ATTR-ACT
Trial question
What is the role of tafamidis in patients with transthyretin amyloid cardiomyopathy?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
10.0% female
90.0% male
N = 441
441 patients (43 female, 398 male).
Inclusion criteria: patients with transthyretin amyloid cardiomyopathy.
Key exclusion criteria: Presence of primary (light chain) amyloidosis, prior liver or heart transplantation or implanted cardiac mechanical assist device, a NYHA (NYHA) classification of IV.
Interventions
N=264 tafamidis (received 80 mg of tafamidis or 20 mg of tafamidis once daily).
N=177 placebo (matching placebo once daily).
Primary outcome
All-cause death
29.5%
42.9%
42.9 %
32.2 %
21.4 %
10.7 %
0.0 %
Tafamidis
Placebo
Significant
decrease ▼
NNT = 7
Significant decrease in all-cause death (29.5% vs. 42.9%; HR 0.7, 95% CI 0.51 to 0.96).
Secondary outcomes
Significant decrease in cardiovascular-related hospitalizations (0.48 vs. 0.7; RR 0.68, 95% CI 0.56 to 0.81).
Conclusion
In patients with transthyretin amyloid cardiomyopathy, tafamidis was superior to placebo with respect to a all-cause death.
Reference
Maurer MS, Schwartz JH, Gundapaneni B et al. Tafamidis Treatment for Patients with Transthyretin Amyloid Cardiomyopathy. N Engl J Med. 2018 Sep 13;379(11):1007-1016.
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