Heart failure & cardiomyopathiesSecondary analysis
Effect of Acoramidis on Recurrent and Cumulative Cardiovascular Outcomes in ATTR-CM
- Post hoc exploratory recurrent-event analysis of the ATTRibute-CM randomised trial and its open-label extension
- phase 3
- modified Andersen-Gill model
Authors' conclusion
Acoramidis significantly reduced the cumulative burden of CV outcomes in ATTR-CM over 30 months.
Study context
- Population
- Patients with transthyretin amyloid cardiomyopathy (ATTR-CM)modified ITT population
- Participants
- 409 vs 202
- Comparison
- Acoramidis vs placebo
- Acoramidisn = 409
- Placebon = 202reference
- Primary endpoint
- Cumulative CV-related mortality or recurrent CV-related hospitalization
- Follow-up
- Month 30
Primary result
As reported in the abstract
CV-related mortality or recurrent CV-related hospitalization (cumulative risk) · through month 30
Acoramidis vs PlaceboHazard ratio (95% CI)P value
CV-related mortality or recurrent CV-related hospitalization (cumulative risk)
0.51(0.43–0.62)
P < 0.0001- month 30
- events avoided per 100 treated participants 53 (95% CI 29–79)
Further findings
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| CVM · month 42 | 0.55 (0.39–0.79) | P = 0.0011 | |
| 0.20.5125Hazard ratio (log scale) |
- CVM: continuous acoramidis vs placebo-to-acoramidis (open-label extension)
Annualized frequency of recurrent CVH · through month 30
- Significantly decreased; relative risk ratio 0.50 (95% CI 0.35-0.69)
- P < 0.0001
Cumulative cardiovascular (CV) outcome events avoided · month 30
- Events avoided per 100 treated participants
- 53 (95% CI 29-79)
- Numerically fewer cumulative events with acoramidis vs placebo from month 1, difference increasing progressively
CV outcome events within first 6 months
- Proportion of CVM or recurrent CVH events
- 19%
- Proportion of CVH events
- 22%
Original publication
Effect of Acoramidis on Recurrent and Cumulative Cardiovascular Outcomes in ATTR-CM. J Am Coll Cardiol. Published 28 September 2025. doi:10.1016/j.jacc.2025.09.013
Summarised from the published abstract; every number is checked against it