Six Trials of Interest at ESC 2025:
Six Trials of Interest at ESC 2025:
1. DIGIT-HF (Digitoxin in HFrEF)
• Old digitalis drugs have long been criticized.
• The DIG trial showed no mortality benefit, but did reduce HF hospitalizations.
• DIGIT-HF tests digitoxin (safer pharmacology than digoxin) in HFrEF patients.
• Challenge: proving a 20% benefit on top of strong modern therapies is unlikely.
• So far, digoxin/digitoxin has only been shown to reduce HF hospitalizations, without improving survival — most often used in HFrEF patients, especially those with atrial fibrillation.
• If the trial shows no harm, digitoxin could regain interest as an option.
2. Beta-Blockers After MI (REBOOT-CNIC & BETAMI-DANBLOCK)
• Beta-blockers are still routinely used after MI, but this is based on old 1980s trials, before PCI and modern therapy.
• Recent smaller trials (REDUCE-AMI, ABYSS) showed no clear benefit in patients with preserved EF (>40%).
• REBOOT-CNIC (Spain, >8000 pts) and BETAMI-DANBLOCK (Norway/Denmark, >4000 pts) will provide definitive answers.
• Key point: If these confirm no benefit, routine beta-blocker use after MI with normal EF may end.
3. AQUATIC (OAC + Aspirin in Stable CAD/AF)
• Many AF patients on anticoagulation are also prescribed aspirin for CAD.
• The AFIRE trial (Japan) showed OAC alone was as effective and safer.
• AQUATIC tests OAC + aspirin vs OAC alone in stable CAD.
• Key point: Likely to confirm OAC alone is better and safer, reducing bleeding risk.
4. ALONE-AF (Stopping OAC After AF Ablation)
• Big daily question: can patients stop OAC after successful AF ablation?
• This trial tests stopping vs continuing OAC after 1 year without AF recurrence (with ≥1 stroke risk factor).
• Key point: If safe, many post-ablation patients may be able to discontinue OAC, reducing overtreatment.
5. REFINE-ICD (Better ICD Selection Post-MI)
• Most ICDs for primary prevention never deliver therapy → many patients get no benefit.
• REFINE-ICD uses two ECG markers (heart rate turbulence + T-wave alternans) in post-MI patients with EF 35–50% to guide ICD implantation.
• Key point: Could allow ICDs only for those at real risk.
Quick Notes” :
1. DIGIT-HF: Digitoxin may cut HF hospitalizations, but no survival benefit; mostly for HFrEF + AF.
2. Beta-blockers after MI: Likely no benefit if EF >40%; big trials may end routine use.
3. AQUATIC: OAC alone safer than OAC + aspirin in stable CAD/AF.
4. ALONE-AF: Trial may allow safe OAC discontinuation post-ablation.
5. REFINE-ICD: ECG markers may guide ICDs to those who truly need them.
ESC 2025 – Hot Line Presentation Schedule (Madrid)
• DIGIT-HF: Friday, 29 August at 11:30 (Press Conference 1).
• REBOOT-CNIC & BETAMI-DANBLOCK: Saturday, 30 August around 11:00 (Press Conferences 2 & 3).
• AQUATIC: Sunday, 31 August at 08:51 (Press Conference 6).
• ALONE-AF: Sunday, 31 August at 17:30 (Press Conference 7 or 8).
• REFINE-ICD: Will also be presented in a Hot Line session (exact time to be confirmed in the ESC schedule).