Table 2.
Outcome | Number of Events | IR, per 100 PYs | HR (95% CI) | P Value | P-inter | ||
---|---|---|---|---|---|---|---|
Direct Oral Anticoagulants | Warfarin | Direct Oral Anticoagulants | Warfarin | ||||
All bleeding (all/major/minor) | |||||||
Analyses 1 | |||||||
Overall | 574/76/498 | 607/126/481 | 20.0/2.7/17.3 | 17.9/3.7/14.2 | 1.08 (0.97 to 1.22) | 0.16 | |
eGFR≥60 | 350/39/311 | 390/76/314 | 17.3/1.9/15.4 | 16.8/3.3/13.5 | 1.01 (0.88 to 1.17) | 0.88 | 0.10 |
eGFR<60 | 224/37/187 | 217/50/167 | 26.3/4.4/21.9 | 20.1/4.6/15.5 | 1.23 (1.02 to 1.48) | 0.03 | |
Analyses 2 | |||||||
Overall | 863/111/752 | 805/155/650 | 14.9/1.9/13.0 | 13.8/2.7/11.1 | 1.09 (0.99 to 1.20) | 0.08 | |
eGFR≥60 | 537/63/474 | 520/93/427 | 12.9/1.5/11.4 | 12.7/2.3/10.4 | 1.03 (0.91 to 1.16) | 0.65 | 0.11 |
eGFR<60 | 326/48/278 | 285/62/223 | 20.0/2.9/17.1 | 16.3/3.6/12.7 | 1.21 (1.03 to 1.42) | 0.02 | |
Analyses 3 | |||||||
Overall | 574/76/498 | 740/142/740 | 16.8/2.2/14.6 | 15.1/2.9/12.2 | 1.18 (1.05 to 1.31) | 0.004 | |
eGFR≥60 | 350/39/311 | 475/87/388 | 14.7/1.6/13.0 | 14.1/2.6/11.5 | 1.11 (0.96 to 1.27) | 0.15 | 0.10 |
eGFR<60 | 224/37/187 | 265/55/210 | 21.8/3.6/18.2 | 17.2/3.6/13.6 | 1.33 (1.11 to 1.58) | 0.002 | |
Ischemic stroke | |||||||
Analyses 1 | |||||||
Overall | 222 | 244 | 6.9 | 6.6 | 0.97 (0.81 to 1.16) | 0.72 | |
eGFR≥60 | 136 | 152 | 6.0 | 6.0 | 0.94 (0.74 to 1.18) | 0.59 | 0.70 |
eGFR<60 | 86 | 92 | 8.8 | 7.8 | 1.02 (0.76 to 1.37) | 0.91 | |
Analyses 2 | |||||||
Overall | 305 | 301 | 4.4 | 4.5 | 1.00 (0.83 to 1.17) | 0.99 | |
eGFR≥60 | 191 | 193 | 4.0 | 4.2 | 0.97 (0.79 to 1.18) | 0.73 | 0.57 |
eGFR<60 | 114 | 108 | 5.6 | 5.3 | 1.06 (0.82 to 1.38) | 0.64 | |
Analyses 3 | |||||||
Overall | 222 | 282 | 6.9 | 6.0 | 0.94 (0.79 to 1.12) | 0.48 | |
eGFR≥60 | 136 | 180 | 6.1 | 5.6 | 0.89 (0.71 to 1.11) | 0.30 | 0.49 |
eGFR<60 | 86 | 102 | 8.8 | 6.8 | 1.03 (0.77 to 1.37) | 0.85 |
Analyses 1: as-treated analyses; analyses 2: intention-to-treat analyses; analyses 3: time-varying analyses. IR, incidence rate; PY, person-years; HR, hazard ratio; 95% CI, 95% confidence interval; P-inter, P-for-interaction.