7 Cardiology Headlines You Missed in September 2025

Cardiology has grown by leaps and bounds in September 2025, with several critical approvals from the US Food and Drug Administration (FDA) and a series of significant trial results presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2025.

The FDA’s approval of bumetanide nasal spray (Enbumyst) for edema associated with congestive heart failure (HF), liver disease, and chronic kidney disease (CKD) opened the door for a revolutionary new approach to HF treatment. Results from an analysis of the MAPLE-HCM trial reinforced the efficacy of aficamten in cardiomyopathy ahead of its December PDUFA date. And new research has highlighted a potential connection between marijuana use and various cardiovascular outcomes. In light of this slew of updates, the editorial team at HCPLive has collected some of the most important headlines from the past month: check them out below.

FDA Approvals

FDA Approves Bumetanide Nasal Spray for Edema with Congestive Heart Failure

Intranasal medication administration is a relatively unexplored avenue in cardiology. In addition to helping offset edema in patients with CHF, liver disease, and CKD, the approval of Bumetanide opens a pathway to avoiding blunted responses to loop diuretics and absorption blocks because of overreliance on intravenous administration. The medication achieved equivalence compared to its oral counterpart, with no significant difference in maximum plasma concentration between the 2 treatments.

FDA Approves Evinacumab (Evkeeza) for HoFH in Children As Young As 1 Year Old

On September 26, the FDA approved evinacumab as an adjunct to diet, exercise, and other lipid-lowering therapies for the treatment of children between the ages of 1 and 5 with homozygous familial hypercholesterolemia (HoFH). Initially approved for adults and adolescents ≥12 years old, this expanded indication meets a critical unmet need, given that HoFH causes dangerously high LDL-C levels from birth.

Trial Results

STEER: Wegovy Significantly Reduces Heart Attack, Stroke Risk in Patients with Obesity

Data presented at the European Society of Cardiology Congress by parent company Novo Nordisk, the STEER trial showcased the superiority of Wegovy (semaglutide) compared to tirzepatide in reducing heart attack, stroke, or all-cause mortality risk in patients with overweight or obesity. Wegovy saw a 57% greater risk reduction for all 3 conditions in patients with overweight and obesity with cardiovascular disease (CVD).

MAPLE-HCM: CPET Data Support Aficamten over Metoprolol as Monotherapy

A prespecified analysis of the MAPLE-HCM trial, presented at HFSA 2025, suggests the superiority of aficamten versus metoprolol in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). As aficamten’s December PDUFA date approaches, this new research highlights its effects on exercise capacity, showing significant improvements in both submaximal and maximal parameters versus metoprolol. Additionally, investigators saw improvements across ventilatory efficiency, pVO2, and other physiological markers.

Acoramidis Reduces Total Cardiovascular Events By Nearly 50% in ATTR-CM

In another presentation from HFSA 2025, an exploratory analysis of the ATTRibute-CM trial suggested acoramidis (Attruby) treatment over a 30-month period substantially reduced the risk of cumulative cardiovascular events by up to 49%. Compared to placebo, acoramidis resulted in 53 fewer cardiovascular events per 100 participants during the study period. Continuous use of acoramidis also saw a 45% reduction in cardiovascular mortality risk at 42 months versus patients transitioning from placebo to acoramidis.

Important Studies

Marijuana Use Increases Readmission, Mortality Risk in Heart Failure Hospitalizations

Because reported use of marijuana has risen to roughly 25% among the US population, its impact on patients hospitalized with heart failure has become a critical area of research. Now, data presented at HFSA 2025 has shown a potential connection between marijuana use and heart failure hospitalizations, with a 19% increased risk of readmission and a 60% increase in the odds of death during index admission versus patients without marijuana use. The trial also suggests that marijuana users may be more likely to have heart failure with reduced ejection fraction (HFrEF).

Don't Miss a Beat: Debating Oral Diuretic Intensification as an Endpoint in Heart Failure Trials

On this episode of DMAB, cohosts Stephen Greene, MD, and Muthiah Vaduganathan, MD, MPH, discuss the possibility of moving away from composite hospitalization and outpatient visit endpoints to changes in oral loop diuretic therapy. Given the treatment's frequency, prognostic value, and potential to increase event capture, oral diuretic changes could be a significant way of determining the success or failure of a medication in patients with HF.