PAUSE-SCD
Trial question
Is first-line catheter ablation therapy superior to conventional medical therapy in patients with cardiomyopathy of varied etiologies?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
19.0% female
81.0% male
N = 121
121 patients (23 female, 98 male).
Inclusion criteria: patients with cardiomyopathy and monomorphic VT with an indication for ICD implantation.
Key exclusion criteria: acute STEMI within 60 days; revascularization within 45 days; reversible causes of VT or cardiomyopathy; LVEF < 15%; HF; life expectancy < 1 year.
Interventions
N=60 ablation therapy (early ablation therapy plus ICD implantation).
N=61 conventional therapy (medical therapy plus ICD implantation).
Primary outcome
Composite outcome of ventricular tachycardia recurrence, cardiovascular hospitalization or death
49.3%
65.5%
65.5 %
49.1 %
32.8 %
16.4 %
0.0 %
Ablation
therapy
Conventional
therapy
Significant
decrease ▼
NNT = 6
Significant decrease in composite outcome of VT recurrence, cardiovascular hospitalization or death (49.3% vs. 65.5%; HR 0.58, 95% CI 0.35 to 0.96).
Secondary outcomes
Significant decrease in VT recurrence (31.7% vs. 50.8%; HR 0.51, 95% CI 0.29 to 0.9).
No significant difference in cardiovascular hospitalization (28.3% vs. 32.8%; HR 0.82, 95% CI 0.43 to 1.56).
No significant difference in death from any cause (8.3% vs. 6.6%; HR 1.4, 95% CI 0.38 to 5.22).
Safety outcomes
Significant difference in ablation-related complications (8.3% vs. 0%).
Conclusion
In patients with cardiomyopathy and monomorphic VT with an indication for ICD implantation, ablation therapy was superior to conventional therapy with respect to the composite outcome of VT recurrence, cardiovascular hospitalization or death.
Reference
Roderick Tung, Yumei Xue, Minglong Chen et al. First-Line Catheter Ablation of Monomorphic Ventricular Tachycardia in Cardiomyopathy Concurrent with Defibrillator Implantation: The PAUSE-SCD Randomized Trial. Circulation. 2022 Jun 21;145(25):1839-1849.
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