Evaluation of the efficacy and safety of direct oral anticoagulants in patients with atrial fibrillation in the perioperative and long-term periods after catheter ablation

Abstract

Objective. To conduct a comprehensive assessment of the efficacy and safety of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) at different stages of catheter ablation (CA).

Material and methods. In a single-center bidirectional study conducted between 2016 and 2024, two patient cohorts were formed: a retrospective cohort (n=1005) for the analysis of perioperative outcomes and a prospective cohort (n=597) for the evaluation of long-term results. In the retrospective sample, apixaban was prescribed to 382 patients, rivaroxaban to 492, and dabigatran to 131, whereas in the prospective cohort these numbers were 246, 279, and 51, respectively. The mean age of patients in the retrospective and prospective cohorts was comparable: 59.8±10.6 and 58.5±10.8 years, respectively. The median follow-up in the long-term period was 23.0 [11.0; 38.0] months. The primary composite endpoint included all-cause mortality, cardiac death, thromboembolic events (TEEs), left atrial appendage thrombosis, and ischemic events. Safety outcomes were assessed by the incidence of bleeding, classified according to the International Society on Thrombosis and Haemostasis (ISTH) criteria, as well as procedure- and access site-related complications.

Results. No major TEEs were observed in the perioperative period; bleeding events were extremely rare, with only one minor bleeding episode registered in the rivaroxaban group (0.2%), with no statistically significant differences between groups (p=0.99). In the early postoperative period, the incidence of bleeding was 1.0% with apixaban, 1.2% with rivaroxaban, and 3.1% with dabigatran; between-group differences did not reach statistical significance (p=0.093). However, post-puncture hematomas occurred significantly more often in patients receiving dabigatran (1.5%) compared with apixaban and rivaroxaban, where no such complications were observed (p=0.017). During long-term follow- up, two thromboembolic events were recorded: one ischemic stroke after DOAC discontinuation and one transient ischemic attack in a patient on dabigatran 150 mg/day with concomitant hematuria. The incidence of any bleeding was significantly higher with dabigatran compared to rivaroxaban and apixaban (5.9, 0.7, and 0%, respectively; p=0.003). Similarly, minor bleedings were significantly more frequent with dabigatran compared to rivaroxaban and apixaban (3.9%, 0.7%, and 0%, respectively; p=0.022). Major bleeding occurred only in the dabigatran group (2.0%), although the difference did not reach statistical significance (p=0.089).

Conclusion. The use of DOACs in patients with AF undergoing CA ensures effective prevention of TEEs with a low incidence of bleeding. Among the studied agents, apixaban demonstrated the most favorable safety profile throughout all follow-up stages, rivaroxaban provided comparable efficacy, whereas dabigatran was associated with a higher rate of hemorrhagic complications, particularly in the long-term period. These findings emphasize the importance of personalized anticoagulant therapy selection based on individual bleeding risk and patient clinical profile.