6082A prospective, multicenter, nationwide, observational study of flecainide controlled release on the quality of life of patients with atrial fibrillation in Greece, the REFLEC-CR study
Bibliographic record
Abstract
Abstract Background/Introduction Atrial fibrillation (AF) is the most common cardiac arrhythmia with a considerable impact on patients' quality of life (QoL). Flecainide acetate, is a class Ic antiarrhythmic agent, recommended as first line treatment in AF patients without underlying structural heart disease. Purpose This prospective, multicenter, nationwide, observational study aimed to evaluate the effect of oral treatment with controlled-release (CR) flecainide administered once daily on AF patients' QoL and treatment compliance during a 12-week period. Methods A total of 70 cardiologists participated in the study enrolling consecutive adult patients with paroxysmal or persistent AF, treated with flecainide CR in the context of a rhythm control strategy. The effect on QoL was assessed by the Canadian Cardiovascular Society Severity of Atrial Fibrillation scale (CCS-SAF) measured at baseline and at 12 weeks of treatment. Results In total, 679 patients (53.2% females, mean age 65.9±11.7 years, 86.9% paroxysmal AF) were included in the analysis. At least one prior antiarrhythmic treatment was documented in 43.8% of patients. The initial daily dose of flecainide CR was 100mg in 71.7% of the patients, with a titration to 200mg by the end of study achieved in 67%. In 93.6% of patients an excellent compliance score (100%) to treatment was recorded at the end of the study period. Treatment with flecainide CR resulted in a significant improvement in QoL as presented in the table. Table 1 CCS-SAF score Baseline (Week 0) End of study visit (Week 12) N=679 N=634 Class 1 (minimal effect on QoL) 343 (50.5) 464 (73.2) Class 2 (minor effect on QoL) 253 (37.2) 140 (22.1) Class 3 (moderate effect on QoL) 73 (10.8) 28 (4.4) Class 4 (severely impairs QoL) 10 (1.5) 2 (0.3) CCS-SAF continuous score Mean ± SD 1.64±0.73 1.32±0.57 Change from baseline‡ Mean (95% CI) −0.325 (−0.379, −0.271) p-value <0.0001 ‡Paired t-test is used. Conclusions This prospective, multicenter, observational study demonstrated that treatment of AF patients with flecainide CR, was associated with a significant improvement of QoL and excellent compliance to treatment. Acknowledgement/Funding Sponsored by WinMedica S.A.
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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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".