Efficacy and safety of dronedarone in patients with a prior ablation for atrial fibrillation/flutter : Insights from the ATHENA study
(2020) In Clinical Cardiology 43(3). p.291-297- Abstract
Background: The role of antiarrhythmic drugs for atrial fibrillation/atrial flutter (AF/AFL) after catheter ablation is not well established. Hypothesis: We hypothesized that changing the myocardial substrate by ablation may alter the responsiveness to dronedarone. Methods: We assessed the efficacy and safety of dronedarone in the treatment of paroxysmal/persistent atrial fibrillation/atrial flutter (AF/AFL) post-ablation, based on a post hoc analysis of the ATHENA study. A total of 196 patients (dronedarone 90, placebo 106) had an ablation for AF/AFL before study entry. In these patients, the effect of treatment on the first hospitalization because of cardiovascular (CV) events/all-cause death was assessed, as was AF/AFL recurrence in... (More)
Background: The role of antiarrhythmic drugs for atrial fibrillation/atrial flutter (AF/AFL) after catheter ablation is not well established. Hypothesis: We hypothesized that changing the myocardial substrate by ablation may alter the responsiveness to dronedarone. Methods: We assessed the efficacy and safety of dronedarone in the treatment of paroxysmal/persistent atrial fibrillation/atrial flutter (AF/AFL) post-ablation, based on a post hoc analysis of the ATHENA study. A total of 196 patients (dronedarone 90, placebo 106) had an ablation for AF/AFL before study entry. In these patients, the effect of treatment on the first hospitalization because of cardiovascular (CV) events/all-cause death was assessed, as was AF/AFL recurrence in individuals with sinus rhythm at baseline. The safety of dronedarone vs placebo was also determined. Results: In patients with prior ablation, dronedarone reduced the risk of AF/AFL recurrence (hazard ratio [HR]: 0.65 [95% confidence interval [CI]: 0.42, 1.00]; P <.05) as well as the median time to first AF/AFL recurrence (561 vs 180 days) compared with placebo. The HR for first CV hospitalization/all-cause death with dronedarone vs placebo was 0.98 (95% CI: 0.62, 1.53; P =.91). Rates of treatment-emergent adverse events were 83.1% vs 75.5% and rates of serious TEAEs were 27.0% vs 18.9% in the dronedarone and placebo groups, respectively. One death occurred with dronedarone (not treatment-emergent) and five occurred with placebo. Conclusion: In patients with prior ablation for AF/AFL, dronedarone reduced the risk of AF/AFL recurrence compared with placebo, but not the risk of first CV hospitalization/all-cause death. Safety outcomes were consistent with those of the overall ATHENA study.
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- author
- Vamos, Mate ; Calkins, Hugh ; Kowey, Peter R. ; Torp-Pedersen, Christian T. ; Corp dit Genti, Valérie ; Wieloch, Mattias LU ; Koren, Andrew and Hohnloser, Stefan H.
- organization
- publishing date
- 2020-03
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- ablation, antiarrhythmic drug, atrial fibrillation, atrial flutter, dronedarone
- in
- Clinical Cardiology
- volume
- 43
- issue
- 3
- pages
- 7 pages
- publisher
- Wiley-Blackwell
- external identifiers
-
- scopus:85077168159
- pmid:31872901
- ISSN
- 0160-9289
- DOI
- 10.1002/clc.23309
- language
- English
- LU publication?
- yes
- id
- 056d54bf-9fbd-4b72-9458-9c42d638a089
- date added to LUP
- 2020-01-17 12:33:44
- date last changed
- 2024-05-01 03:57:02
@article{056d54bf-9fbd-4b72-9458-9c42d638a089,
abstract = {{<p>Background: The role of antiarrhythmic drugs for atrial fibrillation/atrial flutter (AF/AFL) after catheter ablation is not well established. Hypothesis: We hypothesized that changing the myocardial substrate by ablation may alter the responsiveness to dronedarone. Methods: We assessed the efficacy and safety of dronedarone in the treatment of paroxysmal/persistent atrial fibrillation/atrial flutter (AF/AFL) post-ablation, based on a post hoc analysis of the ATHENA study. A total of 196 patients (dronedarone 90, placebo 106) had an ablation for AF/AFL before study entry. In these patients, the effect of treatment on the first hospitalization because of cardiovascular (CV) events/all-cause death was assessed, as was AF/AFL recurrence in individuals with sinus rhythm at baseline. The safety of dronedarone vs placebo was also determined. Results: In patients with prior ablation, dronedarone reduced the risk of AF/AFL recurrence (hazard ratio [HR]: 0.65 [95% confidence interval [CI]: 0.42, 1.00]; P <.05) as well as the median time to first AF/AFL recurrence (561 vs 180 days) compared with placebo. The HR for first CV hospitalization/all-cause death with dronedarone vs placebo was 0.98 (95% CI: 0.62, 1.53; P =.91). Rates of treatment-emergent adverse events were 83.1% vs 75.5% and rates of serious TEAEs were 27.0% vs 18.9% in the dronedarone and placebo groups, respectively. One death occurred with dronedarone (not treatment-emergent) and five occurred with placebo. Conclusion: In patients with prior ablation for AF/AFL, dronedarone reduced the risk of AF/AFL recurrence compared with placebo, but not the risk of first CV hospitalization/all-cause death. Safety outcomes were consistent with those of the overall ATHENA study.</p>}},
author = {{Vamos, Mate and Calkins, Hugh and Kowey, Peter R. and Torp-Pedersen, Christian T. and Corp dit Genti, Valérie and Wieloch, Mattias and Koren, Andrew and Hohnloser, Stefan H.}},
issn = {{0160-9289}},
keywords = {{ablation; antiarrhythmic drug; atrial fibrillation; atrial flutter; dronedarone}},
language = {{eng}},
number = {{3}},
pages = {{291--297}},
publisher = {{Wiley-Blackwell}},
series = {{Clinical Cardiology}},
title = {{Efficacy and safety of dronedarone in patients with a prior ablation for atrial fibrillation/flutter : Insights from the ATHENA study}},
url = {{http://dx.doi.org/10.1002/clc.23309}},
doi = {{10.1002/clc.23309}},
volume = {{43}},
year = {{2020}},
}