Global Efficacy of Aficamten in Nonobstructive Hypertrophic Cardiomyopathy: Results From ACACIA-HCM.
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Maron Martin S, Masri Ahmad, Bhatia Ankit, Peña-Peña Maria Luisa, Sherrid Mark V, Figueiredo Estevao Lanna, Arad Michael, Choudhury Lubna, Claggett Brian L, Coats Caroline J, de Barros Correia Edileide, Costabel Juan Pablo, Elliott Perry M, Silva Enciso Jorge E, Ge Junbo, Ho Carolyn Y, Kulac Ian, Lewis Gregory D, Martinez Matthew W, Maurer Mathew S, Michels Michelle, Mitter Sumeet S, Pino Moreno Jesus E, Olivotto Iacopo, Owens Anjali T, Poulsen Steen H, Rader Florian, Rowin Ethan J, Schulze P Christian, Sepp Robert, Sikand Nikhil, Solomon Scott D, Spertus John A, Zhao Xiaoyan, Divanji Punag H, Heitner Stephen B, Jacoby Daniel L, Kupfer Stuart, Malik Fady I, Salazar-Mendiguchía Joel, Wohltman Amy, Zhuo Shu, Barriales-Villa Roberto, ACACIA-HCM Investigators
Аннотация
METHODS: Patients with symptomatic nHCM were randomized to daily aficamten (n=258) or placebo (n=259) assessed at week 36, including (1) symptom burden (≥1 improvement in New York Heart Association class or reported improvement in Patient Global Impression of Change); (2) exercise capacity (≥0.5 mL/kg per min in peak oxygen uptake); (3) >10% decrease in left atrial volume index; (4) >10% improvement in septal early diastolic mitral annular velocity (e'); (5) ≥50% reduction in NT-proBNP (N-terminal pro-B-type natriuretic peptide). Overall clinical response was classified by the number of favorable outcomes achieved: nonresponder (none), limited (1 or 2), partial (3 or 4), or complete (all 5).
RESULTS: At 36 weeks, a greater proportion of patients treated with aficamten versus placebo experienced improvements in symptom burden (71% versus 53%), peak exercise capacity (45% versus 37%), left atrial volume index (31% versus 23%), septal e' (51% versus 26%), and NT-proBNP (63% versus 5%) (P<0.05 for all except peak oxygen uptake, P=0.1). Number needed to treat for aficamten ranged from 1.7 (NT-proBNP reduction) to 14 (peak oxygen uptake improvement) relative to placebo. A partial or complete clinical response (≥3 outcomes) was achieved in 53% of patients on aficamten versus 14% on placebo (P<0.001).
CONCLUSIONS: In patients with nHCM, aficamten was associated with improvements across a broad range of clinically relevant measures including symptom burden and diastolic function. These results underscore a potential benefit of aficamten in the population of patients with nHCM.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT06081894.