EARNEST-PVI: Optimal AF ablation strategy remains unclear
PARIS — Both noninferiority and superiority could not be established when pulmonary vein isolation alone was compared with pulmonary vein isolation with additional ablation in patients with persistent atrial fibrillation, according to data from the EARNEST-PVI trial presented at the European Society of Cardiology Congress.
Koichi Inoue , MD, PhD, FESC, director of arrhythmic service and of the EP laboratory at Sakurabashi Watanabe Hospital in Osaka, Japan, and colleagues analyzed data from 497 patients who underwent an initial ablation procedure for persistent AF at eight experienced electrophysiology centers in Japan.
Patients were assigned pulmonary vein isolation alone (n = 249; mean age, 67 years; 75% men) or pulmonary vein isolation with an additional ablation (n = 248; mean age, 66 years; 77% men), which may be a linear ablation, complex fractionated atrial electrogram ablation or both.
The primary endpoints were recurrence of atrial tachycardia or AF with or without antiarrhythmic drugs during 1-year follow-up after a 3-month blanking period.
Pulmonary vein isolation was successful in both groups except for one patient in the pulmonary vein isolation alone group. Complex fractionated atrial electrogram ablation was performed in 15.3% of patients who underwent pulmonary vein isolation with an additional ablation compared with 85.1% for linear ablations.
“Linear ablation was the dominant strategy for substrate modification,” Inoue said during the presentation.
The recurrence-free ratio for patients assigned pulmonary vein isolation with an additional ablation was 78.3% compared with 71.3% for those assigned pulmonary vein isolation alone (HR = 1.56; 95% CI, 1.1-2.24; P for noninferiority = .3062).
“Because the upper limit of the confidence interval exceeded the noninferiority margin of 1.43 defined in this study, we could not demonstrate the noninferiority of the pulmonary vein isolation-alone strategy to the pulmonary vein isolation-plus strategy,” Inoue said during the presentation. “The lower limit of the confidence interval exceeded 1.0, which did not exceed the noninferiority margin of 1.43, we also could not demonstrate the superiority of the pulmonary vein isolation-plus strategy to the pulmonary vein isolation-alone strategy.”
The recurrence-free ratio without antiarrhythmic drugs after the 3-month blanking period was 65.7% for patients assigned pulmonary vein isolation alone and 73.9% for those assigned pulmonary vein isolation plus an additional ablation.
When assessed by ablation strategy, the recurrence-free ration for pulmonary vein isolation with linear ablation was 80% (95% CI, 74.5-85.8), 76% for pulmonary vein isolation with complex fractionated atrial electrogram ablation (95% CI, 62.7-92) and 70.7% for pulmonary vein isolation alone (95% CI, 65.2-76.6).
Five patients assigned pulmonary vein isolation alone experienced a procedure-related complication vs. nine patients in those assigned pulmonary vein isolation with additional ablation.
“Although our results were statistically inconclusive, they implied a better outcome for pulmonary vein isolation plus additional ablation than pulmonary vein isolation alone,” Inoue said during the presentation. “Further studies to clarify the optimal ablation strategies for persistent AF are required.” – by Darlene Dobkowski
Inoue K. Late Breaking Science in Atrial Fibrillation 1. Presented at: European Society of Cardiology Congress; Aug. 31-Sept. 4, 2019; Paris.
Disclosures: The EARNEST-PVI trial was funded by Abbott, Johnson & Johnson and Medtronic. Inoue reports he received personal fees from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Johnson & Johnson and Medtronic.