Heart failure & cardiomyopathiesSecondary analysis
Tafamidis Efficacy Among Octogenarian Patients in the Phase 3 ATTR-ACT and Ongoing Long-Term Extension Study
- Secondary analysis of the ATTR-ACT randomised trial and its long-term extension study
- post hoc analysis
- subgroup analysis by age
- open-label long-term extension
Authors' conclusion
The findings demonstrate tafamidis efficacy for patients with ATTR-CM both in those aged <80 and those aged ≥80 years.
Study context
- Population
- Patients with ATTR-CM aged <80 and ≥80 years in ATTR-ACT and its long-term extension (LTE) study
- Comparison
- Tafamidis vs placebo, by age <80 and ≥80 years
Primary result
As reported in the abstract
Change from baseline in 6MWT distance, NT-proBNP and KCCQ-OS (≥80 years) · 30 months in ATTR-ACT
Tafamidis (≥80 years)
51
n
Placebo (≥80 years)
37
n
- Smaller least squares (LS) mean change in 6MWT distance, NT-proBNP and Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) with tafamidis vs placebo, aged ≥80 years
- all P < 0.05
Further findings
Median, months
| Outcome | Tafamidis | Placebo | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Median survival, all-cause mortality (≥80 years, LTE) · all-cause mortality · interim analysis | 45 | 27 | 0.6828 (0.4048–1.1517) | P = 0.1526 | |
| Median survival (<80 years, LTE) | 80 | 41 | 0.4513 (0.3176–0.6413) | P < 0.0001 | |
| 0.20.5125Hazard ratio (log scale) |
- Median survival, all-cause mortality (≥80 years, LTE) — Smaller decline in KCCQ-OS score with continuous tafamidis
- P < 0.05
Median survival (<80 years, LTE)
- Smaller decline in KCCQ-OS score with continuous tafamidis
Original publication
Tafamidis Efficacy Among Octogenarian Patients in the Phase 3 ATTR-ACT and Ongoing Long-Term Extension Study. JACC Heart Fail. Published 8 November 2023. doi:10.1016/j.jchf.2023.08.032
Summarised from the published abstract; every number is checked against it