CHAGASICS
Trial question
What is the role of ICD in patients with chronic Chagas cardiomyopathy at moderate-to-high risk of death?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 323
323 patients (138 female, 185 male).
Inclusion criteria: patients with chronic Chagas cardiomyopathy at moderate-to-high risk of death and at least 1 episode of nonsustained VT.
Key exclusion criteria: concomitant CVD; renal dysfunction; moderate-to-severe COPD; peripheral polyneuropathy; hypothyroidism or hyperthyroidism; current alcohol use disorder or quit alcohol use for < 2 years; mental disorder or illicit drug addiction.
Interventions
N=157 ICD (ICD implantation according to the institutional protocol of each participating center).
N=166 amiodarone (oral loading dose of 600 mg/day for 10 days, maintenance dose of 200-400 mg/day).
Primary outcome
All-cause mortality
38.2%
38.6%
38.6 %
29.0 %
19.3 %
9.7 %
0.0 %
Implantable
cardioverter-defibrillator
Amiodarone
No significant
difference ↔
No significant difference in all-cause mortality (38.2% vs. 38.6%; HR 0.86, 95% CI 0.6 to 1.22).
Secondary outcomes
Significant decrease in SCD (3.8% vs. 13.9%; HR 0.25, 95% CI 0.1 to 0.61).
Significant decrease in bradycardia requiring pacemaker (1.9% vs. 16.3%; HR 0.1, 95% CI 0.03 to 0.34).
Significant decrease in HF hospitalization (8.9% vs. 16.9%; HR 0.46, 95% CI 0.24 to 0.87).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with chronic Chagas cardiomyopathy at moderate-to-high risk of death and at least 1 episode of nonsustained VT, ICD was not superior to amiodarone with respect to all-cause mortality.
Reference
Martino Martinelli-Filho, José A Marin-Neto, Mauricio Ibrahim Scanavacca et al. Amiodarone or Implantable Cardioverter-Defibrillator in Chagas Cardiomyopathy: The CHAGASICS Randomized Clinical Trial. JAMA Cardiol. 2024 Dec 1;9(12):1073-1081.
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