Does catheter ablation for Afib reduce the risk of stroke compared to antiarrhythmics?
Study design: Open-label, multicenter, randomized trial
Population: 2,204 patients with symptomatic AF
- Inclusion criteria: Symptomatic AF patients, both paroxysmal and non-paroxysmal AF
- Exclusion criteria: Not provided
Interventions
- Experimental group: Catheter ablation (n=1,108)
- Control group: Drug therapy (n=1,096)
Primary outcome: Composite of death, disabling stroke, serious bleeding, or cardiac arrest
Secondary & Safety Outcomes
| Safety Outcomes | Catheter Ablation Group | Drug Therapy Group |
|---|---|---|
| Serious Bleeding | 3.2% | 3.3% |
| Disabling Stroke | 0.3% | 0.6% |
| Cardiac Arrest | 0.6% | 1.0% |
| All-cause Mortality | 5.2% | 6.1% |
| Total Mortality or Cardiovascular Hospitalization | HR 0.83 | 95% CI, 0.74-0.93; p = 0.001 |
| AF Recurrence | HR 0.52 | 95% CI, 0.45-0.60; p < 0.001 |
Potential Issues and Biases
Treatment crossovers: 102 (9.2%) patients randomized to ablation never received the ablation, and 301 (27.5%) patients randomized to the drug group crossed over to receive an ablation during their follow-up.
Use of a composite primary endpoint: Components of the composite endpoint had major disparity in clinical importance, which could pose a challenge in interpreting the results.
Intention-to-treat (ITT) analysis limitations: Non-compliance with the assigned treatment can undermine the effect of randomization and potentially bias the estimated effect. The authors used as-treated and per-protocol analyses to address these limitations.
Conclusion
The CABANA trial showed no significant difference in the primary outcome, but secondary outcomes favored catheter ablation. In patients with symptomatic AF, catheter ablation led to significant improvements in quality of life at 12 months without increasing the risk of complications compared with medical therapy.
Hess, P. L. (2019). Catheter ablation versus antiarrhythmic drug therapy for AF: CABANA trial. American College of Cardiology.