Comparison of co-administration of amiodarone and rivaroxaban to co-administration of dronedarone and rivaroxaban for hemorrhage risks after atrial fibrillation ablation

Abstract

Purpose To investigate whether co-administration of antiarrhythmic dronedarone and anticoagulant rivaroxaban would increase the risks of hemorrhage after atrial fibrillation (AF) ablation. Methods A total of 100 patients with AF who underwent radiofrequency catheter ablation (CA) in the Department of Cardiology, the Affiliated Hospital of Qingdao University from 2019–12 to 2020–11 were included. Patients were divided into an oral dronedarone and rivaroxaban group (D-R group, N = 50) and an oral amiodarone and rivaroxaban group (A-R group, N = 50) according to the postoperative antiarrhythmic and anticoagulation strategies. Patients in 2 groups were given propensity score matching (PSM) to obtain a sample with balanced inter-group covariates. A retrospective observational study was conducted. After 3 months of follow-up, the incidence of clinically relevant non-major bleeding (CRNMB), major hemorrhages, and early AF recurrence was observed. Results After PSM, 41 patients were included in each group. With similarly distributed baseline characteristics and ablation characteristics after PSM, the CRNMB rate after AF ablation was significantly higher in the D-R group than in the A-R group (26.8% versus 7.3%, P = 0.02), and no major hemorrhages were detected in both groups. No significant difference was observed in the sinus rhythm maintenance rate between the D-R group and the A-R group (26.8% vs. 22.0%, P = 0.43). Conclusions Compared to co-administration of amiodarone and rivaroxaban, co-administration of dronedarone and rivaroxaban increases the risk of CRNMB but it does not increase the risk of major hemorrhages in blanking period after AF ablation.

Combination of Rivaroxaban and Amiodarone Increases Bleeding in Patients With Atrial Fibrillation

“…Based on other studies and the clinical practice in our center, we hypothesized that the incidence of bleeding was 12% and 25% in the rivaroxaban group and the combination group, respectively. [15][16][17] At least 136 patients in each group were required to achieve a power of 80% to detect a statistically significant difference with a 2-sided alpha level of .05. When estimating the sample size, we considered 2 factors that could result in sample loss: (1) propensity score matching (PSM), which we estimated would result in a 20% sample loss, and (2) a 3-month follow-up period, which we also estimated would result in a 20% sample loss.…”

“…However, CRNM and minor bleeding are also clinically important as they are more common complications, especially in the short-term follow-up period, because they often result in adverse consequences, including hospitalization and cessation of effective anticoagulation, which can lead to worse clinical outcomes. 17,30 Therefore, it is crucial to identify patients who require and would benefit from combination therapy, to ensure timely pharmaceutical care for those already receiving combination therapy, and to adjust medication regimens for patients who have experienced bleeding due to this pharmacokinetic interaction. For instance, patients who are at a higher risk of bleeding, such as older adults and those with impaired renal function, should be treated with caution when combining rivaroxaban and amiodarone.…”