Cardiovascular-Related Mortality and Hospitalizations in Patients with Transthyretin Amyloid Cardiomyopathy Treated with Tafamidis: A Post Hoc Analysis of the Phase 3 ATTR-ACT and Long-Term Extension.

Authors

Thibaud Damy, Ronald Witteles, Francesco Cappelli, Ronnie Wang, Martha Grogan

Published in

Cardiology and therapy. Aug 27, 2026. Epub Aug 27, 2026.

Abstract

Patients with transthyretin amyloid cardiomyopathy (ATTR-CM) are at high risk of cardiovascular (CV)-related hospitalizations (CVH), which are associated with higher mortality. In the phase 3 study ATTR-ACT, treatment with tafamidis significantly reduced CVH versus placebo.
This post hoc analysis included patients from ATTR-ACT (30 months) and its long-term extension (LTE; 60 months) receiving tafamidis 80 mg (n = 176) or placebo in ATTR-ACT and switched to tafamidis 80 mg in the LTE (n = 177). CV-related events (CV-related mortality [CVM] and/or recurrent CVH) and CVM were evaluated. Liu-Wei-Yang-Ying and Cox proportional hazard models were used to evaluate time to recurrent CV-related events and CVM, respectively.
During ATTR-ACT, cumulative incidence of first and recurrent CV-related events in the tafamidis group was lower versus placebo from month 9 and incidence of CVM was lower from month 18. These trends continued throughout the LTE. At month 24, a significant 29% hazard reduction was observed for CV-related events with tafamidis 80 mg versus placebo (incidence 48% vs 61%; hazard ratio [HR] 0.713 [95% CI 0.524-0.970]; p = 0.0310). Hazard reduction remained significant until month 90 with continuous tafamidis 80 mg and was 37% at month 90 (incidence 77% vs 79%; HR 0.629 [95% CI 0.491-0.806; p = 0.0002]). Incidence of CVM with continuous tafamidis 80 mg was lower versus placebo(/tafamidis 80 mg) at month 24 (21% vs 29%) and month 90 (39% vs 47%), with significant hazard reductions of 38% (HR 0.618 [95% CI 0.401-0.954]; p = 0.0299) and 39% (HR 0.607 [95% CI 0.436-0.843]; p = 0.0029), respectively. Similar trends were observed in patients with baseline New York Heart Association (NYHA) functional class I/II but not with baseline NYHA class III.
Treatment with tafamidis significantly reduced the risk of CV-related events, including recurrent CVH and CVM, as early as month 24. This benefit continued for ≤ 90 months. Graphical abstract available for this article.
ClinicalTrial.gov identifiers: NCT01994889; NCT02791230.

PMID:
42658466
Bibliographic data and abstract were imported from PubMed on 28 Aug 2026.

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