Table 4.
Efficacy End Points by Malignancy Status in LDER and HDER Versus Warfarin
| End Point | Malignancy | No Malignancy | Interaction P Value | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Warfarin (N=395)a | LDER (N=368)a | LDER vs Warfarin HR (95% CI) | HDER (N=390)a | HDER vs Warfarin HR (95% CI) | Warfarin (N=6641)a | LDER (N=6666)a | LDER vs Warfarin HR (95% CI) | HDER (N=6645)a | HDER vs Warfarin HR (95% CI) | LDER vs Warfarin | HDER vs Warfarin | |
| Stroke/SEE | 24 (2.38) | 19 (2.04) | 0.87 (0.47–1.59) | 14 (1.43) | 0.60 (0.31–1.15) | 313 (1.77) | 364 (2.04) | 1.15 (0.99–1.34) | 282 (1.58) | 0.89 (0.76–1.05) | 0.38 | 0.25 |
| Ischemic stroke | 21 (2.08) | 16 (1.72) | 0.84 (0.43–1.62) | 12 (1.22) | 0.58 (0.29–1.18) | 214 (1.20) | 317 (1.77) | 1.47 (1.23–1.74) | 224 (1.25) | 1.04 (0.86–1.25) | 0.10 | 0.12 |
| MACE | 53 (5.33) | 40 (4.33) | 0.82 (0.54–1.24) | 35 (3.62) | 0.68 (0.44–1.04) | 873 (4.96) | 873 (4.93) | 0.99 (0.90–1.09) | 792 (4.45) | 0.90 (0.81–0.99) | 0.39 | 0.22 |
| MI | 16 (1.58) | 12 (1.28) | 0.83 (0.39–1.75) | 7 (0.72) | 0.46 (0.19–1.12) | 125 (0.70) | 157 (0.87) | 1.24 (0.98–1.57) | 126 (0.70) | 1.00 (0.78–1.28) | 0.29 | 0.09 |
| Cardiovascular death | 23 (2.20) | 18 (1.87) | 0.88 (0.48–1.64) | 16 (1.58) | 0.74 (0.39–1.40) | 588 (3.22) | 509 (2.76) | 0.85 (0.76–0.96) | 514 (2.80) | 0.87 (0.77–0.98) | 0.93 | 0.60 |
| All‐cause death | 120 (11.5) | 116 (12.1) | 1.07 (0.83–1.38) | 125 (12.4) | 1.09 (0.85–1.41) | 719 (3.94) | 621 (3.37) | 0.85 (0.76–0.95) | 648 (3.53) | 0.89 (0.80–0.99) | 0.08 | 0.15 |
All efficacy end points are analyzed in the intention‐to‐treat study population. CI indicates confidence interval; HDER, higher‐dose edoxaban regimen; HR, hazard ratio; LDER, lower‐dose edoxaban regimen; MACE, major adverse cardiovascular event (including myocardial infarction, stroke, or death attributable to cardiovascular cause or bleeding); MI, myocardial infarction; SEE, systemic embolic event.
a
Data are given as number (percentage/year).