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

JAMA CardiolPublished Secondary analysis of the ATTR-ACT randomised 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 = 0.002
Tafamidis, 80 mg vs PlaceboLeast squares mean difference, % (95% CI)P value
LV global longitudinal strain
−1.02(−1.73 to −0.31)
P = 0.005
Tafamidis, 80 mg vs PlaceboLeast squares mean difference (95% CI)P value
Septal E/e'
−3.11(−5.50 to −0.72)
P = 0.01
Lateral E/e'
−2.35(−4.01 to −0.69)
P = 0.006

Further 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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