Key result
Cryoballoon ablation with minimally interrupted apixaban was comparable to radiofrequency ablation, with primary composite events occurring in 0.8% vs 2.4% of patients (RR 0.333; P=0.622).
Why the study?
The feasibility and safety of pulmonary vein isolation using cryoballoon ablation for paroxysmal atrial fibrillation with minimally interrupted apixaban had not been fully explored.
Does second-generation cryoballoon ablation reduce bleeding or thromboembolic events compared to radiofrequency ablation in patients with paroxysmal atrial fibrillation undergoing PVI with minimally interrupted apixaban?
RCT (n=250)
randomized
Yes
Does second-generation cryoballoon ablation reduce bleeding or thromboembolic events compared to radiofrequency ablation in patients with paroxysmal atrial fibrillation undergoing PVI with minimally interrupted apixaban?
Cryoballoon ablation with minimally interrupted apixaban is feasible and has a similar safety profile to radiofrequency ablation for paroxysmal atrial fibrillation, with a significantly shorter procedural duration.
Minimally interrupted apixaban appears feasible for CB-PVI in PAF; leaves open need for larger trials confirming safety versus uninterrupted regimens.
Background The feasibility and safety of pulmonary vein isolation (PVI) using cryoballoon (CB) for paroxysmal atrial fibrillation (PAF) with minimally interrupted apixaban has not fully explored. Methods In this multicenter, randomized prospective study, we enrolled patients with PAF undergoing CB or radiofrequency (RF) ablation with interrupted (holding 1 dose) apixaban. The primary composite end point consisted of bleeding events, including pericardial effusion and major bleeding requiring blood transfusion, or thromboembolic events at 4 weeks after ablation; secondary end points included early recurrence of AF and procedural duration. Results A total of 250 patients underwent PVI (125 assigned to the RF ablation and 125 assigned to the CB ablation). The primary end point occurred in 1 patient in the CB ablation group (0.8%; 90% confidence interval [CI], 0.04 to 3.70) and 3 patients in the RF group (2.4%, P = .622; risk ratio, 0333; 90% CI, 0.05 to 2.20). All events were pericardial effusion, all of whom recovered after pericardiocentesis. Early recurrence of AF occurred in 4 patients (3.2%) in the RF group and in 6 patients (4.8%) in the CB group (P = .749). The procedural duration was shorter in the CB group than that in the RF group (136.5 ± 39.9 vs 179.5 ± 44.8 min, P < .001). Conclusion CB ablation with minimally interrupted apixaban was feasible and safe in patients with PAF undergoing PVI, which was equivalent to RF ablation.
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Yagishita et al. (2020) conducted an RCT in paroxysmal atrial fibrillation (PAF) (n=250). Cryoballoon ablation vs. Radiofrequency ablation was evaluated on Composite of bleeding events (including pericardial effusion and major bleeding requiring blood transfusion) or thromboembolic events at 4 weeks after ablation (RR 0.333, 95% CI 0.05-2.20, p=0.622). Cryoballoon ablation with minimally interrupted apixaban was comparable to radiofrequency ablation, with primary composite events occurring in 0.8% vs 2.4% of patients (RR 0.333; P=0.622).
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