REFINE-ICD Trial -Primary Prevention ICD After MI
REFINE-ICD Trial -Primary Prevention ICD After MI
Source: ESC 2025 Medical News | August 31, 2025
1. Background
• ICDs are used for primary prevention of sudden cardiac death in post-MI patients with reduced LVEF.
• The REFINE-ICD trial tested whether autonomic/electrical risk markers could identify patients who might benefit.
2. Study Design
• ~2000 screened; 597 enrolled (mean age 65; 20% female).
• Patients post-MI, LVEF 35–50%, with abnormal heart rate (HR) turbulence and exercise T-wave alternans (TWA):
• Abnormal HR turbulence = loss of the normal acceleration–deceleration pattern of heart rate after a premature beat, reflecting autonomic dysfunction.
• Abnormal TWA = beat-to-beat alternation in T-wave amplitude or shape on ECG, indicating electrical instability of the myocardium.
• Sites: US, Canada, Europe, Middle East, Africa.
• Follow-up: mean ~6 years.
3. Results
• Enrolled patients (with abnormal markers) had 2.6× higher risk of death vs those without abnormalities.
• Mortality at ~6 years: ICD 24.5% vs no-ICD 21.3% (HR 1.07; CI 0.77–1.50; p=0.69).
• Sudden death rates were very low: 2.6% (ICD) vs 3.8% (control).
• Non-cardiac deaths outnumbered cardiac deaths.
4. Key Observations
• Even in high-risk patients, modern therapy kept sudden death risk low.
• ICD offered no survival benefit in this group.
• Event rates were low enough to suggest results are reliable despite wide CIs.
5. Implications
• No role for primary prevention ICD in post-MI patients with LVEF 35–50% and abnormal HR turbulence/TWA.
• Modern revascularization and drugs (ARNI, SGLT2i, etc.) have transformed outcomes.
• Findings align with DANISH trial and declining sudden death rates globally.
• Supports PROFID-EHRA trial to retest ICD value in ischemic cardiomyopathy.
