Arrhythmias & electrophysiologyRandomised controlled trial

Amiodarone or Implantable Cardioverter-Defibrillator in Chagas Cardiomyopathy

JAMA CardiolPublished

  • Randomised controlled trial
  • open-label
  • multicentre (13 centres in Brazil)
  • stopped prematurely for administrative reasons

Authors' conclusion

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.

Study context

Population
Chronic Chagas cardiomyopathy, Rassi score ≥10 (moderate to high risk) and ≥1 episode of nonsustained VTintended 1100
Participants
323 participants
Comparison
Implantable cardioverter-defibrillator (ICD) vs amiodarone
  • ICDn = 157
  • Amiodaronen = 166reference
Primary endpoint
All-cause mortality
Follow-up
Median 3.6 (IQR, 1.8-4.4) years

Primary result

As reported in the abstract

Hazard ratio

0.86

95% CI 0.60–1.22

P = 0.40

Events by treatment group

ICD vs Amiodarone
HR 0.86 (95% CI 0.60–1.22); P = 0.40

Secondary outcomes

OutcomeICDAmiodaroneHR (95% CI)P value
SCD3.8%13.9%0.25 (0.10–0.61)P = 0.001
Bradycardia requiring pacing1.9%16.3%0.10 (0.03–0.34)P < 0.001
HF hospitalization8.9%16.9%0.46 (0.24–0.87)P = 0.01

Original publication

Amiodarone or Implantable Cardioverter-Defibrillator in Chagas Cardiomyopathy. JAMA Cardiol. Published 1 December 2024. doi:10.1001/jamacardio.2024.3169

Summarised from the published abstract; every number is checked against it