Heart failure & cardiomyopathies
Effect of Tafamidis on Cardiac Function in Patients With Transthyretin Amyloid Cardiomyopathy: A Post Hoc Analysis of the ATTR-ACT Randomized Clinical Trial
Authors' conclusion
Compared with placebo, tafamidis, 80 mg, attenuated the decline of LV systolic and diastolic function over 30 months in patients with ATTR-CM.
Study context
- Population
- Patients aged 18 to 90 years with ATTR-CM, 48 sites in 13 countries436 with echocardiographic data
- Participants
- 441 patients
- Comparison
- Tafamidis 80 mg vs placebo
- Tafamidis, 80 mgn = 176
- Placebon = 177reference
- Primary endpoint
- Changes from baseline in LVEF, left ventricular (LV) stroke volume, LV global longitudinal strain and septal and lateral E/e'
- Follow-up
- Month 30
Methodological detailsexploratory, post hoc, multicentre, international, double-blind, placebo-controlled, phase 3, Conducted December 2013 to February 2018; data analysed July 2018 to September 2023
- Exploratory
- Post hoc
- Multicentre
- International
- Double-blind
- Placebo-controlled
- Phase 3
- Conducted December 2013 to February 2018; data analysed July 2018 to September 2023
Primary result
As reported in the abstract
Change in echocardiographic measures · 30 months
Tafamidis, 80 mg vs PlaceboLeast squares mean difference, mL (95% CI)P value
LV stroke volume
7.02(2.55–11.49)
P = 0.002Tafamidis, 80 mg vs PlaceboLeast squares mean difference, % (95% CI)P value
LV global longitudinal strain
−1.02(−1.73 to −0.31)
P = 0.005Tafamidis, 80 mg vs PlaceboLeast squares mean difference (95% CI)P value
Septal E/e'
−3.11(−5.50 to −0.72)
P = 0.01Lateral E/e'
−2.35(−4.01 to −0.69)
P = 0.006Further findings
Baseline LVEF category · enrollment
- HF with preserved LVEF (≥50%)
- 220 (50.5%)
- HF with mildly reduced LVEF (41% to 49%)
- 119 (27.3%)
- HF with reduced LVEF (≤40%)
- 97 (22.2%)
Original publication
Effect of Tafamidis on Cardiac Function in Patients With Transthyretin Amyloid Cardiomyopathy: A Post Hoc Analysis of the ATTR-ACT Randomized Clinical Trial. JAMA Cardiol. Published 1 January 2024. doi:10. 1001/ jamacardio. 2023. 4147
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