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CABANA: after all, a positive trial.

CABANA is a multicentre randomized controlled trial comparing catheter ablation with optimal medical therapy in patients with all forms of atrial fibrillation (paroxysmal, persistent, and longstanding persistent). The initial primary endpoint of the study was total mortality, but that was changed during the study to a combined endpoint of total mortality, disabling stroke, major bleeding, and cardiac arrest. This change of the primary endpoint was due to slow enrolment into the trial, and it resulted in a reduction of the overall number of patients from almost 3000 to 2200 patients. The primary endpoint was analysed according to the intention-totreat principle, which means that patients in either group remained on the initial randomization, regardless of whether they had crossed over to the other group in the course of the trial. This type of analysis is the only way to guarantee that patients in both groups are comparable and rather compares treatment strategies, namely catheter ablation and medical therapy, in patients with atrial fibrillation. After 5 years of follow-up, there was no significant difference in the primary (combined) endpoint, with a hazard ratio of 0.86 (95% confidence interval, 0.65–1.15; P1⁄4 0.3). None of the components of the primary endpoint differed significantly. CABANA is therefore a negative trial. Does this change our clinical practice to ablate patients with atrial fibrillation? The answer is no. CABANA enrolled symptomatic patients with atrial fibrillation and showed that catheter ablation is an effective treatment for these patients. It did not show that there is an indication beyond symptomatic improvement, because none of the clinical outcome endpoints showed any benefit compared to medical treatment. Most guidelines recommend catheter ablation as a treatment option after the failure of medical treatment—except for young patients—if they are treated by very experienced ablationists. CABANA supports this indication in a large number of patients. CABANA also showed that catheter ablation is rather safe with a relatively low rate of severe complications. Only the 2.2% pericardial effusion rate gives rise to concern because it may result in cardiac tamponade and, potentially, death. It will be interesting to see whether the rate of pericardial effusion was lower in patients treated with balloon ablation as compared to point-by-point radiofrequency ablation. CABANA is an important trial. It confirms the efficacy of catheter ablation and supports current guidelines that catheter ablation should be performed in symptomatic patients with atrial fibrillation after at least one drug to treat atrial fibrillation has been tested.