Table 3.
Safety outcomes (presented as rates per 100 person years after application of overlap weighting) in patients undergoing rhythm or rate control
| Outcome | Early AF treatment (≤1 year since diagnosis) | Late AF treatment (>1 year since diagnosis) | |||||
|---|---|---|---|---|---|---|---|
| Rhythm control (n=9246) | Rate control (n=7077) | Absolute rate difference per 100 person years (95% CI) | Rhythm control (n=4407) | Rate control (n=1905) | Absolute rate difference per 100 person years (95% CI) | ||
| Composite safety outcome | 9.56 | 9.54 | 0.01 (−1.14 to 1.17)* | 11.13 | 9.83 | 1.30 (−0.72 to 3.32)† | |
| All cause death | 4.64 | 5.43 | −0.79 (−1.60 to 0.02) | 5.57 | 5.99 | −0.42 (−1.86 to 1.02) | |
| Intracranial bleeding | 0.86 | 0.90 | −0.04 (−0.38 to 0.29) | 0.61 | 1.06 | −0.45 (−1.00 to 0.10) | |
| Gastrointestinal bleeding | 1.78 | 2.30 | −0.52 (−1.04 to 0.00) | 2.45 | 2.78 | −0.33 (−1.32 to 0.66) | |
| Serious adverse event related to rhythm control: | |||||||
| Cardiac tamponade | 0.15 | 0.07 | 0.07 (−0.05 to 0.19) | 0.24 | 0.07 | 0.17 (−0.07 to 0.41) | |
| Syncope | 1.69 | 1.41 | 0.28 (−0.17 to 0.74) | 2.00 | 1.07 | 0.93 (0.17 to 1.68) | |
| Sick sinus syndrome | 1.29 | 0.47 | 0.82 (0.47 to 1.17) | 1.48 | 0.35 | 1.12 (0.54 to 1.71) | |
| Atrioventricular block | 0.50 | 0.24 | 0.25 (0.03 to 0.48) | 0.33 | 0.24 | 0.09 (−0.24 to 0.41) | |
| Pacemaker implantation | 0.54 | 0.29 | 0.25 (0.01 to 0.49) | 0.53 | 0.22 | 0.31 (−0.06 to 0.69) | |
| Sudden cardiac arrest | 0.69 | 0.61 | 0.08 (−0.21 to 0.37) | 0.56 | 0.72 | −0.15 (−0.63 to 0.33) | |
AF=atrial fibrillation.
*
The risk of composite safety outcome did not significantly differ according to treatment strategies with a weighted hazard ratio of 1.00 (95% confidence interval 0.88 to 1.23).
†
The risk of composite safety outcome did not significantly differ according to treatment strategies with a weighted hazard ratio of 1.13 (95% confidence interval 0.93 to 1.37).