Table 3.
Primary study endpoint [composite of all-cause death, stroke, and major bleeding (International Society on Thrombosis and Haemostasis)] in the per-protocol and the modified intent-to-treat population
| Edoxaban (ITT N = 411) | VKA (ITT N = 203) | HR (95% CI) | |
|---|---|---|---|
| PP population post-ablation a | |||
| N | 316 | 101 | |
| Primary endpoint events, n (%) | 1 (0.3) | 2 (2.0) | 0.16 (0.02–1.73) |
| PP population peri- and post-ablationb | |||
| N | 316 | 101 | |
| Primary endpoint events, n (%) | 4 (1.3) | 3 (3.0) | 0.42 (0.10–1.89) |
| mITT population peri- and post-ablation b | |||
| N | 375 | 178 | |
| Primary endpoint events, n (%) | 10 (2.7) | 3 (1.7) | 1.60 (0.44–5.78) |
a
From the end of catheter ablation to day 90/end of treatment.
b
From the start of catheter ablation to day 90/end of treatment.
CI, confidence interval; HR, hazard ratio; mITT, modified intent-to-treat; PP, per-protocol; VKA, vitamin K antagonist.