TrialsgrambêtaRCTs are beautiful
ESC Congress 2026 · Hot Line 1Présenté ven. 28 août, 12:03 — dans le spécial congrès, en direct au fil des présentations.
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CMR GUIDE

Cardiac Magnetic Resonance GUIDEd Management of Mild-moderate Left Ventricular Systolic Dysfunction

Patient / Population Intervention / Exposition Comparaison Critère de jugement

In 353 patients with LVEF 36–50 % and scar on cardiac MRI, a primary-prevention ICD did not reduce sudden cardiac death or haemodynamically significant ventricular arrhythmia compared with an implantable loop recorder.

N
353patients
Schéma
Prospective, multicentre, open-label RCT, 1:1 (ICD vs implantable loop recorder), web-based randomisation stratified by site after core-lab LGE-CMR confirmation; recruitment mid-2015 to mid-2022, follow-up at least 3 years; Australia, UK and Europe
Critère
Time to composite of sudden cardiac death or haemodynamically significant ventricular arrhythmia (ventricular arrhythmia producing syncope or hypotension, SBP <90 mmHg)
Pertinence
2Important — l’un des piliers parmi d’autres.
Résultat7.8% vs 9.2% (HR 0.76, 95% CI 0.37-1.58); no significant difference. Sudden cardiac death alone 1.7% vs 5.8% (HR 0.26, 95% CI 0.07-0.95). Below 70 years a 72% relative reduction in the primary endpoint, none above.
Selvanayagam JB, et al. JAMA. 2026; published online 28 August. 10.1001/jama.2026.17078
Discussion et critique

Scar on CMR does not by itself earn a defibrillator at an ejection fraction of 36-50%: the primary endpoint is neutral and the interval spans a halving and a 58% increase. The isolated reduction in sudden cardiac death and the benefit below 70 years are the interesting part and the fragile part — few events, a secondary endpoint and a subgroup. The comparator was an implantable loop recorder, so the control arm was monitored rather than treated, and recruitment ran from 2015 to 2022 while medical therapy changed underneath the trial.

ESC Congress 2026 · Hot Line 1Présenté ven. 28 août, 12:03 — dans le spécial congrès, en direct au fil des présentations.
Tous les essais Hot Line →