 13.9% in the amiodarone group
  • Heart failure hospitalization: 8.9% in the ICD group vs. 16.9% in the amiodarone group

Interpretation:

Among patients with chronic Chagas cardiomyopathy, ICD implantation failed to reduce all-cause mortality compared with amiodarone. There was suggestion of benefit for ICD vs. amiodarone regarding the outcomes of sudden cardiac death and heart failure hospitalization. However, these were secondary outcomes, which need to be interpreted cautiously within a trial that prematurely stopped enrollment.

References:

Martinelli-Filho M, Marin-Neto JA, Scanavacca MI, et al. Amiodarone or Implantable Cardioverter-Defibrillator in Chagas Cardiomyopathy: The CHAGASICS Randomized Clinical Trial. JAMA Cardiol 2024;Oct 2:[Epublished].

Clinical Topics: Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Implantable Devices, SCD/Ventricular Arrhythmias

Keywords: Amiodarone, Chagas Cardiomyopathy, Defibrillators, Implantable


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