BERLIN-VT
Trial question
Is preventive ablation strategy superior to deferred ablation strategy in patients with ischemic cardiomyopathy and implantable defibrillator?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
13.0% female
87.0% male
N = 159
159 patients (20 female, 139 male).
Inclusion criteria: patients with stable ischemic cardiomyopathy, a LVEF between 30-50%, and VT.
Key exclusion criteria: age < 18 years or > 80 years; arterial or venous thrombosis; acute myocardial reinfarction; acute coronary syndrome; requirement of chronic renal dialysis.
Interventions
N=76 preventive ablation (prophylactic VT ablation prior to ICD implantation).
N=83 deferred ablation (catheter ablation after the third appropriate ICD shock).
Primary outcome
Composite of death and unplanned hospitalization for symptomatic ventricular arrhythmia or worsening heart failure
32.9%
27.7%
32.9 %
24.7 %
16.4 %
8.2 %
0.0 %
Preventive
ablation
Deferred
ablation
No significant
difference ↔
No significant difference in death and unplanned hospitalization for symptomatic ventricular arrhythmia or worsening HF (32.9% vs. 27.7%; HR 1.09, 95% CI 0.62 to 1.92).
Secondary outcomes
Borderline significant decrease in sustained ventricular tachyarrhythmia (39.7% vs. 48.2%; HR 0.62, 95% CI 0.38 to 1).
Significant decrease in appropriate ICD therapy (34.2% vs. 47%; HR 0.55, 95% CI 0.33 to 0.91).
Significant decrease in appropriate antitachycardia pacing (34.2% vs. 45.8%; HR 0.57, 95% CI 0.34 to 0.95).
Safety outcomes
No significant differences in death, unplanned hospitalization.
Conclusion
In patients with stable ischemic cardiomyopathy, a LVEF between 30-50%, and VT, preventive ablation was not superior to deferred ablation with respect to the composite of death and unplanned hospitalization for symptomatic ventricular arrhythmia or worsening HF.
Reference
Stephan Willems, Roland Richard Tilz, Daniel Steven et al. Preventive or Deferred Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy and Implantable Defibrillator (BERLIN VT): A Multicenter Randomized Trial. Circulation. 2020 Mar 31;141(13):1057-1067.
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