The European Society of Cardiology (ESC) Conference took place Aug 29 to Sep 1, 2025, and had multiple practice changing RCTs. This issue will showcase 3 important new publications.
Should patients with provoked VTE receive more than 3 months of apixaban?
Apixaban for Extended Treatment of Provoked Venous Thromboembolism (HI-PRO)
Piazza G et al. NEJM (August 2025)
Bottom Line: This randomized, double-blind, single-center trial evaluated whether extended low-dose apixaban therapy improves outcomes in patients who had a provoked (e.g., surgery, trauma, or immobility) venous thromboembolism (VTE) with ongoing risk factors following. After completing standard anticoagulation (at least 3 months), 600 participants were randomized to receive either low-dose apixaban (2.5 mg twice daily) or placebo for 12 months. The primary outcome was recurrent VTE. Results showed that patients receiving apixaban had a significantly lower incidence of recurrent VTE [(4 of the 300 patients (1.3%)] compared to those on placebo [(30 of the 300 patients (10.0%)] (hazard ratio, 0.13; 95% confidence interval [CI], 0.04 to 0.36; P<0.001). There was no increase in major bleeding or unexpected adverse effects.
Does the RSV vaccine prevent against hospitalization with RSV?
RSV Prefusion F Vaccine for Prevention of Hospitalization in Older Adults
Lassen MC et al. NEJM (August 2025)
Bottom line: This phase 4 randomized controlled trial evaluated the effectiveness of the RSV prefusion F–protein vaccine (RSVpreF) in adults aged 60 years and older during the 2024-2025 winter season in Denmark. 131,379 participants were randomized to receive either RSVpreF or no vaccine. The primary outcome was hospitalization for RSV-related respiratory tract disease. The vaccine group had fewer hospitalizations compared to the control group: 3 of 65,642 participants in the RSVpreF group and 18 of 65,634 participants in the control group (0.11 events vs. 0.66 events per 1000 participant-years; vaccine effectiveness, 83.3%; 95% confidence interval [CI], 42.9 to 96.9; P=0.007 for minimum effectiveness of >20%) The incidence of serious adverse events was similar in the two groups.
Is digitoxin (not to be confused with digoxin!) effective for patients with heart failure?
Digitoxin in Patients with Heart Failure and Reduced Ejection Fraction (DIGIT-HF)
Bavendiek U et al. NEJM (August 2025)
Bottom Line: This randomized, double-blind, placebo-controlled trial evaluated whether digitoxin improves outcomes in patients with chronic heart failure and reduced ejection fraction. Participants received either digitoxin (613 participants) or placebo (599 participants) in addition to guideline-directed medical therapy and were followed for a median of three years. The primary outcome was a composite of death from any cause or hospital admission for worsening heart failure. A primary-outcome event occurred in 242 patients (39.5%) in the digitoxin group and 264 (44.1%) in the placebo group (hazard ratio for death or first hospital admission for worsening heart failure, 0.82; 95% confidence interval [CI], 0.69 to 0.98; P=0.03). Safety analyses indicated a slightly higher rate of adverse events with digitoxin but without major unexpected concerns.
Trial Files Issue #2025-19