ESC Congress 2025 – Late-breaking trial highlights

News

AFib, heart failure and TAVI 

Catch up on the first ESC 2025 late-breaking trial highlights! Discover key findings from the AMALFI trial on remote AFib screening, the DIGIT-HF trial assessing digitoxin in advanced HFrEF, and the DOUBLE-CHOICE trial comparing minimalist TAVI approaches and self-expanding valve performance.

Amina Rakisheva
Amina Rakisheva
Cardiologist
Kazakhstan

AMALFI Trial – Remote ECG Patch Screening for AFib

Design: Pragmatic RCT, 5,040 older patients (mean age: 78; 47 % female; 19 % prior stroke/TIA) randomised to 14-day mailed ECG patch vs. usual care, followed for 2.5 years.

Findings:

  • AFib diagnosis: 6.8 % (patch) vs. 5.4 % (control).
  • AFib burden: 33 % had continuous AFib; 55 % had < 10 % burden.
  • Anticoagulation exposure: 1.63 vs. 1.14 months.
  • Stroke: 2.7 % vs. 2.5 %.

Conclusion: Remote AFib screening modestly increased AFib detection and anticoagulation exposure, but without clear stroke reduction. 

Longer-term and cost-effectiveness analyses are needed.

Reference: JAMA, 2025. doi: 10.1001/jama.2025.15440

DIGIT-HF Trial – Digitoxin in Advanced HFrEF

Design: Multicenter RCT, 1,240 patients with chronic HFrEF (LVEF ≤ 40 % with NYHA III–IV or ≤ 30 % with NYHA II) randomised to digitoxin vs. placebo, in addition to guideline-directed therapy. Median follow-up: 36 months.

Findings:

  • Primary outcome (all-cause death or HF hospitalisation): 39.5 % (digitoxin) vs. 44.1 % (placebo).
  • All-cause mortality: 27.2 % vs. 29.5 %.
  • HF hospitalisation: 28.1 % vs. 30.4 %.
  • Serious adverse events: 4.7 % (digitoxin) vs. 2.8 % (placebo).

Conclusion: Digitoxin reduced the composite of death and HF hospitalisation in advanced HFrEF patients on optimal therapy. It may represent an additional therapeutic option, particularly in patients with AFib, tachycardia, low BP, or renal dysfunction.

Reference: NEJM, 2025. doi: 10.1056/NEJMoa2415471

DOUBLE-CHOICE Trial – Minimalist TAVI and Valve Comparison

Design: Multicenter RCT, 752 patients randomized to minimalist (local anesthesia only) vs. standard anesthesia; 855 patients randomized to ACURATE neo2 vs. Evolut valves. Patients had severe symptomatic AS suitable for both devices.

Findings (Anesthesia arm):

  • Primary endpoint at 30 days: 22.9 % (minimalist) vs. 25.8 % (standard).
  • Crossover: 19 % from minimalist to standard care.

Findings (Valve arm):

  • Primary endpoint: 15.4 % (ACURATE neo2) vs. 30.4 % (Evolut).
  • ACURATE neo2 reduced pacemaker implantation but has since been withdrawn.

Conclusion: Minimalist TAVI (local anesthesia) is safe in ~ 80 % of patients, with outcomes at least comparable to standard care. ACURATE neo2 valves showed favorable outcomes vs. Evolut, but are no longer available; design elements may inform future valve development.

Reference: Presented at ESC 2025.

Key Takeaways

  • AFib screening (AMALFI): Feasible, modest benefit, but uncertain impact on stroke.
  • Digitoxin (DIGIT-HF): Reduced mortality/HF hospitalisation in advanced HFrEF, potential niche role.
  • Minimalist TAVI (DOUBLE-CHOICE): Safe and effective for most; device-specific differences may guide next-generation valve design.