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. 2023 May 19;25(5):euad083.
doi: 10.1093/europace/euad083.

Cardiovascular outcomes in patients with atrial fibrillation concomitantly treated with antiarrhythmic drugs and non-vitamin k antagonist oral anticoagulants

Victor Chien-Chia Wu  1 , Chun-Li Wang  1 , Yu-Chang Huang  1 , Hui-Tzu Tu  2 , Yu-Tung Huang  2 , Chien-Hao Huang  3 , Shao-Wei Chen  4 , Chang-Fu Kuo  5   6 , Kuo-Chun Hung  1 , Shang-Hung Chang  1   2   7
Affiliations

Cardiovascular outcomes in patients with atrial fibrillation concomitantly treated with antiarrhythmic drugs and non-vitamin k antagonist oral anticoagulants

Victor Chien-Chia Wu et al. Europace. .

Abstract

Aims: Limited data compared antiarrhythmic drugs (AADs) with concomitant non-vitamin K antagonist oral anticoagulants in atrial fibrillation patients, hence the aim of the study.

Methods and results: National health insurance database were retrieved during 2012-17 for study. We excluded patients not taking AADs, bradycardia, heart block, heart failure admission, mitral stenosis, prosthetic valve, incomplete demographic data, and follow-up <3 months. Outcomes were compared in Protocol 1, dronedarone vs. non-dronedarone; Protocol 2, dronedarone vs. amiodarone; and Protocol 3, dronedarone vs. propafenone. Outcomes were acute myocardial infarction (AMI), ischaemic stroke/systemic embolism, intracranial haemorrhage (ICH), major bleeding, cardiovascular death, all-cause mortality, and major adverse cardiovascular event (MACE) (including AMI, ischaemic stroke, and cardiovascular death). In Protocol 1, 2298 dronedarone users and 6984 non-dronedarone users (amiodarone = 4844; propafenone = 1914; flecainide = 75; sotalol = 61) were analysed. Dronedarone was associated with lower ICH (HR = 0.61, 95% CI = 0.38-0.99, P = 0.0436), cardiovascular death (HR = 0.24, 95% CI = 0.16-0.37, P < 0.0001), all-cause mortality (HR = 0.33, 95% CI = 0.27-0.42, P < 0.0001), and MACE (HR = 0.56, 95% CI = 0.45-0.70, P < 0.0001). In Protocol 2, 2231 dronedarone users and 6693 amiodarone users were analysed. Dronedarone was associated with significantly lower ICH (HR = 0.53, 95%=CI 0.33-0.84, P = 0.0078), cardiovascular death (HR = 0.20, 95% CI = 0.13-0.31, P < 0.0001), all-cause mortality (HR 0.27, 95% CI 0.22-0.34, P < 0.0001), and MACE (HR = 0.53, 95% CI = 0.43-0.66, P < 0.0001), compared with amiodarone. In Protocol 3, 812 dronedarone users and 2436 propafenone users were analysed. There were no differences between two drugs for primary and secondary outcomes.

Conclusion: The use of dronedarone with NOACs was associated with cardiovascular benefits in an Asian population, compared with non-dronedarone AADs and amiodarone.

Keywords: Amiodarone; Atrial fibrillation; Dronedarone; Non-vitamin K antagonist oral anticoagulants; Propafenone.

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Conflict of interest statement

Conflict of interest: This investigator-sponsored study received funding from Sanofi. Victor Chien-Chia Wu, Chun-Li Wang, and Shang-Hung Chang received grants and support from Sanofi. The remaining authors have nothing to disclose.

Figures

Graphical Abstract
Graphical Abstract
Comparison of primary study outcomes of acute myocardial infarction, ischaemic stroke/systemic embolism, intracranial haemorrhage, major bleeding, cardiovascular death, and all-cause mortality in patients with atrial fibrillation using dronedarone vs. non-dronedarone antiarrhythmic drugs.
Figure 1
Figure 1
Study design and flow chart for the enrollment of patients with AF using dronedarone vs. non-dronedarone antiarrhythmic drugs.
Figure 2
Figure 2
Comparison of secondary study outcome of major adverse cardiovascular event (MACE), which was a composite of acute myocardial infarction, ischaemic stroke, and cardiovascular death in patients with AF using dronedarone vs. non-dronedarone antiarrhythmic drugs.
Figure 3
Figure 3
Study design and flow chart for the enrollment of patients with AF using dronedarone vs. amiodarone.
Figure 4
Figure 4
Comparison of primary study outcomes of acute myocardial infarction, ischaemic stroke/systemic embolism, intracranial haemorrhage, major bleeding, cardiovascular death, and all-cause mortality in patients with AF using dronedarone vs. amiodarone.
Figure 5
Figure 5
Comparison of secondary study outcome of major adverse cardiovascular event (MACE), which was a composite of acute myocardial infarction, ischaemic stroke, and cardiovascular death in patients with atrial fibrillation using dronedarone vs. amiodarone.
Figure 6
Figure 6
Study design and flow chart for the enrollment of patients with AF using dronedarone vs. propafenone.
Figure 7
Figure 7
Comparison of primary study outcomes of acute myocardial infarction, ischaemic stroke/systemic embolism, intracranial haemorrhage, major bleeding, cardiovascular death, and all-cause mortality in patients with AF using dronedarone vs. propafenone.
Figure 8
Figure 8
Comparison of secondary study outcome of major adverse cardiovascular event (MACE), which was a composite of acute myocardial infarction, ischaemic stroke, and cardiovascular death in patients with atrial fibrillation ( using dronedarone vs. propafenone.
See this image and copyright information in PMC

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