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Functional Stability Measured by Changes in the 6-min Walk Test in Patients Treated with Tafamidis Versus Placebo:
Ronald Witteles1, Mazen A Hanna2, Martha Grogan3
1Stanford Amyloid Center, Division of Cardiovascular Medicine, Stanford University School of Medicine, 300 Pasteur Drive, Lane #154, Stanford, CA, USA. witteles@stanford.edu.
Introduction:
Tafamidis, a transthyretin stabilizer for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), significantly reduced the decline in 6-min walk test (6MWT) distance, a marker of functional stability, compared with placebo in the pivotal study ATTR-ACT. In this post hoc analysis, functional stability was assessed at month 12, and the subsequent impact of treatment on all-cause mortality (ACM) and cardiovascular-related hospitalization (CVH) was examined.
Methods:
Patients alive at month 12 who received tafamidis meglumine 80 mg (n = 149) or placebo (n = 149) were categorized by month 12 changes in 6MWT distance: stability (≤ 35-m decline from baseline) or progression (> 35-m decline from baseline). ACM and CVH rates during months 12-30 were evaluated using Cox proportional hazard and Poisson regression models, respectively.
Results:
A greater proportion of patients treated with tafamidis had 6MWT stability at month 12 (64%) vs. placebo (53%). Month 30 ACM incidence was 12% and 34% with 6MWT stability and progression, respectively, in the tafamidis group and 28% and 43%, respectively, in the placebo group. Among patients with 6MWT stability, tafamidis resulted in a 65% hazard reduction for ACM vs. placebo (hazard ratio 0.347 [95% CI 0.166-0.724]; p = 0.0048). Model-adjusted annual CVH rates with tafamidis were numerically lower vs. placebo (6MWT stability: 0.65 vs. 0.96; 6MWT progression: 1.19 vs. 1.59). A 32% reduction in CVH risk was observed with tafamidis vs. placebo (risk ratio 0.677 [0.500-0.916]; p = 0.0115) with 6MWT stability.
Conclusions:
Tafamidis resulted in a larger proportion of patients with functional stability after 12 months of treatment, with a significantly lower risk of ACM and CVH in patients with 6MWT stability during the subsequent 18 months. This post hoc analysis suggests treatment with tafamidis plays an important role in maintaining functional stability and improving outcomes for patients with ATTR-CM. Graphical abstract available for this article. TRIAL REGISTRATION: Clinicaltrials.gov ID NCT01994889.
