Heart failure & cardiomyopathiesSecondary analysis
Effect of Aficamten on Health Status Outcomes in Obstructive Hypertrophic Cardiomyopathy
- Secondary analysis of the SEQUOIA-HCM randomised trial
- placebo-controlled
- phase 3
Authors' conclusion
In patients with symptomatic oHCM, treatment with aficamten resulted in markedly improved health status, including significant improvement in chest pain-related health status, than placebo.
Study context
- Population
- Symptomatic adults with obstructive hypertrophic cardiomyopathy (oHCM)
- Participants
- 282 adults
- Comparison
- Aficamten vs placebo
- Aficamtenn = 142
- Placebon = 140reference
- Primary endpoint
- Change in KCCQ-Overall Summary Score and SAQ7-Summary Score
- Follow-up
- 24 weeks
Primary result
As reported in the abstract
Change in KCCQ-OSS and SAQ7-SS
Aficamten
13.3 ± 16.3
KCCQ-Overall Summary Score (KCCQ-OSS) change · SAQ7-Summary Score (SAQ7-SS) change 11.6 ± 17.4
Placebo
6.1 ± 12.6
KCCQ-OSS change · SAQ7-SS change 3.8 ± 14.4
Aficamten vs PlaceboMean difference (95% CI)P value
KCCQ-OSS
7.9(4.8–11.0)
P < 0.001SAQ7-SS
7.8(4.7–11.0)
P < 0.001Further findings
Very large health status improvement (≥20 points)
KCCQ-OSS
SAQ7-SS
| Outcome | Aficamten | Placebo | P value |
|---|---|---|---|
| Change in health status after treatment withdrawal · 4-week washout | |||
| KCCQ-OSS change | −16.2 ± 19.0 | −3.0 ± 9.6 | P < 0.001 |
| SAQ7-SS change | −17.4 ± 21.4 | −2.5 ± 13.3 |
- Very large health status improvement (≥20 points) — NNT (KCCQ-OSS)
- 5.8
- Very large health status improvement (≥20 points) — NNT (SAQ7-SS)
- 5.8
Treatment effect across subgroups
- No heterogeneity in treatment effect across subgroups
Original publication
Effect of Aficamten on Health Status Outcomes in Obstructive Hypertrophic Cardiomyopathy. J Am Coll Cardiol. Published 1 September 2024. doi:10.1016/j.jacc.2024.08.014
Summarised from the published abstract; every number is checked against it