Dronedarone as early rhythm control: post-hoc analysis of the ATHENA trial using EAST-AFNET4 criteria
Bibliographic record
Abstract
Abstract Introduction The EAST-AFNET4 study found that early, systematic rhythm control reduced cardiovascular (CV) outcomes in patients with early atrial fibrillation/atrial flutter (AF) of ≤12 months compared to guideline-recommended usual care. Purpose This post-hoc analysis aimed to assess whether antiarrhythmic drug therapy alone (i.e. dronedarone 400 mg BID) improved CV outcomes compared to placebo in patients with early AF in the ATHENA trial (NCT00174785; Ref 2) applying the EAST-AFNET4 criteria. Methods All patients in the randomised, placebo-controlled ATHENA trial with ≥2 CV conditions as defined in the EAST-AFNET 4 inclusion criteria and known AF duration at baseline were identified. Patients were split into early AF (≤12 months duration) and late AF (>12 months duration) subgroups. Outcomes were collected over a mean follow-up of 21 months and included a composite of CV death, stroke, or hospitalisation with worsening of heart failure or acute coronary syndrome; nights spent in hospital per year; and a safety composite endpoint comprising death, stroke, or pre-specified serious adverse events. All analyses were conducted in the intention-to-treat population. Results Dronedarone treatment was associated with significantly (p=0.014) fewer CV events vs placebo in patients with early AF (Fig 1). There was no interaction with AF duration (p=0.64). Patients on dronedarone spent numerically fewer nights in hospital vs placebo in early (13.4 vs 14.0) and late AF (13.9 vs 16.3), with no treatment interaction between subgroups (p=NS). Dronedarone was associated with more sinus rhythm (SR) at 12 months vs placebo (early AF: 79.9% vs 70.3%; late AF: 60.6% vs 54.0%), and similar rates of SR at 24 months (early AF: 65.8% vs 65.7%; late AF: 54.7% vs 54.1%). For the safety composite endpoint, estimated events/patients were as follows for the early AF group (dronedarone: 153/135; placebo: 182/165) and the late AF group (dronedarone: 86/81; placebo: 95/89). Conclusions The clinical benefit of early rhythm control found in the EAST-AFNET4 trial can be replicated in this analysis of patients with early AF treated in the ATHENA trial comparing dronedarone to placebo. These data support the use of dronedarone as part of early rhythm control. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Sanofi
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.013 | 0.011 |
| Meta-epidemiology (narrow) | 0.002 | 0.000 |
| Meta-epidemiology (broad) | 0.005 | 0.007 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".