COMBINATION
Trial question
What is the role of LAA occlusion-first approach in patients with AF undergoing combined LAA occlusion and catheter ablation?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 194
194 patients (84 female, 110 male).
Inclusion criteria: adult patients with AF undergoing a combined LAA occlusion and catheter ablation procedure.
Key exclusion criteria: thrombus in the LAA or left atrium; left atrium diameter ≥ 55 mm; maximum ostium diameter of LAA > 30 mm; insufficient working depth for occlusion device implantation.
Interventions
N=97 occlusion-first approach (LAA occlusion with an implant before AF catheter ablation in a single procedure).
N=97 ablation-first approach (AF catheter ablation before LAA occlusion with an implant in a single procedure).
Primary outcome
Event-free survival rate for thromboembolic events, including stroke and transient ischemic attack, device-related thrombus, clinically relevant bleeding, and cardiovascular rehospitalization or death
83.5%
71.1%
83.5 %
62.6 %
41.8 %
20.9 %
0.0 %
Occlusion-first
approach
Ablation-first
approach
Significant
increase ▲
NNT = 8
Significant increase in event-free survival rate for thromboembolic events, including stroke and TIA, device-related thrombus, clinically relevant bleeding, and cardiovascular rehospitalization or death (83.5% vs. 71.1%; RR 1.17, 95% CI 0.05 to 2.29).
Secondary outcomes
Significant increase in long-term freedom from AF (77.3% vs. 63.5%; RR 1.22, 95% CI 0.05 to 2.39).
Significant increase in long-term freedom from atrial tachyarrhythmia (70.1% vs. 55.7%; RR 1.26, 95% CI 0.06 to 2.46).
No significant difference in AF-free survival at 1 year (85.6% vs. 81.4%; RR 1.05, 95% CI -1.51 to 3.61).
Safety outcomes
No significant difference in periprocedural complications.
Conclusion
In adult patients with AF undergoing a combined LAA occlusion and catheter ablation procedure, occlusion-first approach was superior to ablation-first approach with respect to a event-free survival rate for thromboembolic events, including stroke and TIA, device-related thrombus, clinically relevant bleeding, and cardiovascular rehospitalization or death.
Reference
Xianfeng Du, Huimin Chu, Bing Yang et al. Strategy Optimization for a Combined Procedure in Patients With Atrial Fibrillation: The COMBINATION Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2445084.
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