Lower hospitalization risk seen with one ATTR-CM treatment in real-world study

Attruby (acoramidis) was associated with better heart-related outcomes and a lower risk of hospitalization than Vyndamax (tafamidis) among people with transthyretin amyloid cardiomyopathy (ATTR-CM), according to a new analysis of U.S. electronic health records.

The results were recently presented by David Lanfear, MD, the chief scientific officer and vice president of research at Henry Ford Health, at the Heart Failure Society of America Annual Scientific Meeting 2026 in Phoenix, Arizona. The findings are broadly consistent with an earlier, smaller analysis based on U.S. health insurance claims.

“In a prior real-world claims analysis, acoramidis was associated with fewer diuretic intensification events, suggesting the possibility of greater clinical stability on [Attruby], but this obviously needed to be interpreted with caution,” Lanfear said in a press release from Bridgebio, the company that sells Attruby in the U.S.

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What diuretic intensification means

Diuretic intensification generally means starting diuretic treatment or increasing it. These medications help remove excess fluid and reduce swelling caused by heart failure and other conditions.

“This new, larger, electronic health record study of nearly 2,700 individuals with ATTR-CM with longer follow-up and more granular data is better able to address the question, and shows a similar signal, with a significant difference in rates of cardiovascular or heart failure hospitalizations favoring [Attruby] compared to [Vyndamax], with approximately one quarter lower risk of events,” Lanfear said. Still, Lanfear said, “Additional investigations to replicate and extend these findings are warranted.”

ATTR-CM is a disorder in which transthyretin becomes unstable and forms abnormal clumps, called amyloid deposits, that build up in the heart and damage it. When the heart cannot pump blood effectively, excess fluid can build up in the body and cause swelling. Diuretics help remove this excess fluid.

Attruby and Vyndamax are both oral medications that work to stabilize the transthyretin protein, helping prevent it from breaking apart, misfolding, and forming amyloid deposits. Pfizer’s Vyndamax was approved for ATTR-CM in the U.S. in 2019 and was the only FDA-approved treatment for the condition until Attruby was approved in late 2024.

Clinical trials supporting the approvals of both therapies showed better ATTR-CM outcomes with treatment than with a placebo, but data directly comparing Attruby and Vyndamax remain limited.

Real-world records compare the two ATTR-CM treatments

Here, researchers compared outcomes between the two drugs using data from Epic COSMOS, the largest U.S. electronic health record database. After matching patients based on their characteristics, the analysis included 910 patients given Attruby and 1,774 given Vyndamax.

Results showed that Attruby-treated patients had a significantly lower risk — by 18% — of experiencing a combined outcome of death, hospitalization for any cause, new-onset atrial fibrillation, or diuretic intensification than those on Vyndamax.

“Early separation of the composite curves was noted within one month in this contemporary [group] of patients from 2025,” the release stated.

Attruby was also associated with a significantly lower risk of cardiovascular hospitalization by 27%, heart failure-related hospitalization by 27%, and hospitalization for any cause by 25%. Attruby-treated patients also had a significantly lower risk — by 17% — of diuretic intensification than those given Vyndamax.

Death and new-onset atrial fibrillation were also less common with Attruby, but the differences were not statistically significant, meaning they could have been due to chance.

The release attributed the lack of statistical significance to the small number of deaths and new cases of atrial fibrillation during the “limited duration of follow-up for these longer-term [outcomes].” Bridgebio said the outcomes will be reassessed as longer-term follow-up data become available.

Findings align with earlier real-world analysis

Although this real-world analysis has limitations, including the possibility that unaccounted-for factors influenced the results, the findings broadly align with earlier data that also favored Attruby over Vyndamax on heart-related outcomes.

“While electronic health record studies have well-recognized limitations, these data allow us to see how these therapies perform outside of a clinical trial, across a diverse and contemporary patient population,” Lanfear said. “Moreover, there appears to be some consistency of findings across data sources and [outcomes], supporting validity.”

Additional analyses of the placebo-controlled Phase 3 ATTRibute-CM clinical trial (NCT03860935), which supported Attruby’s approval, were also presented at the meeting.

One post hoc analysis of 611 ATTRibute-CM participants found that more cardiovascular-related hospitalizations were associated with a higher risk of death. Survival differed significantly across the hospitalization groups. At 30 months, 86.7% of participants with no cardiovascular hospitalizations were alive, compared with 47.7% of those with two or more.

Another post hoc analysis focused on outcomes among 35 ATTR-CM patients carrying p.Val142Ile, the most common genetic cause of the disease. In these participants, Attruby was better than placebo at preserving heart failure-related health status and quality of life, data showed.