A new randomised trial, CABANA, has failed to meet the primary endpoint while comparing catheter ablation to drug therapy in the treatment of patients suffering from new-onset or untreated arterial fibrillation (AF) that needed therapy.

The trial was sponsored by the National Institutes of Health (NIH) with support from St Jude Medical Foundation, Johnson and Johnson, Medtronic, Boston Scientific and Biosense Webster.

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It was conducted to assess the safety and efficacy of ablation, when compared with drug therapy, in a total of 2,204 patients in ten countries across North America, Europe, Asia and the Pacific.

The trial involved a follow-up period of five years.

“It was concluded that on an intention-to-treat analysis catheter ablation is not superior to drug therapy for cardiovascular outcomes at five years, but it showed better efficacy on as-treated analysis.”

During the single-blinded trial, ablation was performed using pulmonary vein isolation (PVI), wide area circumferential ablation (WACA) or ancillary ablation, while the drugs aimed to address heart rate or rhythm control.

The primary endpoint of death, disabling stroke, serious bleeding or cardiac arrest at five years was 8% with ablation, as opposed to 9.2% in the case of drug therapy.

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However, the ablation demonstrated favourable secondary outcomes, with a significant decrease in death or CV hospitalisation.

Based on these results, it was concluded that an intention-to-treat analysis catheter ablation is not superior to drug therapy for cardiovascular (CV) outcomes at five years, but it showed better efficacy on as-treated analysis.

The results from the study, which were reported by Mayo Clinic’s Dr Douglas Packer at the Heart Rhythm Society Scientific, are published by the American College of Cardiology Foundation.