Table 1: Primary and Secondary Outcomes in the EARLY-AF Study.
| Endpoint | Ablation Group (n=154) | Antiarrhythmic Group (n=149) | Treatment Effect (95% CI) |
|---|---|---|---|
| Recurrence of any atrial tachyarrhythmia | 66 (42.9) | 101 (67.8) | 0.48 (0.35–0.66)* |
| AF burden Median (IQR) Mean |
0 (0–0.08) 0.6 ± 3.3 |
0.13 (0–1.60) 3.9 ± 12.4 |
-3.3 ± 1.0† |
| Symptoms Documented recurrence of symptomatic arrhythmia Asymptomatic at 6 months Asymptomatic at 12 months |
17 (11.0) 129 (83.8) 131 (85.1) |
39 (26.2) 90 (60.4) 109 (73.2) |
0.39 (0.22–0.68)* 1.34 (1.17–1.55) 1.17 (1.05–1.30) |
| Quality of life Change from baseline EQ-5D score at 6 months Change from baseline EQ-5D score at 12 months Change from baseline AFEQT score at 6 months Change from baseline AFEQT score at 12 months |
0.08 ± 0.02 0.12 ± 0.02 24.4 ± 1.6 26.9 ± 1.9 |
0.07 ± 0.02 0.06 ± 0.02 17.9 ± 1.6 22.9 ± 2.0 |
0.03 ± 0.03‡ 0.07 ± 0.03‡ 10.5 ± 2.2‡ 8.0 ± 2.2‡ |
| Healthcare utilisation Cardioversion Emergency department visit Hospitalisation >24 hours |
30 (19.5) 10 28 5 |
36 (24.2) 14 30 13 |
0.81 (0.53–1.24)§ 0.69 (0.32–1.51)§ 0.90 (0.57–1.43)§ 0.37 (0.14–1.02)§ |
| Safety Any serious adverse event related to trial regimen Any safety endpoint |
5 (3.2) 14 (9.1) |
6 (4.0) 24 (16.1) |
0.81 (0.25–2.59)§ 0.59 (0.29–1.21)§ |
Data with ± values are mean ± SE, except for AF burden, which is mean ± SD. Data in the second and third columns are observed data, and data in column four are model-based effect estimates. *The treatment effect is expressed as the HR and 95% CI, which were calculated using Cox regression. †The between-group absolute difference in AF burden, expressed as the beta coefficient ±SE, was calculated using linear regression analysis. ‡Changes in quality of life scores at 6 months and 12 months from baseline are expressed as least-squares means ± SE and were analysed using a linear mixed-effects model for repeated measures, including group, visit, and interaction between group and visit. §The treatment effect is expressed as the RR and 95% CI. AFEQT = AF effect on quality of life; EQ-5D = European quality of life-5 dimensions; IQR = interquartile range.